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

NCT04226300 | Completed

• 1 other identifier: 44988
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Keywords

transversus abdominus plane; nerve block; TAP block; laparoscopic vs. ultrasound; post-op pain

Outcome Measures

Primary Outcomes (2)

• 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

  2 years

• 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.

  24 hours

Study Arms (2)

Laparoscopic-Assisted

EXPERIMENTAL

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

Procedure: Laparoscopic

Ultrasound-Guided

ACTIVE COMPARATOR

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

Procedure: Ultrasound

Interventions

Laparoscopic PROCEDURE

A transversus abdominis nerve block will be placed laparoscopically.

Laparoscopic-Assisted

Ultrasound PROCEDURE

A transversus abdominis nerve block will be place by ultrasound

Ultrasound-Guided

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients age 0-18 years who are undergoing laparoscopic surgery at Lucille Packard Children's Hospital
• Clinical indication for abdominal peripheral nerve block

You may not qualify if:

• conversion to open procedure
• allergy to local anesthetic
• multiple procedures planned with \>1 surgical specialty

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Lucille Packard Children's Hospital

Palo Alto, California, 94305, United States

Location

Related Publications (8)

• 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.

  PMID: 21154380 BACKGROUND

• 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.

  PMID: 21296242 BACKGROUND

• 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.

  PMID: 20175754 BACKGROUND

• 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.

  PMID: 22834467 BACKGROUND

• 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.

  PMID: 20802056 BACKGROUND

• 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.

  PMID: 21504934 BACKGROUND

• 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.

  PMID: 20964768 BACKGROUND

• 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.

  PMID: 28472015 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Laparoscopy; High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Stephanie Chao, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants, their families, post-anesthesia care unit nurses and anesthesiologists reviewing images of the ultrasound will be blinded to the intervention.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatric Surgery

Model Details: Patients will be randomized to receive a TAP block either by the surgeon, laparoscopically, or by the anesthesia team via ultrasound guidance.

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 13, 2020
• Study Start: July 11, 2019
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: March 19, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)