Efficacy of Laparoscopic-assisted Transversus Abdominus Plane (TAP) Block Compared to Ultrasound-guided TAP Block in Minimally Invasive Gynecologic Surgeries: A Prospective, Randomized Control Trial.
Purpose
We propose a clinical trial to determine the efficacy of Laparoscopic Transversus Abdominis Plane (LA-TAP) performed intraoperatively compared with usual postoperative analgesia without LA-TAP block. We hypothesise that there will be a decrease in postoperative opioid utilization and in pain scores for patients randomized to receive the LA-TAP block verses those who do not. We expect that patients will opt to take less break through opioid medication in the LA-TAP block group versus the no TAP block group. Investigators aim to answer the above questions through the following primary and secondary outcomes: Primary outcomes Is there a difference in pain scores reported by the patient at 24 hours following LA-TAP versus no TAP block? Is there a clinically significant difference in cumulative postoperative opioid consumption, expressed as milligram morphine equivalents (MMEs) at 24 hours following LA-TAP blocks versus no TAP block? Secondary outcomes Is there a difference between study groups in pain scores at 48 & 72 hours? Is there a difference between study groups in total opioid consumption (MMEs) by 48 & 72 hours? Is there a difference between the study groups for reported post-operative nausea and vomiting? Is there a difference between the study groups in operating time? Is there a difference between the study groups in the length of Hospital stay? Is there a difference between the study groups in patient's satisfaction?
Condition
- the Efficacy of Analgesia of Laparoscopic TAP Block in Minimally Invasive Gynecology Surgeries
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Patients 18 years old and above - English speaking - patients with capacity to consent - Elective laparoscopic and robotic benign genecology cases - Elective laparoscopy/ robotic hysterectomy - Elective laparoscopy/robotic myomectomy - ERAS (enhanced recovery after surgery) protocol applied
Exclusion Criteria
- Pregnant women - patients with positive urine pregnancy test in pre operative - emergency procedures - Procedure requiring staging or debulking - surgeries that convert to laparotomy - patients with allergy to local/systemic anaesthesia or analgesia - Inability to undergo normal anesthesia induction process - ASA III or higher - history of pain relief medication dependence - history of substance abuse - end stage chronic kidney disease - advanced liver disease - history of chronic pain - history of taking opioids or neuropathic agents regularly prior to surgery - BMI of 50 or over - skin infections at the site of TAP block injection or port sites.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Laparoscopic assisted TAP block |
Laparoscopic assisted TAP block will be done by surgeon intra-operatively |
|
|
No Intervention no TAP block |
no TAP block would be done |
|
Recruiting Locations
More Details
- NCT ID
- NCT04345341
- Status
- Completed
- Sponsor
- Yale University
Detailed Description
Investigators aim to answer the above questions through the following primary and secondary outcomes: Primary outcomes Is there a difference in pain scores reported by the patient at 24 hours following LA-TAP versus no TAP block? Is there a clinically significant difference in cumulative postoperative opioid consumption, expressed as milligram morphine equivalents (MMEs) at 24 hours following LA-TAP blocks versus no TAP block? Secondary outcomes Is there a difference between study groups in pain scores at 48 & 72 hours? Is there a difference between study groups in total opioid consumption (MMEs) by 48 & 72 hours? Is there a difference between the study groups for reported post-operative nausea and vomiting? Is there a difference between the study groups in operating time? Is there a difference between the study groups in the length of Hospital stay? Is there a difference between the study groups in patient's satisfaction? Patients will be randomized in two arms , LA-TAP , NO-TAP block . Each patient would fill out the pain score sheet and number of narcotic medications she used in first 24h, 48h and 72 h post operatively .