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Lap-assisted vs. US-Guided Visualization of TAP Blocks (LUV-TAP)

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Laparoscopic
Ultrasound
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pain, Postoperative focused on measuring transversus abdominus plane, nerve block, TAP block, laparoscopic vs. ultrasound, post-op pain

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Lucille Packard Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laparoscopic-Assisted

Ultrasound-Guided

Arm Description

Surgeons will place TAP block laparoscopically using a camera prior to beginning a surgical procedure.

Anesthesiologists will use ultrasound to place TAP block prior to beginning a surgical procedure.

Outcomes

Primary Outcome Measures

Transversus abdominis plane (TAP) block location
Images of the TAP block will be taken and reviewed by anesthesiologists to document the location of the block
Post-operative pain
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 Outcome Measures

Full Information

First Posted
January 9, 2020
Last Updated
March 17, 2021
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT04226300
Brief Title
Lap-assisted vs. US-Guided Visualization of TAP Blocks
Acronym
LUV-TAP
Official Title
Laparoscopic-Assisted Versus Ultrasound-Guided Visualization of Transversus Abdominis Plane Blocks
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
July 11, 2019 (Actual)
Primary Completion Date
February 28, 2021 (Actual)
Study Completion Date
February 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
transversus abdominus plane, nerve block, TAP block, laparoscopic vs. ultrasound, post-op pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized to receive a TAP block either by the surgeon, laparoscopically, or by the anesthesia team via ultrasound guidance.
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Participants, their families, post-anesthesia care unit nurses and anesthesiologists reviewing images of the ultrasound will be blinded to the intervention.
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic-Assisted
Arm Type
Experimental
Arm Description
Surgeons will place TAP block laparoscopically using a camera prior to beginning a surgical procedure.
Arm Title
Ultrasound-Guided
Arm Type
Active Comparator
Arm Description
Anesthesiologists will use ultrasound to place TAP block prior to beginning a surgical procedure.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic
Intervention Description
A transversus abdominis nerve block will be placed laparoscopically.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound
Intervention Description
A transversus abdominis nerve block will be place by ultrasound
Primary Outcome Measure Information:
Title
Transversus abdominis plane (TAP) block location
Description
Images of the TAP block will be taken and reviewed by anesthesiologists to document the location of the block
Time Frame
2 years
Title
Post-operative pain
Description
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.
Time Frame
24 hours

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Chao, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lucille Packard Children's Hospital
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21154380
Citation
Charlton S, Cyna AM, Middleton P, Griffiths JD. Perioperative transversus abdominis plane (TAP) blocks for analgesia after abdominal surgery. Cochrane Database Syst Rev. 2010 Dec 8;(12):CD007705. doi: 10.1002/14651858.CD007705.pub2.
Results Reference
background
PubMed Identifier
21296242
Citation
Siddiqui MR, Sajid MS, Uncles DR, Cheek L, Baig MK. A meta-analysis on the clinical effectiveness of transversus abdominis plane block. J Clin Anesth. 2011 Feb;23(1):7-14. doi: 10.1016/j.jclinane.2010.05.008.
Results Reference
background
PubMed Identifier
20175754
Citation
Petersen PL, Mathiesen O, Torup H, Dahl JB. The transversus abdominis plane block: a valuable option for postoperative analgesia? A topical review. Acta Anaesthesiol Scand. 2010 May;54(5):529-35. doi: 10.1111/j.1399-6576.2010.02215.x. Epub 2010 Feb 17.
Results Reference
background
PubMed Identifier
22834467
Citation
Mai CL, Young MJ, Quraishi SA. Clinical implications of the transversus abdominis plane block in pediatric anesthesia. Paediatr Anaesth. 2012 Sep;22(9):831-40. doi: 10.1111/j.1460-9592.2012.03916.x.
Results Reference
background
PubMed Identifier
20802056
Citation
Carney J, Finnerty O, Rauf J, Curley G, McDonnell JG, Laffey JG. Ipsilateral transversus abdominis plane block provides effective analgesia after appendectomy in children: a randomized controlled trial. Anesth Analg. 2010 Oct;111(4):998-1003. doi: 10.1213/ANE.0b013e3181ee7bba. Epub 2010 Aug 27.
Results Reference
background
PubMed Identifier
21504934
Citation
Sandeman DJ, Bennett M, Dilley AV, Perczuk A, Lim S, Kelly KJ. Ultrasound-guided transversus abdominis plane blocks for laparoscopic appendicectomy in children: a prospective randomized trial. Br J Anaesth. 2011 Jun;106(6):882-6. doi: 10.1093/bja/aer069. Epub 2011 Apr 18.
Results Reference
background
PubMed Identifier
20964768
Citation
Fredrickson MJ, Paine C, Hamill J. Improved analgesia with the ilioinguinal block compared to the transversus abdominis plane block after pediatric inguinal surgery: a prospective randomized trial. Paediatr Anaesth. 2010 Nov;20(11):1022-7. doi: 10.1111/j.1460-9592.2010.03432.x.
Results Reference
background
PubMed Identifier
28472015
Citation
Ravichandran NT, Sistla SC, Kundra P, Ali SM, Dhanapal B, Galidevara I. Laparoscopic-assisted Tranversus Abdominis Plane (TAP) Block Versus Ultrasonography-guided Transversus Abdominis Plane Block in Postlaparoscopic Cholecystectomy Pain Relief: Randomized Controlled Trial. Surg Laparosc Endosc Percutan Tech. 2017 Aug;27(4):228-232. doi: 10.1097/SLE.0000000000000405.
Results Reference
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Lap-assisted vs. US-Guided Visualization of TAP Blocks

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