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.

NCT ID: NCT04345341

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2023-10-15

Brief Summary

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

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 .

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Laparoscopic assisted TAP block

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

Group Type: ACTIVE_COMPARATOR

TAP block with liposomal bupivacaine and bupivacaine

Intervention Type: DRUG

injecting the mixture of bupivacaine with liposomal bupivacaine in transversus abdominis plane to block the somatic nerves

no TAP block

no TAP block would be done

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

TAP block with liposomal bupivacaine and bupivacaine

injecting the mixture of bupivacaine with liposomal bupivacaine in transversus abdominis plane to block the somatic nerves

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Farinaz Seifi, MD, FACOG

Role: PRINCIPAL_INVESTIGATOR

Yale University Obstetrics, Gynecology & Reproductive Sciences

Locations

Yale University

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

No NIH funding

Identifier Type: OTHER

Identifier Source: secondary_id

2000026422

Identifier Type: -

Identifier Source: org_study_id