Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT06913205
Status:
COMPLETED
Last Update Posted:
2025-04-06
First Post:
2025-03-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Rectus Sheath Block and Local Wound Infiltration in Pediatric Laparoscopic Appendectomies
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 145}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-30', 'studyFirstSubmitDate': '2025-03-29', 'studyFirstSubmitQcDate': '2025-03-30', 'lastUpdatePostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analgesic consumption', 'timeFrame': 'Postoperative first 24 hours.', 'description': 'Total acetaminophen use in the first 24 hours after surgery'}], 'secondaryOutcomes': [{'measure': 'Postoperative pain scores', 'timeFrame': 'Postoperative first 24 hours.', 'description': 'Pain scores will be evaluated in the postoperative period using the Wong-Baker Faces Pain Rating Scale, where zero is equivalent to no pain, and 10 indicates the worst possible pain.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['laparoscopic appendectomy', 'pediatric anesthesia', 'nerve blocks', 'regional anesthesia', 'acute postoperative pain'], 'conditions': ['Appendectomy, Laparoscopic', 'Pediatric Anesthesia', 'Nerve Block/Methods', 'Regional Anesthesia', 'Acute Pain, Postoperative']}, 'referencesModule': {'references': [{'pmid': '25581711', 'type': 'BACKGROUND', 'citation': 'Hamill JK, Liley A, Hill AG. Rectus sheath block for laparoscopic appendicectomy: a randomized clinical trial. ANZ J Surg. 2015 Dec;85(12):951-6. doi: 10.1111/ans.12950. Epub 2015 Jan 12.'}, {'pmid': '24112856', 'type': 'BACKGROUND', 'citation': 'Liu Y, Seipel C, Lopez ME, Nuchtern JG, Brandt ML, Fallon SC, Manyang PA, Tjia IM, Baijal RG, Watcha MF. A retrospective study of multimodal analgesic treatment after laparoscopic appendectomy in children. Paediatr Anaesth. 2013 Dec;23(12):1187-92. doi: 10.1111/pan.12271. Epub 2013 Sep 25.'}, {'pmid': '21958060', 'type': 'BACKGROUND', 'citation': 'Tomecka MJ, Bortsov AV, Miller NR, Solano N, Narron J, McNaull PP, Ricketts KJ, Lupa CM, McLean SA. Substantial postoperative pain is common among children undergoing laparoscopic appendectomy. Paediatr Anaesth. 2012 Feb;22(2):130-5. doi: 10.1111/j.1460-9592.2011.03711.x. Epub 2011 Sep 29.'}, {'pmid': '41023777', 'type': 'DERIVED', 'citation': 'Gurbuz H, Karasu D, Dogan AK, Kilicarslan N. Rectus sheath blocks for pediatric laparoscopic appendicectomy. BMC Anesthesiol. 2025 Sep 29;25(1):462. doi: 10.1186/s12871-025-03364-9.'}]}, 'descriptionModule': {'briefSummary': 'Laparoscopic appendectomy surgeries are among the most commonly performed procedures in childhood. However, they are associated with moderate to severe postoperative pain. Regional nerve block techniques are recommended for postoperative pain management. This research compared the two most frequently used methods: rectus sheath block and local wound infiltration.', 'detailedDescription': 'Acute appendectomy surgeries are one of the most frequently performed surgeries in childhood. Minimally invasive (laparoscopic) surgical methods are recommended, especially in abdominal surgeries, due to rapid wound healing, rapid recovery, less bleeding, and shorter hospital stays compared to open surgery. In addition to all these advantages of laparoscopic surgeries, postoperative somatic pain is expected to be less compared to open surgeries due to the small incisions in the abdominal wall. However, when the pain severity of children who underwent laparoscopic appendectomy was evaluated using the pain scoring scale, it was seen that the median pain scores were ≥7 in 5% of the children (severe pain) and ≥4 in 25% (moderate pain). Clinical practice guidelines also recommend the use of regional anesthesia and analgesia methods as part of multimodal analgesia in the prevention of intraoperative and postoperative pain. We also routinely use regional anesthesia and analgesia methods successfully and effectively in our daily practices in our clinic.\n\nRectus sheath blocks, which are known to be effective in midline incisions, and local anesthetic infiltrations of the wound site, which do not require special technical knowledge about regional anesthesia, are routinely applied in our clinic in every case. Although both methods provide clinical benefits, it is unknown which one is superior to the other.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '8 Years', 'genderBased': False, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children undergoing laparoscopic appendectomy surgery in Bursa Yuksek Ihtisas Training and Research Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Older than 8 years\n* Younger than 18 years\n* Minimal invasive appendectomy (3 port)\n* Consent to participate\n\nExclusion Criteria:\n\n* Younger than 8 years\n* Older than 18 years\n* Convert to open abdominal surgery\n* Do not consent to participate'}, 'identificationModule': {'nctId': 'NCT06913205', 'briefTitle': 'Rectus Sheath Block and Local Wound Infiltration in Pediatric Laparoscopic Appendectomies', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bursa City Hospital'}, 'officialTitle': 'Comparison of Regional Block Techniques Used for Postoperative Pain Management in Laparoscopic Appendectomy in Children', 'orgStudyIdInfo': {'id': '2011-KAEK-25 2021/08-20'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rectus Sheath Block', 'description': 'Children undergoing laparoscopic appendectomy with rectus sheath blocks'}, {'label': 'Local infiltration', 'description': 'Children undergoing laparoscopic appendectomy with local infiltration'}]}, 'contactsLocationsModule': {'locations': [{'zip': '16110', 'city': 'Bursa', 'state': 'Bursa', 'country': 'Turkey (Türkiye)', 'facility': 'University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital', 'geoPoint': {'lat': 40.19559, 'lon': 29.06013}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The data sets used in this research may be made available upon reasonable request to the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bursa City Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof. MD. PhD', 'investigatorFullName': 'Hande Gurbuz', 'investigatorAffiliation': 'Bursa City Hospital'}}}}