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.

Yale University

Status and phase: Completed; Phase 2

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

Treatments: Drug: TAP block with liposomal bupivacaine and bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT04345341

No NIH funding (Other Identifier)

2000026422

Details and patient eligibility

About

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?

Full 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 .

Enrollment: 80 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Laparoscopic assisted TAP block

Active Comparator group

Description:

Laparoscopic assisted TAP block will be done by surgeon intra-operatively

Treatment:

Drug: TAP block with liposomal bupivacaine and bupivacaine

no TAP block

No Intervention group

Description:

no TAP block would be done