Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2026-01-03 @ 3:12 AM
Study NCT ID:
NCT05301595
Status:
WITHDRAWN
Last Update Posted:
2023-11-07
First Post:
2022-03-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TAP vs QL for Postoperative Analgesia After DIEP Free Flap Breast Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Patients will be randomized by using forty-six sealed, opaque envelopes to receive a TAP block or QL block.\n\nThis is a double-blind study. Patient, surgeon and study staff will know which group patient has been assigned to. The anesthetist will know which group you are in for logistical purposes. The patient and surgeon will not know which nerve block the patient received.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomized to receive intraoperative TAP block (Group A) or preoperative ultrasound- guided QL block (Group B).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study was never started as PI moved to another city', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-05', 'studyFirstSubmitDate': '2022-03-08', 'studyFirstSubmitQcDate': '2022-03-19', 'lastUpdatePostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Recovery-15 survey', 'timeFrame': 'post-operative day #1', 'description': 'Quality of Recovery-15 (QoR-15) survey is a validated 15-item patient-rated postoperative recovery score, will be obtained on postoperative day (POD) 1. Survey results are a numerical rating scale leads to a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery). Higher scores are a better outcome.'}], 'secondaryOutcomes': [{'measure': 'Quality of Recovery-15 survey', 'timeFrame': 'post-operative day #2', 'description': 'Quality of Recovery-15 (QoR-15) survey is a validated 15-item patient-rated postoperative recovery score, will be obtained on postoperative day (POD) 2. Survey results are a numerical rating scale leads to a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery). Higher scores are a better outcome.'}, {'measure': 'Quality of Recovery-15 survey', 'timeFrame': 'post-operative day #3', 'description': 'Quality of Recovery-15 (QoR-15) survey is a validated 15-item patient-rated postoperative recovery score, will be obtained on postoperative day (POD) 3. Survey results are a numerical rating scale leads to a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery). Higher scores are a better outcome.'}, {'measure': 'Pain visual analog scale', 'timeFrame': '1st, 2nd, 4th, 8th, 12th, 16th and 24th postoperative hours', 'description': "Pain visual analog scale (VAS) is a 1 to 10 continuous scale used to determine the intensity of a patient's pain at any given time. For any given time, the minimum value is 1 (no pain) and the maximum value is 10 (pain as bad as it could possibly be). The lower the number, the less intense the pain and better outcome."}, {'measure': 'Time elapsed before first analgesic requirement', 'timeFrame': 'post-operative day #0 to 3', 'description': 'Time that has elapsed since surgery before first analgesic medication is needed.'}, {'measure': 'Total analgesic drug requirements', 'timeFrame': 'post-operative day #0 to 3', 'description': 'The total amount of analgesic medication patient requires in the first 3 days after surgery'}, {'measure': 'Total antiemetic drug requirements', 'timeFrame': 'post-operative day #0 to 3', 'description': 'The total amount of antiemetic medication patient requires in the first 3 days after surgery'}, {'measure': 'Ambulation', 'timeFrame': 'post-operative day #0 to 3', 'description': 'Ability of patient to ambulate (e.g. up to chair, mobilizing with assistance, mobilizing independently) in the first 3 days after surgery.'}, {'measure': 'Surgical complication', 'timeFrame': 'post-operative day #0 to 3', 'description': 'Any acute surgical complications experienced by the patient in the first three days after surgery.'}, {'measure': 'Block complication', 'timeFrame': 'post-operative day #0 to 3', 'description': 'Any acute nerve-block related complications experienced by the patient in the first three days after surgery.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy of Transversus abdominus plane (TAP) block and Quadratus Lumborum (QL) block on the quality of recovery after breast reconstruction with deep inferior epigastric perforator (DIEP) flap.', 'detailedDescription': "Breast reconstruction after mastectomy has seen continued growth and popularity in recent years secondary to improved surgical techniques and improved patient awareness and understanding. While implant-based reconstruction remain the most popular option, autologous tissue transfer, reconstruction of the breast with a patient's own tissues, has emerged as the gold standard for breast reconstruction, most commonly performed with abdominally-based flaps, such as the deep inferior epigastric perforator (DIEP) flap.\n\nPostoperative pain can be a difficult challenge in patients who have undergone DIEP flap. Patients with worse postoperative pain control report worse overall satisfaction with their surgical experience.\n\nA multimodal analgesia protocol is a key component in the postoperative care after DIEP flap. Regional nerve blocks present an adjunct to these protocols that can potentially improve the quality of recovery of these patients.