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.

Study Overview
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Brief Summary
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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?

Detailed Description
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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 .

Official Title
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Efficacy of Laparoscopic-assisted Transversus Abdominus Plane (TAP) Block in Minimally Invasive Gynecologic Surgeries: A Prospective, Randomized Control Trial.

Conditions
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the Efficacy of Analgesia of Laparoscopic TAP Block in Minimally Invasive Gynecology Surgeries

Intervention / Treatment
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* Drug: TAP block with liposomal bupivacaine and bupivacaine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laparoscopic assisted TAP block<br>Laparoscopic assisted TAP block will be done by surgeon intra-operatively | Drug: TAP block with liposomal bupivacaine and bupivacaine<br>* injecting the mixture of bupivacaine with liposomal bupivacaine in transversus abdominis plane to block the somatic nerves<br>|
| No Intervention: no TAP block<br>no TAP block would be done | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain scores at 24 hours in LA-TAP and NO TAP block groups | numeric pain score (NPS)pain scores at 24 hours will include the average pain score at rest reported by the patient in the first 24 hours. | 24 hour post op | 
| Amount and type of opioid consumption , based on Questionnaire's information . between LA-TAP , UG-TAP and No TAP groups at 24 hours post operatively | MME will be calculated as the cumulative amount of opioid intake in the 24 hours following anesthesia end time. | 24 hour post op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric pain score (NPS) based on questionnaire's information at 48 hours & 72 hours post operatively , in LA-TAP , UG-TAp and no TAP groups | numeric pain score (NPS) | 48 -72 hour post operative | 
| amount of narcotic , per milligram and type of opiod consumption at 48 & 72 hours post operatively ? | morphine equivalent dose of narcotic use | 48 -72 hours post operative | 
| Nausea and vomiting post operatively , based on questionnaire's information at first 72 h post op | nausea and vomiting, yes or no . | first 72 hours post operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAP block , laparoscopy , minimally invasive gynecology