Efficacy of Transversus Abdominis Plane Block

NCT06274307 | Completed DMC

• 1 other identifier: IRB-21-10-4045
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to assess the efficacy of Transversus Abdominus Plane (TAP) blocks, a well-established anesthetic technique, to decrease the amount of post-operative pain in patients who undergo minimally invasive gynecologic surgeries. During minimally invasive gynecologic surgeries, the abdomen is inflated with pressurized air for visualization purposes and released at the end of the surgery. Traditionally, TAP blocks are performed by injecting long-acting local anesthetic agents under ultrasound guidance into the abdominal wall after abdominal surgery after the air has been emptied from the abdomen for additional anesthetic coverage post-operatively. This study proposes a novel approach: that performing TAP blocks while the abdomen is still insufflated will result in better post-operative pain outcomes as compared to the traditional method.

Conditions

Anesthesia, Local

Keywords

Transversus abdominal-plane block; Pain managment; Ultrasound

Outcome Measures

Primary Outcomes (11)

• Time to perform TAP Block

  Time taken to successfully perform the TAP block. Defined as the time from initial placement of ultrasound probe on the skin to the completion of the block on the contralateral side.

  Within 10 minutes of starting procedure.

• TAP block attempts

  The number of attempts taken to sucessfully perform the TAP block.

  Within 10 minutes of starting procedure.

• Pain Score Visual Analog Scale (VAS) 0 Hours Post Surgery

  Pain score on an 11-point (0 - no pain to 10 - worst imaginable pain) Visual Analog Scale (VAS) at rest

  0 hours following TAP block]

• Pain Score Visual Analog Scale (VAS) 1 Hours Post Surgery

  Pain score on an 11-point (0 - no pain to 10 - worst imaginable pain) Visual Analog Scale (VAS) at rest

  1 hour following TAP block]

• Pain Score Visual Analog Scale (VAS) 2 Hours Post Surgery

  Pain score on an 11-point (0 - no pain to 10 - worst imaginable pain) Visual Analog Scale (VAS) at rest

  2 hours following TAP block]

• Pain Score Visual Analog Scale (VAS) 4 Hours Post Surgery

  Pain score on an 11-point (0 - no pain to 10 - worst imaginable pain) Visual Analog Scale (VAS) at rest

  4 hours following TAP block]

• Pain Score Visual Analog Scale (VAS) 24 Hours Post Surgery

  Pain score on an 11-point (0 - no pain to 10 - worst imaginable pain) Visual Analog Scale (VAS) at rest

  24 hours following TAP block]

• Postoperative Opioid Consumption

  Patient opioid consumption in the 24 hours post TAP block

  24 hours post operative period

• Ease of performing TAP Block-anatomical plane visualization

  The anatomical planes were clearly visualized and identified. Survey of operator - Likert Score

  Within 10 minutes of starting procedure

• Ease of performing TAP Block-performance efficacy

  The approach optimized the efficacy of the block. Survey of operator- Likert score

  Within 10 minutes of starting procedure

• Patient satisfaction

  Patient satisfaction with analgesia score (0 to 100%)

  24-hours post operative period

Study Arms (2)

Active Comparator: Transversus abdominis plane (TAP) block performed in operating room

ACTIVE COMPARATOR

The treatment group will have a transversus abdominis plane (TAP) block performed prior to closing surgical port sites post-operatively in an insufflated abdomen in the operating room (OR). The local anesthetic used for the TAP block will be 30 to 40ml of Ropivacaine 0.375%, not to exceed a max dose of 3mg/kg of 0.375% divided equally bilaterally. Each study participant will receive standard post-operative pain medication orders of morphine 2mg q5mins times 4 doses followed by hydromorphone. 0.5mg q10mins times 4 doses.

Procedure: Transversus abdominis plane block

Transversus abdominis plane (TAP) block performed in PACU

ACTIVE COMPARATOR

The treatment group will have a transversus abdominis plane (TAP) block performed post-operatively after the patient has been transferred from the Operating Room to the Post Anesthesia Care Unit (PACU). The local anesthetic used for the TAP block will be 30 to 40ml of Ropivacaine 0.375%, not to exceed a max dose of 3mg/kg of 0.375% divided equally bilaterally. Each study participant will receive standard post-operative pain medication orders of morphine 2mg q5mins times 4 doses followed by hydromorphone. 0.5mg q10mins times 4 doses

Procedure: Transversus abdominis plane block

Interventions

Transversus abdominis plane block PROCEDURE

A transversus abdominis plane block (TAP) block using a long-acting local anesthetic is used to manage pain during the intermediate (12-24hr) post-operative period following laparoscopic abdominal surgeries. Drug: The local anesthetic to be used in this specific intervention will be 30 to 40ml of Ropivacaine 0.375%, not to exceed a max dose of 3mg/kg of 0.375% and divided equally bilaterally.

Active Comparator: Transversus abdominis plane (TAP) block performed in operating room; Transversus abdominis plane (TAP) block performed in PACU

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female gynecological patients between 18 years and 85 years consented and scheduled for an obstetrics/gynecology laparoscopic procedure.
• Consent received to receive a TAP block.

You may not qualify if:

• Patients who are not proficient in the English language or cannot consent
• Patients who have an allergy to local anesthetics (amides)
• Patients with subcutaneous emphysema
• Patients whose surgical procedures require incisions above the umbilicus

Sponsors & Collaborators

• Justin Hruska: lead

Study Sites (2)

Detroit Medical Center Detroit Receiving Hospital

Detroit, Michigan, 48201, United States

Location

Detroit Medical Center, Harper University Hospital

Detroit, Michigan, 48201, United States

Location

Study Officials

• Justin Hruska, MD

  Wayne State University/Detroit Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patient will be unaware of their grouping allotment. The outcomes assessor will be unaware of the patient grouping allotment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The treatment group (Group 1) will have a transversus abdominis plane (TAP) block performed with an insufflated abdomen in the operating room. The control group (Group 2) will receive the traditionally performed standard of care TAP block performed in the post-anesthesia care unit

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 23, 2024
• Study Start: June 22, 2023
• Primary Completion: January 1, 2025
• Study Completion: March 1, 2025
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)