Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT06943456
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-29
First Post:
2025-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Outcome of Open Appendectomy With and Without Transversus Abdominis Plane (TAP) Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001064', 'term': 'Appendicitis'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002429', 'term': 'Cecal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003766', 'term': 'Dental Occlusion'}], 'ancestors': [{'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D009063', 'term': 'Dental Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned to one of two parallel groups:\n\nGroup A will receive a Transversus Abdominis Plane (TAP) block following open appendectomy.\n\nGroup B will undergo the same surgical procedure without a TAP block.\n\nEach group will receive only one type of intervention, and both will be observed independently for outcomes such as postoperative pain, complications, and hospital stay.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 136}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-24', 'studyFirstSubmitDate': '2025-04-16', 'studyFirstSubmitQcDate': '2025-04-16', 'lastUpdatePostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Pain', 'timeFrame': '12, 16, and 24 hours post-surgery', 'description': "Postoperative pain will be measured using the Visual Analog Scale (VAS) at 12, 16, and 24 hours post-surgery. The VAS is a scale where 0 represents no pain and 10 represents the worst possible pain. Patients will mark their pain intensity on a 10 cm line, and the score is measured by the distance (in centimeters) from the 'no pain' mark to the point marked by the patient. This scale provides a continuous variable to assess pain intensity, allowing a detailed understanding of pain levels over time. The VAS score will be used to compare the pain outcomes between the two groups (TAP block versus no TAP block)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Appendicitis', 'Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'This study is being conducted to compare two types of pain management techniques in patients undergoing open appendectomy (surgical removal of the appendix through a traditional incision).\n\nOne group of patients will receive a Transversus Abdominis Plane (TAP) block, a type of regional anesthesia given at the end of surgery to numb the abdominal area and reduce pain. The other group will undergo the same surgery without receiving the TAP block.\n\nThe purpose of this study is to find out whether adding the TAP block helps in:\n\nReducing postoperative pain\n\nShortening the hospital stay\n\nMinimizing complications like nausea, vomiting, and delayed mobility\n\nImproving patient satisfaction after surgery\n\nOpioid medications are commonly used for pain control after surgery, but they come with side effects such as nausea, vomiting, dizziness, and risk of dependency. TAP block offers a promising alternative that may reduce or eliminate the need for opioids by targeting specific nerves in the abdominal wall.\n\nThis will be a randomized controlled trial (considered the gold standard in medical research), meaning patients will be randomly assigned to one of the two groups to ensure fair comparison. The study will enroll 136 adult patients who are diagnosed with appendicitis and are scheduled for open appendectomy at Jinnah Hospital Lahore.\n\nBy conducting this study, the researchers aim to provide strong scientific evidence on whether TAP block should be routinely used in appendectomy patients to enhance recovery and comfort. If proven effective, this could influence hospital protocols and improve post-surgery care both locally and internationally.', 'detailedDescription': 'Open appendectomy is one of the most frequently performed emergency surgeries worldwide for the treatment of acute appendicitis. Postoperative pain following this surgery can delay recovery, prolong hospital stay, and increase the risk of complications such as respiratory distress and venous thromboembolism due to reduced mobility.\n\nTraditionally, postoperative pain is managed using systemic analgesics, particularly opioids. However, opioids are associated with significant side effects such as nausea, vomiting, respiratory depression, gastrointestinal disturbances, dizziness, urinary retention, and risk of dependence. This has prompted the search for safer and more effective alternatives, especially in resource-limited settings.\n\nThe Transversus Abdominis Plane (TAP) block is a regional anesthesia technique that involves the injection of local anesthetics into the fascial plane between the internal oblique and transversus abdominis muscles. This approach targets the sensory nerves supplying the anterior abdominal wall (T6-L1), providing effective somatic pain relief.\n\nSeveral international studies have indicated that TAP block can significantly reduce postoperative pain scores and opioid consumption, particularly in abdominal surgeries. However, most of these studies are either retrospective or conducted outside the local context. In Pakistan, limited data exists, and the use of TAP block is not yet widespread or standardized in clinical practice.\n\nThis randomized controlled trial (RCT) is designed to evaluate the efficacy of TAP block in adult patients undergoing open appendectomy at Jinnah Hospital, Lahore. The study will enroll 136 participants, who will be randomized into two equal groups:\n\nGroup A will receive a TAP block with 10 ml of 1% lignocaine and 10 ml of 0.5% bupivacaine administered under direct vision at the end of the surgery.