Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-03-14 @ 8:37 AM
Study NCT ID:
NCT02299167
Status:
COMPLETED
Last Update Posted:
2020-11-24
First Post:
2014-11-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Minimal Effective Dose of Hyperbaric Spinal Bupivacaine for Saddle Block
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rmetwalli@iau.edu.sa', 'phone': '+966 50 289 3485', 'title': 'Roshdi R. Al-Metwalli', 'organization': 'Dammam University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '24 hours', 'description': 'Postoperative complications\n\nPDPH 0 (0-0) Urinary retention 0 (0-0) backache 0 (0-0)', 'eventGroups': [{'id': 'EG000', 'title': 'Single Group Study / Saddle Block', 'description': "The dose of bupivacaine given to each patient was determined by the response of the previously tested patient using a modified Dixon's up-and-down method (using 0.5 mg as a step size) (16). The first patient was tested at a dose 1.5 mg bupivacaine, if the patient responded with a failed block then the next patient received an increment of 0.5mg bupivacaine, if the patient responded with a successful block, then the next patient received a decrement of 0.5mg bupivacaine. The research continued until we obtained seven crossover midpoints.", 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Minimal Effective Dose of Hyperbaric Bupivacaine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Group Study / Saddle Block', 'description': "The dose of bupivacaine given to each patient was determined by the response of the previously tested patient using a modified Dixon's up-and-down method\n\nDixon's up-and-down method: using a modified Dixon's up-and-down method (using 0.5 mg as a step size) (16). The first patient was tested at a dose 1.5 mg bupivacaine, if patient responded with failed block then the next patient received an increment of 0.5mg bupivacaine, if patient responded with successful block, then the next patient received a decrement of 0.5mg bupivacaine. The research continued until we obtained seven crossover midpoints."}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '2.1'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Mean (95% CI) of effective dose in 90% (', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.9', 'ciLowerLimit': '1.7', 'ciUpperLimit': '2.1', 'estimateComment': "The ED50% of spinal bupivacaine was estimated using a modified Dixon's up-and-down method", 'groupDescription': 'Descriptive statistics were considered to calculate the mathematic mean (SD) of demographic, surgical, and other postoperative continuous data and to calculate the median (range) of sensory and motor block levels, as well as the degree of patient and surgeon satisfaction', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "The ED50% of spinal bupivacaine was estimated using a modified Dixon's up-and-down method"}], 'paramType': 'MEAN', 'timeFrame': '10 min after dural puncture', 'description': "the minimal effective dose of hyperbaric bupivacaine using a modified Dixon's up-and-down method (using 0.5 mg as a step size) (16). The first patient was tested at a dose 1.5 mg bupivacaine, if patient responded with failed block then the next patient received an increment of 0.5mg bupivacaine, if patient responded with successful block, then the next patient received a decrement of 0.5mg bupivacaine. The research continued until we obtained seven crossover midpoints.", 'unitOfMeasure': 'milligrams', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sacral Level of Sensory Block', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Group Study / Saddle Block', 'description': "The dose of bupivacaine given to each patient was determined by the response of the previously tested patient using a modified Dixon's up-and-down method\n\nDixon's up-and-down method: using a modified Dixon's up-and-down method (using 0.5 mg as a step size) (16). The first patient was tested at a dose 1.5 mg bupivacaine, if patient responded with failed block then the next patient received an increment of 0.5mg bupivacaine, if patient responded with successful block, then the next patient received a decrement of 0.5mg bupivacaine. The research continued until we obtained seven crossover midpoints."}], 'classes': [{'title': 'Maximum blocked dermatome', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '4'}]}]}, {'title': 'At conclusion of surgery', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '4'}]}]}, {'title': 'Immediately before surgery', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'every 30 min until complete regression of the block (approximately 90 min)', 'description': 'The level of sensory block was tested using a long surgical toothless clamp gently applied radially, starting from the anal orifice, in different diagonal directions', 'unitOfMeasure': 'Sacral level of sensory block', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '* Immediately before surgery S4 (S3-S4)\n* At conclusion of surgery S4 (S3-S4)\n* Maximum blocked dermatome S4 (S3-S4)'}, {'type': 'SECONDARY', 'title': 'Motor Block Score as Assessed Using the Bromage Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Group Study / Saddle Block', 'description': "The dose of bupivacaine given to each patient was determined by the response of the previously tested patient using a modified Dixon's up-and-down method\n\nDixon's up-and-down method: using a modified Dixon's up-and-down method (using 0.5 mg as a step size) (16). The first patient was tested at a dose 1.5 mg bupivacaine, if patient responded with failed block then the next patient received an increment of 0.5mg bupivacaine, if patient responded with successful block, then the next patient received a decrement of 0.5mg bupivacaine. The research continued until we obtained seven crossover midpoints."