Lap-assisted vs. US-Guided Visualization of TAP Blocks

NCT ID: NCT04226300

Last Updated: 2021-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-11
• Study Completion Date: 2021-02-28

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.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Laparoscopic-Assisted

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

Group Type: EXPERIMENTAL

Laparoscopic

Intervention Type: PROCEDURE

A transversus abdominis nerve block will be placed laparoscopically.

Ultrasound-Guided

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

Group Type: ACTIVE_COMPARATOR

Ultrasound

Intervention Type: PROCEDURE

A transversus abdominis nerve block will be place by ultrasound

Interventions

Laparoscopic

A transversus abdominis nerve block will be placed laparoscopically.

Intervention Type: PROCEDURE

Ultrasound

A transversus abdominis nerve block will be place by ultrasound

Intervention Type: PROCEDURE

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

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Stephanie D. Chao

Assistant Professor of Pediatric Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephanie Chao, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Lucille Packard Children's Hospital

Palo Alto, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21154380 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21296242 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20175754 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22834467 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20802056 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21504934 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20964768 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28472015 (View on PubMed)

Other Identifiers

44988

Identifier Type: -

Identifier Source: org_study_id