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Pain, PostoperativeLUV-TAPNCT04226300

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

A study testing Laparoscopic and Ultrasound in people with Pain, Postoperative, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 18 yearsHealthy volunteers can take part
Conditions the study is for
Pain, Postoperative
What is being tested?
Laparoscopic and Ultrasound
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
1 siteUnited States
Study dates
11 Jul 2019to 28 Feb 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Lucille Packard Children's Hospital

    Palo Alto, California, 94305

Other trials in United States

About this study

Official title: Laparoscopic-Assisted Versus Ultrasound-Guided Visualization of Transversus Abdominis Plane Blocks

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.

Read the 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.

Being tested
Laparoscopic, Ultrasound
Keywords
transversus abdominus plane, nerve block, TAP block, laparoscopic vs. ultrasound, post-op pain
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LaparoscopicProcedure or surgery

    A transversus abdominis nerve block will be placed laparoscopically.

  • UltrasoundProcedure or surgery

    A transversus abdominis nerve block will be place by ultrasound

Study groups in NCT04226300
Study groupRoleWhat they receive
Laparoscopic-AssistedExperimentalSurgeons will place TAP block laparoscopically using a camera prior to beginning a surgical procedure.
Receives: Procedure: Laparoscopic
Ultrasound-GuidedActive comparatorAnesthesiologists will use ultrasound to place TAP block prior to beginning a surgical procedure.
Receives: Procedure: Ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 2 years

  2. 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.

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2020
  2. Study start11 Jul 2019
  3. Primary completion28 Feb 2021
  4. Study completion28 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
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
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04226300
Sponsor's protocol ID
44988
Acronym
LUV-TAP
Status last verified
Mar 2021
First submitted
9 Jan 2020
Last updated
19 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21154380

  • 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.

    PubMed 21296242

  • 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.

    PubMed 20175754

  • 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.

    PubMed 22834467

  • 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.

    PubMed 20802056

  • 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.

    PubMed 21504934

  • 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.

    PubMed 20964768

  • 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.

    PubMed 28472015

Questions about this trial

What is this clinical trial studying?

A study testing Laparoscopic and Ultrasound in people with Pain, Postoperative, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Transversus abdominis plane (TAP) block location (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04226300, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2021.

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