}], 'classes': [{'title': 'Immediately before surgery', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'At conclusion of surgery 0 Aided patient positioni', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'every 30 min until Time to ambulation (approximately 2 hours)', 'description': 'The motor block was tested by a modified Bromage scale (0 = no motor block, 1 = able to flex the ankle and bend knees, 2 = able to flex ankle, and 3 = full motor block). A successful block was defined as one that was sufficient to proceed with the surgery without any supplementation (intravenous analgesic, local anesthetic infiltration, or general anesthesia).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The block characteristics for patients with successful block (12 patients)'}, {'type': 'SECONDARY', 'title': "Patient's Satisfactions", 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Group Study / Saddle Block', 'description': "The dose of bupivacaine given to each patient was determined by the response of the previously tested patient using a modified Dixon's up-and-down method\n\nDixon's up-and-down method: using a modified Dixon's up-and-down method (using 0.5 mg as a step size) (16). The first patient was tested at a dose 1.5 mg bupivacaine, if patient responded with failed block then the next patient received an increment of 0.5mg bupivacaine, if patient responded with successful block, then the next patient received a decrement of 0.5mg bupivacaine. The research continued until we obtained seven crossover midpoints."}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours after surgery', 'description': "Patient's satisfactions were evaluated with a 4-point satisfaction score (0=poor satisfaction, 1=good satisfaction 2=very good satisfaction, 3= excellent satisfaction", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All patient with successful block were satisfied'}, {'type': 'SECONDARY', 'title': "Surgeon's Satisfactions", 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Group Study / Saddle Block', 'description': "The dose of bupivacaine given to each patient was determined by the response of the previously tested patient using a modified Dixon's up-and-down method\n\nDixon's up-and-down method: using a modified Dixon's up-and-down method (using 0.5 mg as a step size) (16). The first patient was tested at a dose 1.5 mg bupivacaine, if patient responded with failed block then the next patient received an increment of 0.5mg bupivacaine, if patient responded with successful block, then the next patient received a decrement of 0.5mg bupivacaine. The research continued until we obtained seven crossover midpoints."}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours after procedure', 'description': "Surgeon's satisfactions were evaluated with a 4-point satisfaction score (0=poor satisfaction, 1=good satisfaction 2=very good satisfaction, 3= excellent satisfaction", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All surgeon who operated on the patient with successful block (12 patients ) were satisfied'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Single Group Study / Saddle Block', 'description': "The dose of bupivacaine given to each patient was determined by the response of the previously tested patient using a modified Dixon's up-and-down method\n\nDixon's up-and-down method: using a modified Dixon's up-and-down method (using 0.5 mg as a step size) (16). The first patient was tested at a dose 1.5 mg bupivacaine, if patient responded with failed block then the next patient received an increment of 0.5mg bupivacaine, if patient responded with successful block, then the next patient received a decrement of 0.5mg bupivacaine. The research continued until we obtained seven crossover midpoints."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}]}, {'type': 'Dural Puncture', 'comment': 'Dural puncture to inject the study drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'Success Rate', 'comment': '10 min after Dural puncture (to test the success of the block)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'Adverse Effects', 'comment': '24 after surgery to record any complication', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'patients were excluded from the study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}]}]}], 'recruitmentDetails': 'Four independent anesthetists were assigned for the study from January 2014.one to select patients in the anesthesia clinic, the 2nd to prepare the studied drug in the OR, the 3rd one to inject the drug and the 4th one was to collect the data', 'preAssignmentDetails': '35 patients were enrolled However; after they have signed the consent. 7 patients were excluded because they have received analgesics in the morning of surgery. and 4 patients refused the saddle block in the operating room. So actually 24 patients out of 35 participants underwent intervention. That has been already specified in the protocol'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Saddle Block', 'description': "The dose of bupivacaine given to each patient was determined by the response of the previously tested patient using a modified Dixon's up-and-down method\n\nDixon's up-and-down method: using a modified Dixon's up-and-down method (using 0.5 mg as a step size) (16). The first patient was tested at a dose 1.5 mg bupivacaine, if patient responded with failed block then the next patient received an increment of 0.5mg bupivacaine, if patient responded with successful block, then the next patient received a decrement of 0.5mg bupivacaine. The research continued until we obtained seven crossover midpoints."