\n\nGroup B will undergo the same surgical procedure without the TAP block.\n\nAll surgeries will follow a standardized open appendectomy technique using a gridiron or Lanz incision. The TAP block will be performed in the midaxillary line between the anterior superior iliac spine and the subcostal margin under direct vision.\n\nPain will be assessed using the Visual Analog Scale (VAS) at multiple time points postoperatively (12, 16, and 24 hours). Additional parameters such as duration of hospital stay, postoperative complications (e.g., nausea, vomiting, delayed mobilization), and overall patient satisfaction will also be recorded.\n\nThe results from this study will help determine whether TAP block should be recommended as part of standard postoperative analgesia for open appendectomy. If the TAP block is found to be effective, it may reduce reliance on opioids, improve recovery times, and enhance patient outcomes-supporting broader implementation in surgical practices, especially in public-sector hospitals across developing regions.\n\nThis study adheres to ethical standards, with approval from the institutional ethical review committee, and informed consent will be obtained from all participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 to 65 years.\n* Both male and female patients.\n* Patients fit for general anesthesia.\n* Clinical findings of appendicitis.\n* Lower right quadrant or periumbilical pain radiating to the right lower quadrant, with nausea and/or vomiting.\n* Fever \\>38°C.\n* Tenderness with Alvarado score \\>7.\n\nExclusion Criteria:\n\n* Duration of symptoms \\>5 days.\n* Absence of clinical findings of appendicitis.\n* Palpable mass on physical examination suspected for appendiceal abscess.\n* History of cirrhosis or hematological disorders.\n* Allergic to or contraindicated for general anesthesia.\n* Pregnancy.\n* Patients who do not consent to participate.'}, 'identificationModule': {'nctId': 'NCT06943456', 'briefTitle': 'Comparison of Outcome of Open Appendectomy With and Without Transversus Abdominis Plane (TAP) Block', 'organization': {'class': 'OTHER', 'fullName': 'University of Health Sciences Lahore'}, 'officialTitle': 'Comparison of Outcome of Open Appendectomy With and Without Transversus Abdominis Plane Block', 'orgStudyIdInfo': {'id': 'Exp131'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Open Appendectomy with Transversus Abdominis Plane (TAP) Block', 'description': 'Patients in this group will undergo open appendectomy followed by the administration of a Transversus Abdominis Plane (TAP) block. The TAP block will be performed using a mixture of 10 ml of 1% lignocaine and 10 ml of 0.5% bupivacaine, injected between the transversus abdominis and internal oblique muscles under vision. This intervention is designed to provide localized post-operative analgesia and reduce the need for systemic opioid analgesics.', 'interventionNames': ['Procedure: Transversus Abdominis Plane (TAP) Block for Postoperative Pain Management']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Open Appendectomy without Transversus Abdominis Plane (TAP) Block', 'description': 'Patients in this group will undergo open appendectomy using the standard surgical technique without the administration of a Transversus Abdominis Plane (TAP) block. Post-operative pain will be managed using standard opioid analgesia as required, without the benefit of the TAP block for localized pain relief.', 'interventionNames': ['Procedure: Standard Open Appendectomy with Postoperative Pain Management']}], 'interventions': [{'name': 'Transversus Abdominis Plane (TAP) Block for Postoperative Pain Management', 'type': 'PROCEDURE', 'description': 'The intervention involves the administration of a Transversus Abdominis Plane (TAP) block performed at the end of an open appendectomy surgery. A mixture of 10 ml of 1% lignocaine and 10 ml of 0.5% bupivacaine is injected into the transversus abdominis plane, located between the transversus abdominis and internal oblique muscles, under direct vision. This procedure aims to provide localized pain relief by blocking the sensory nerves of the anterior abdominal wall, reducing the need for systemic opioid analgesics during post-operative recovery', 'armGroupLabels': ['Open Appendectomy with Transversus Abdominis Plane (TAP) Block']}, {'name': 'Standard Open Appendectomy with Postoperative Pain Management', 'type': 'PROCEDURE', 'description': 'The intervention involves the standard open appendectomy surgical procedure without the addition of a Transversus Abdominis Plane (TAP) block. Postoperative pain management in this group is managed using standard opioid analgesics. No local anesthetic block is performed, and pain management is entirely reliant on systemic medications, including opioids, for post-operative recovery', 'armGroupLabels': ['Open Appendectomy without Transversus Abdominis Plane (TAP) Block']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hafiz Rana Kamran Ijaz, MS General Surgery', 'role': 'CONTACT', 'email': 'beekeeperrkrajput@gmail.com', 'phone': '0331-4745037'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Health Sciences Lahore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Hafiz Rana Kamran Ijaz', 'investigatorAffiliation': 'University of Health Sciences Lahore'}}}}