Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-27 @ 11:44 PM
Study NCT ID:
NCT06127394
Status:
COMPLETED
Last Update Posted:
2024-05-17
First Post:
2023-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Sacral Erector Spinae Plane Block (SESPB) on Postoperative Pain and Catheter-related Bladder Discomfort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-15', 'studyFirstSubmitDate': '2023-11-07', 'studyFirstSubmitQcDate': '2023-11-07', 'lastUpdatePostDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Catheter related bladder discomfort, 0:no discomfort 4:worst discomfort', 'timeFrame': 'baseline ,and 24 hours', 'description': 'It was evaluated with a 4-point scoring system developed and first used by Agarwall et al. . No symptoms: 0, Mild: mild discomfort that can be tolerated, Moderate: discomfort is present but not accompanied by behavioural reactions, Severe: discomfort is very severe and accompanied by body movements indicating that the patient cannot bear it.'}], 'secondaryOutcomes': [{'measure': 'Numerical Rating Scale,0 :no pain 10:worst pain', 'timeFrame': 'baseline, and 24 hours', 'description': 'The NRS score of the patients was "0: no pain, 10: the most severe pain experienced". An NRS value of 4 and above indicates that the pain is severe and rescue analgesia is required.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['regional block', 'pudendal block'], 'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the catheter related bladder discomfort in patients who will undergoing TUR-P operation. The main questions it aims to answer are:\n\n* Is sacral ESPB effective on the pudendal nerve dermatome?\n* Is sacral ESPB as useful as pudendal block on CRBD? Participants will be divided into two groups and the first group will receive sacral espb after TUR-p operation and the second group will receive pudendal block. Investigators will be present for 24 hours\n\n * catheter related bladder discomfort\n * post-operative pain,\n * additional analgesic needs will be questioned and the difference between the two groups will be evaluated.', 'detailedDescription': 'This is a prospective,randomised,double-blind, single-centre,study aiming to compare the effectiveness of US guided bilateral sacral ESPB and US guided bilateral pudendal block on CRBD and pain after TUR-P. 54 patients will be included in the study and divided into two groups. All patients will be standardly monitored and will receive general anaesthesia. At the end of the cases, sacral ESPB will be applied to the first group and pudendal block to the second group, and the patients and the data questioner physician will be blinded to the study.\n\nPrimary and secondary outcomes will be questioned for 24 hours and statistics will be made according to the result.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Only males have got prostate', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- American Society of Anesthesiologist (ASA) Physical status 1-3\n\nExclusion Criteria:\n\n* American Society of Anesthesiologist (ASA) Physical status 4-5\n* Refused to participate in the study\n* Known allergy to local anaesthetic\n* Where regional anaesthesia is contraindicated\n* With known neurological, haematological or muscular disease\n* Patients with infection or anatomical changes in the lumbo-sacral region'}, 'identificationModule': {'nctId': 'NCT06127394', 'acronym': 'SESPB', 'briefTitle': 'Efficacy of Sacral Erector Spinae Plane Block (SESPB) on Postoperative Pain and Catheter-related Bladder Discomfort', 'organization': {'class': 'OTHER', 'fullName': 'Giresun University'}, 'officialTitle': 'Comparison of the Efficacy of Sacral Erector Spinae Plane Block (SESPB) and Pudendal Block on Postoperative Pain and Catheter-related Bladder Discomfort (CRBD) in Patients Undergoing Trans-urethral Resection of the Prostate (TUR-P).', 'orgStudyIdInfo': {'id': '2023/07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'espb group', 'description': 'Block will be performed with median technique at the level of sacral 2nd vertebrae.', 'interventionNames': ['Procedure: Sacral ESP Block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'pudendal group', 'description': 'Bilateral transperineal block will be performed', 'interventionNames': ['Procedure: Pudendal Block']}], 'interventions': [{'name': 'Sacral ESP Block', 'type': 'PROCEDURE', 'description': 'Sacral ESPB median approach, 40 ml %0,25 Bupivacaine', 'armGroupLabels': ['espb group']}, {'name': 'Pudendal Block', 'type': 'PROCEDURE', 'description': 'Bilateral pudendal block, 10 ml %0,25 bupivacaine', 'armGroupLabels': ['pudendal group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28100', 'city': 'Merkez', 'state': 'Giresun', 'country': 'Turkey (Türkiye)', 'facility': 'Giresun Research and Training Hospital'}], 'overallOfficials': [{'name': 'Bilge Olgun Keleş', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Giresun University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Giresun University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Bilge Olgun Keles', 'investigatorAffiliation': 'Giresun University'}}}}