Laparoscopic-Assisted Versus Ultrasound-Guided Visualization of Transversus Abdominis Plane Blocks
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Stanford University
- Enrollment
- 116
- Locations
- 1
- Primary Endpoint
- Transversus abdominis plane (TAP) block location
Study Overview
Brief Summary
Peripheral nerve blocks have been effective in decreasing post-operative pain as well as the use of narcotics for numerous years. Typically, these blocks are placed by anesthesiologist via ultrasound. In more recent years, surgeons have been placing nerve blocks laparoscopically. Since there are few studies that looks compare the two techniques we aim to perform a randomized control trial to demonstrate if a laparoscopic placed nerve block is as efficient and accurate as an ultrasound placed block.
Detailed Description
Ultrasound-guided peripheral nerve blocks like the transversus abdominis plane (TAP) block are useful for post-operative pain control and reducing opioid analgesics.(1-3) A recent meta-analysis of TAP blocks in adults demonstrated a reduction in post-operative opioid requirements, and improved pain scores.(2) Within the pediatric population, numerous other studies have confirmed the benefit of TAP blocks and their ability to lower pain scores, reduce opioid use and opioid-related side effects post-operatively.(4) While there have been many prospective randomized trials for ultrasound-guided TAP blocks (5-7), there has been limited evaluation of surgically-placed TAP blocks (8). There has been no published data evaluating or comparing surgically placed TAP blocks in pediatric patients undergoing laparoscopic procedures. placed TAP blocks in pediatrics have not been examined in patients undergoing laparoscopic procedures.(4) Our pilot study was designed as a proof of concept, to demonstrate that ultrasound images could be used to verify the distribution of local anesthetic after a laparoscopically-assisted TAP block. The aim of this study is to continue using ultrasound to verify the location of laparoscopic-assisted TAP blocks, and compare the post-operative outcomes (pain scores, opioid use, etc.) to those who receive ultrasound-guided TAP blocks. We plan to do this in a prospective, randomized and semi-blinded fashion.
We hypothesize that (1) we will be able to accurately describe the location of the TAP block placed by both methods in more than 90% of cases; (2) laparoscopic-assisted TAP blocks will be as effective as ultrasound-guided TAP blocks in terms of managing/reducing post-operative pain scores and reducing the amount and frequency of postoperative opioid analgesia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description
Participants, their families, post-anesthesia care unit nurses and anesthesiologists reviewing images of the ultrasound will be blinded to the intervention.
Eligibility Criteria
- Ages
- — to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients age 0-18 years who are undergoing laparoscopic surgery at Lucille Packard Children's Hospital
- •Clinical indication for abdominal peripheral nerve block
Exclusion Criteria
- •conversion to open procedure
- •allergy to local anesthetic
- •multiple procedures planned with >1 surgical specialty
Arms & Interventions
Laparoscopic-Assisted
Surgeons will place TAP block laparoscopically using a camera prior to beginning a surgical procedure.
Intervention: Laparoscopic (Procedure)
Ultrasound-Guided
Anesthesiologists will use ultrasound to place TAP block prior to beginning a surgical procedure.
Intervention: Ultrasound (Procedure)
Outcomes
Primary Outcomes
Transversus abdominis plane (TAP) block location
Time Frame: 2 years
Images of the TAP block will be taken and reviewed by anesthesiologists to document the location of the block
Post-operative pain
Time Frame: 24 hours
The Face Pain Scale (Hicks et. al., 2001) is a self-reported scale that uses cartoon depictions of faces to quantify on a scale 0-10 scale how pain a child is experiencing at a given moment.
Secondary Outcomes
No secondary outcomes reported
Investigators
Stephanie D. Chao
Assistant Professor of Pediatric Surgery
Stanford University