}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': '11 patients have been excluded from study. The remaining 24 participants completed the study.', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.71', 'spread': '10.24', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Saudi Arabia', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '11 patients have been excluded from the study. The remaining 24 participants completed the study'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-02', 'studyFirstSubmitDate': '2014-11-19', 'resultsFirstSubmitDate': '2020-08-15', 'studyFirstSubmitQcDate': '2014-11-20', 'lastUpdatePostDateStruct': {'date': '2020-11-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-02', 'studyFirstPostDateStruct': {'date': '2014-11-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Minimal Effective Dose of Hyperbaric Bupivacaine', 'timeFrame': '10 min after dural puncture', 'description': "the minimal effective dose of hyperbaric bupivacaine using a modified Dixon's up-and-down method (using 0.5 mg as a step size) (16). The first patient was tested at a dose 1.5 mg bupivacaine, if patient responded with failed block then the next patient received an increment of 0.5mg bupivacaine, if patient responded with successful block, then the next patient received a decrement of 0.5mg bupivacaine. The research continued until we obtained seven crossover midpoints."}], 'secondaryOutcomes': [{'measure': 'Sacral Level of Sensory Block', 'timeFrame': 'every 30 min until complete regression of the block (approximately 90 min)', 'description': 'The level of sensory block was tested using a long surgical toothless clamp gently applied radially, starting from the anal orifice, in different diagonal directions'}, {'measure': 'Motor Block Score as Assessed Using the Bromage Scale', 'timeFrame': 'every 30 min until Time to ambulation (approximately 2 hours)', 'description': 'The motor block was tested by a modified Bromage scale (0 = no motor block, 1 = able to flex the ankle and bend knees, 2 = able to flex ankle, and 3 = full motor block). A successful block was defined as one that was sufficient to proceed with the surgery without any supplementation (intravenous analgesic, local anesthetic infiltration, or general anesthesia).'}, {'measure': "Patient's Satisfactions", 'timeFrame': '24 hours after surgery', 'description': "Patient's satisfactions were evaluated with a 4-point satisfaction score (0=poor satisfaction, 1=good satisfaction 2=very good satisfaction, 3= excellent satisfaction"}, {'measure': "Surgeon's Satisfactions", 'timeFrame': '24 hours after procedure', 'description': "Surgeon's satisfactions were evaluated with a 4-point satisfaction score (0=poor satisfaction, 1=good satisfaction 2=very good satisfaction, 3= excellent satisfaction"}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Perianal surgery', 'hyperbaric bupivacaine', 'saddle block'], 'conditions': ['Perianal Surgery']}, 'descriptionModule': {'briefSummary': "The optimal anesthetic technique would provide excellent operating conditions, rapid recovery, early discharge, no postoperative side effects, and high patient's satisfaction. In addition to increasing the quality and decreasing the costs of the anesthetic services (1). Selective spinal anesthesia (SSA) -spinal block with minimal effective doses for a specific type of surgery - has become very popular technique) 2(for some orthopedic and gynecological surgeries \\[3-9\\].\n\nSaddle anesthesia is a SSA directs a small bolus of hyperbaric local anesthetic, towards S4-S5 and coccygeal nerve roots (11), and is commonly utilized for perianal surgeries (11-14). Hyperbaric bupivacaine has been safely, replaced hyperbaric Lidocaine for saddle block (11, 12).\n\nAlthough Saddle blocks at different low doses of hyperbaric bupivacaine (1.5- 4 mg) have been used previously for mi¬nor perianal surgeries (11, 13, 14), the optimal effective dose has yet to be determined.\n\nThe objective of this study is to determine the minimal effective dose of hyperbaric spinal bupivacaine required to induce a reliable and satisfactory saddle block for perianal surgeries (using a modified Dixon's up-and-down method.", 'detailedDescription': "Following approval of the Research and Ethics Committee of the University of Dammam and written informed consent, patients with American Society of Anesthesiologists physical Status I and II, aged 20-55 years, scheduled for outpatient elective perianal surgery in the lithotomy position ( hemorrhoidectomy, fistulectomy), were prospectively enrolled in this study. Patients unwilling to participate, those with contraindications to regional anesthesia, morbid obesity, bleeding disorders, mental health problems or language barriers, taking psychotropic or analgesic medication, or a known history of allergic reactions to amide local anesthetics, were excluded from the study.