\n\nTransversus abdominus plane (TAP) blocks have been shown to be a safe and effective technique to manage postoperative pain at the abdomen in this population; lowering usage of opiates, shortening length of stay and reducing episodes of nausea and vomiting. TAP's efficacy is well-established and documented for postoperative analgesia in abdominal surgery. This can be done preoperatively by an anesthetist via ultrasound-guidance or, using traditional technique of direct visualization, intraoperatively by the operating surgeon. Surgeon-performed intra-operative TAP block are often preferred as it is less time-consuming. TAP block has become the standard abdominal regional nerve block to perform during this procedure.\n\nMore recently, QL block has emerged as an alternative to TAP block for lower abdominal surgery. The QL block is an ultrasound-guided fascial plane block performed by an anesthetist for anterior abdominal wall analgesia.\n\nThis study will compare QL block to TAP block in patients undergoing DIEP free flap breast reconstruction."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women (age 18 years or older) who are booked for abdominally based free flap for breast reconstruction\n* Patients with America Society of Anesthesiologists (ASA) physical status class I, II and III\n\nExclusion Criteria:\n\n* Patients not consenting for regional block\n* Patients allergic to local anesthetics and adjuvants\n* Patients with America Society of Anesthesiologists (ASA) physical status class IV and V\n* Patients with any baseline opiate consumption\n* Presence of infection at needle insertion site\n* Patients with coagulopathy (INR\\>1.3)\n* Patients with thrombocytopenia (Platelets\\<100)\n* Patients on therapeutic anticoagulation'}, 'identificationModule': {'nctId': 'NCT05301595', 'briefTitle': 'TAP vs QL for Postoperative Analgesia After DIEP Free Flap Breast Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Hospital Research Institute'}, 'officialTitle': 'Transversus Abdominus Plane Block Versus Quadratus Lumborum Block for Postoperative Analgesia After Abdominal-based Free Tissue Transfer for Breast Reconstruction After Mastectomy', 'orgStudyIdInfo': {'id': '20210817-01H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TAP block', 'description': 'All patients will have paravertebral (PV) blocks of the chest performed prior to induction of general anesthesia.\n\nPatients in this group will have bilateral sham blocks performed after PV block is complete. 2ml of normal saline will be injected under the skin bilaterally near the insertion site of a typical QL block.\n\nTAP block will be performed intraoperatively by the surgeon. The anesthesiologist will provide the surgeon with 40ml of LA mixture (ropivacaine 0.25%, epinephrine 100mcg and dexamethasone 4mg) for patients in this group. The surgeon will be blinded to the injectate content. The TAP block is performed once the abdominal flap has been harvested. The triangle of Petit is landmarked by the iliac crest inferiorly, the latissimus dorsi muscle posteriorly and the external oblique muscle anteriorly. A blunt tip needle is advanced through the external oblique fascia and internal oblique fascia. A total volume 20mL of the LA mixture will be injected per side.', 'interventionNames': ['Procedure: TAP block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'QL block', 'description': 'All patients will have paravertebral (PV) blocks of the chest performed prior to induction of general anesthesia.\n\nPatients in this group will have QL block performed after PV block is complete. This will be performed with patients in the prone position using the transverse in-plane technique. With realtime U/S guidance, the quadratus lumborum muscle is identified before a short-bevel needle is advanced into the plane between the quadratus lumborum and psoas major muscles. Needle tip position is confirmed by separation of quadratus lumborum and psoas major upon injection. 20ml of ropivacaine 0.25%, epinephrine 50mcg and dexamethasone 2mg will be injected per side.\n\nTAP block is performed intraoperatively similar to above but with 40mL of normal saline to perform a sham block. The anesthesiologist will provide the surgeon with 40ml of normal saline in this group. The surgeon will be blinded to the injectate content.', 'interventionNames': ['Procedure: QL Block']}], 'interventions': [{'name': 'TAP block', 'type': 'PROCEDURE', 'description': 'Please see description of TAP block group.', 'armGroupLabels': ['TAP block']}, {'name': 'QL Block', 'type': 'PROCEDURE', 'description': 'Please see description of QL block group.', 'armGroupLabels': ['QL block']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K1S1B1', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Ottawa Hospital', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'overallOfficials': [{'name': 'Moein Momtazi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ottawa Hospital Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ottawa Hospital Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Plastic and Reconstructive Surgeon', 'investigatorFullName': 'Moein Momtazi', 'investigatorAffiliation': 'Ottawa Hospital Research Institute'}}}}