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. (TAP)

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

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?

Study Overview

• Status: Completed
• Conditions: the Efficacy of Analgesia of Laparoscopic TAP Block in Minimally Invasive Gynecology Surgeries
• Intervention / Treatment: Drug: TAP block with liposomal bupivacaine and bupivacaine

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 .

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Farinaz Seifi, MD, FACOG; Phone Number: (203) 785-5545; Email: farinaz.seifi@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06492
      • Yale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Farinaz Seifi, MD, FACOG, Yale University Obstetrics, Gynecology & Reproductive Sciences

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): October 15, 2023
• Study Completion (Actual): October 15, 2023

Study Registration Dates

• First Submitted: April 1, 2020
• First Submitted That Met QC Criteria: April 9, 2020
• First Posted (Actual): April 14, 2020

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: TAP block , laparoscopy , minimally invasive gynecology
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 2000026422; No NIH funding (Other Identifier: 10.11.23)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No