\n\nActually, 35 patients were enrolled. However; after they have signed the informed consent; 7 patients were excluded because they have received analgesics in the morning of surgery, and 4 patients refused to receive the saddle block on the operating room. So actually 24 patients out of 35 participants underwent intervention\n\nAll patients were fasted for over 6 hours and were premedicated with 0.2 mg/kg oral diazepam 60 min before spinal anesthesia.\n\nIn the operating room (OR), an intravenous (IV) 18-20G catheter was placed, and standard monitoring \\[electrocardiogram (ECG), heart rate (HR), oxygen saturation (SpO2), and noninvasive blood pressure (NIBP)\\] were started.\n\nUnder aseptic conditions, the dural puncture was performed by staff-grade anesthesiologists, using a standard midline approach in the sitting position at the L3-L4 or L4-L5 intervertebral space, using a 25-gauge Whitacre needle with its orifice directed caudally. A predetermined small dose of hyperbaric bupivacaine (Marcaine Spinal Heavy; Astra Zeneca, Lund, Sweden) which was prepared in1 mL tuberculin syringe was injected. All patients remained in the sitting position for 10 min. the patient was asked if he/she perceived any change in motor power.\n\nIf not, the patient was allowed to position him/herself without aid for surgery in the lithotomy position. Immediately before surgery, the sacral level of sensory block was tested using a long surgical toothless clamp gently applied radially, starting from the anal orifice, in different diagonal directions.\n\nThe motor block was tested by a modified Bromage scale (0 = no motor block, 1 = able to flex the ankle and bend knees, 2 = able to flex ankle, and 3 = full motor block).\n\nA successful block was defined as one that was sufficient to proceed with the surgery without any supplementation (intravenous analgesic, local anesthetic infiltration, or general anesthesia).\n\nThe dose of bupivacaine given to each patient was determined by the response of the previously tested patient using a modified Dixon's up-and-down method (using 0.5 mg as a step size) (16).\n\nThe first patient was tested at a dose 1.5 mg bupivacaine, if the patient responded with a failed block then the next patient received an increment of 0.5 mg bupivacaine, if the patient responded with a successful block, then the next patient received a decrement of 0.5 mg bupivacaine.\n\nThe research continued until the investigators obtained seven crossover midpoints. The initial starting dose of 1.5 mg hyperbaric bupivacaine of the first patient was selected from the findings of Wassef R et al. who demonstrated adequate anesthesia for short perianal surgery with the use of 1.5 mg spinal hyperbaric bupivacaine.\n\nBupivacaine was prepared immediately before injection by an independent anesthesiologist and was administered by a second anesthesiologist. Block assessment and clinical follow-up of the patients was also performed by a third anesthesiologist.\n\nThe following data were recorded; Patient demographics, duration of anesthesia and surgery, level of sensory and motor block immediately before surgery, at the end of the surgery, and every 30 minutes until resolution of the block. NIBP and HR were documented every 5 minutes in the OR and PACU. Also Times to ambulation, first voiding time, and time to home discharge were recorded. Patient's and surgeon's satisfaction were evaluated with a 4-point score (0=poor, 1=good, 2=very good, 3= excellent). Patients were followed by phone call to note down any possible postoperative complication (postdural puncture headache, TNS or backache) at day 1 postoperatively and 10 days later. The time of the dural puncture was used as the primary starting point of assessment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists physical Status I and II patients.\n* Scheduled for outpatient elective perianal surgery.\n\nExclusion Criteria:\n\n* Patients unwilling to participate.\n* Contraindications to regional anesthesia.\n* Morbid obesity.\n* Bleeding disorders.\n* Mental health problems.\n* Language barrier.\n* Taking psychotropic or analgesic medication.\n* History of allergic reactions to amide local anesthetics.'}, 'identificationModule': {'nctId': 'NCT02299167', 'briefTitle': 'Minimal Effective Dose of Hyperbaric Spinal Bupivacaine for Saddle Block', 'organization': {'class': 'OTHER', 'fullName': 'Imam Abdulrahman Bin Faisal University'}, 'officialTitle': 'The Minimal Effective Dose of Hyperbaric Spinal Bupivacaine for Successful Reliable Saddle Block for Minor Perianal Surgeries', 'orgStudyIdInfo': {'id': 'ANE-2014-1-23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Saddle block', 'description': "The dose of bupivacaine given to each patient was determined by the response of the previously tested patient using a modified Dixon's up-and-down method", 'interventionNames': ["Drug: Dixon's up-and-down method"]}], 'interventions': [{'name': "Dixon's up-and-down method", 'type': 'DRUG', 'description': "using a modified Dixon's up-and-down method (using 0.5 mg as a step size) (16). The first patient was tested at a dose 1.5 mg bupivacaine, if patient responded with failed block then the next patient received an increment of 0.5mg bupivacaine, if patient responded with successful block, then the next patient received a decrement of 0.5mg bupivacaine. The research continued until we obtained seven crossover midpoints.", 'armGroupLabels': ['Saddle block']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Roshdi Al Metwalli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor at Anesthesiology Dept'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imam Abdulrahman Bin Faisal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}