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Laparoscopic vs Ultrasound Guided TAP Block in Colorectal Surgery. A Randomised Controlled Study.

NCT04907461 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2024-02-01

No results posted yet for this study

Summary

A randomized clinical trial aiming to compare two different techniques of performing a nerve blockage of the abdominal wall. When performing surgery on the colon and rectum surgeons often use a minimal invasive technique called Laparoscopic surgery. In this technique small incisions in the abdominal wall are used to put special ports trough into the abdomen so that surgical instrument can be inserted. To minimize the pain caused by these port-holes, a so-called Transversus Abdominus Plane (TAP) nerve block is performed directly after the surgery before the patient wakes up from narcosis.

This procedure is normally performed by the anesthesiologist using ultrasound to guide a needle to the right depth or "plane" in the abdominal wall where the nerves are gathered. When in the right position a local anesthetic is injected that will block the nerves and thereby anaesthetizing the abdominal wall for the first post-operative day.

Recently an alternative way of guiding the needle to the right position has been presented. By using a laparoscopic camera the surgeon can easily guide the needle and inject the local anesthetics during surgery. This way of performing the TAP block may save valuable time compared to the more cumbersome ultrasound guided technique while also not needing an extra anesthesiologist in the operating theater.

In this study we aim to include participants selected for elective minimal invasive surgery of the colon or rectum, where a TAP block is normally performed. The participant will be randomized to either a TAP block performed by the surgeon using laparoscopic guidance or by an anesthesiologist using ultrasound guidance. The intended surgery in itself will not be altered.

During surgery we will measure TAP procedure time, total surgical time, total duration of anesthesia and total time spent in the operating theater. The following 2 postoperative days we will measure experienced pain using a validated pain-score (VAS) and measure the total consumption of pain medication. 2 days after surgery the study ends for the participant and there is no further follow up.

By conducting this study we can determine whether a laparoscopic guided TAP by the surgeon, compared to a traditional ultrasound guided by the anesthesiologist; gives a shorter procedure time, shorter time of narcosis and reduced consumption of pain medications post-operative while still not affecting the experienced pain by the participant.

Conditions

  • Laparoscopic Surgical Procedure
  • Nerve Block

Interventions

PROCEDURE

LAPTAP

Laparoscopic guided Transverse Abdominus Plane block

Sponsors & Collaborators

  • Danderyd Hospital

    lead OTHER

Principal Investigators

  • Klas Pekkari, PhD, MD · Danderyds Hospital, Karolinska Institute

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-31
Primary Completion
2023-05-20
Completion
2023-07-24

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04907461 on ClinicalTrials.gov