Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2026-01-05 @ 5:48 PM
Study NCT ID:
NCT03189693
Status:
UNKNOWN
Last Update Posted:
2022-01-18
First Post:
2017-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Paravertebral Block for Pain Management After Appendectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-14', 'studyFirstSubmitDate': '2017-06-13', 'studyFirstSubmitQcDate': '2017-06-15', 'lastUpdatePostDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analgesic consumption', 'timeFrame': '24 hours postoperatively', 'description': 'The quantity of analgesics consumed will be recorded'}], 'secondaryOutcomes': [{'measure': 'hemodynamic stability measured through mean arterial pressure (MAP).', 'timeFrame': 'Approximately 1 hour', 'description': 'Intraoperative hemodynamic stability measured through mean arterial pressure (MAP)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Reduce Pain After Appendectomy']}, 'descriptionModule': {'briefSummary': 'Paravertebral Block (PVB) was shown to be a successful and useful technique of anesthesia and analgesia. Its effect was evident in thoracic and abdominal surgeries. In the setting of appendectomy, somatic PVB has been used for pediatric patients. It was shown to decrease opioid consumption and provide prolonged pain relief. Hence, it would be beneficial to examine the analgesic effect of PVB on appendectomy in adult patients.', 'detailedDescription': 'Patients undergoing appendectomy will be randomly allocated into two equal groups using the sealed envelope technique. All patients will receive general anesthesia (GA). Patients in group I will receive two PVB injections at levels T12-L1 and L1-L2 using anesthetic mixture, while patients in Group II will receive placebo.\n\nParavertebral Block Technique Unilateral right side nerve stimulator-guided PVB is performed while patients are in the left lateral decubitis position. The appropriate levels for the PVB are determined by palpation of the spinous processes. An intervertebral line is drawn at the appropriate levels and the injection site is marked 2.5 cm lateral to the midline. After aseptic preparation of the skin, 1 mL 1% lidocaine is infiltrated at the injection sites. A 21-G nerve stimulation needle (Stimuplex; B. Braun, Melsungen, Germany) is advanced 1-2 cm perpendicularly to the skin using a nerve stimulating current of 2.5-5.0 mA, while closely watching for contractions of the abdominal muscles. The tip of the needle is adjusted to maintain muscle contractions while reducing the stimulating current to approximately 0.5-0.6 mA.\n\n4 mL of the local anaesthetic mixture is injected at each injection site. Each 20 mL of the local anaesthetic mixture contains: 8mL lidocaine 2%, 8 mL lidocaine 2% with epinephrine 5µg/mL and 4 mL bupivacaine 0.5%.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Older than 18 years\n* Scheduled to undergo appendectomy\n\nExclusion Criteria:\n\n* cardiac disease,\n* developmental delay,\n* neurologic deficit,\n* allergies to any of the drugs routinely used in anesthesia management.'}, 'identificationModule': {'nctId': 'NCT03189693', 'briefTitle': 'Paravertebral Block for Pain Management After Appendectomy', 'organization': {'class': 'OTHER', 'fullName': 'Makassed General Hospital'}, 'officialTitle': 'Paravertebral Block for Postoperative Pain Management in Adult Patients Undergoing Appendectomy', 'orgStudyIdInfo': {'id': '212006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PVB group', 'description': 'Patients will receive two PVB injections at levels T12-L1 and L1-L2 using anesthetic mixture', 'interventionNames': ['Other: PVB', 'Other: GA', 'Other: Anesthetic injections']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients will receive two PVB injections containing placebo at levels T12-L1 and L1-L2', 'interventionNames': ['Other: Placebo', 'Other: GA']}], 'interventions': [{'name': 'PVB', 'type': 'OTHER', 'description': 'nerve stimulator-guided PVB will be performed at two levels', 'armGroupLabels': ['PVB group']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'nerve stimulator-guided PVB containing placebo will be performed at two levels', 'armGroupLabels': ['Placebo']}, {'name': 'GA', 'type': 'OTHER', 'description': 'All patients will receive general anesthesia.', 'armGroupLabels': ['PVB group', 'Placebo']}, {'name': 'Anesthetic injections', 'type': 'OTHER', 'description': '4 mL of the local anesthetic mixture is injected at each injection site. Each 20 mL of the local anaesthetic mixture contains: 8mL lidocaine 2%, 8 mL lidocaine 2% with epinephrine 5µg/mL and 4 mL bupivacaine 0.5%.', 'armGroupLabels': ['PVB group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beirut', 'status': 'RECRUITING', 'country': 'Lebanon', 'contacts': [{'name': 'Zoher Naja, MD', 'role': 'CONTACT', 'email': 'zouhnaja@yahoo.com', 'phone': '+9611636000', 'phoneExt': '6941'}], 'facility': 'Makassed General Hospital', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}], 'centralContacts': [{'name': 'Zoher Naja, MD', 'role': 'CONTACT', 'email': 'zouhnaja@yahoo.com', 'phone': '+9611636000', 'phoneExt': '6941'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Makassed General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chairperson of Anesthesia and Pain Management Department', 'investigatorFullName': 'Zoher Naja', 'investigatorAffiliation': 'Makassed General Hospital'}}}}