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

January 31, 2024 updated by: Danderyd Hospital

Laparoscopic Guided vs Ultrasound Guided Transabdominal Plane Block in Minimal Invasive Colorectal Surgery; a Comparison Between Time of Procedure and Efficacy on Pain Relief and Postoperative Opioid Consumption.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

At Danderyds hospital in Stockholm, since 2010, we are conducting patient care according to international evidence based Enhanced Recovery After Surgery (ERAS) protocols. Within colorectal surgery Danderyds hospital has been appointed ERAS Centre of Excellence due to documented favorable clinical results and a particularly suitable infrastructure for clinical research. The protocol comprises of 24 evidence-based interventions aimed at reducing so called surgical stress and promote early recovery after surgery. All interventions are executed in the same way for all patients. Optimal post-operative pain relief constitutes one of the 24 interventions and within this section a few methods are recommended. Transversus abdominus plane (TAP) block is one of those, and have been shown to reduce post-operative pain, reduce opioid consumption and elevate mobilization after surgery.

A TAP block is performed by injecting local anesthetics into the nervous plane in between the transverse and external muscles in the abdominal wall, and thereby blocking the nerves responsible for transmitting pain from the laparoscopic holes created during surgery.

Normally this TAP blockage is performed by the anesthesiologist using ultrasound to guide the needle for injection into the right plane of the abdominal wall. A procedure that can be cumbersome and that in our hospital setting takes around 30 minutes and is executed directly after the surgery but before the patient is alleviated of narcosis.

A novel technique has recently been described to guide the needle into the right position for the TAP block. In this technique the surgeon will use the laparoscopic camera and the port holes already made during surgery to visualize the inside of the abdominal wall, and by landmarks and a specially described bulging of the peritoneum as a marker, guide the needle from the outside and inject local anesthetics into the right plane. This method described by earlier studies has a procedure time at around 5+-1 minutes and has the benefit of not needing ultrasound or any other equipment not already present for the surgical procedure.

In this study we aim to include participants selected for elective robotic-assisted or laparoscopic 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 Visual Analog Scale (VAS) and measure the total opioid consumption. 2 days after surgery the study ends for the participant and there is no further follow up.

Previous studies on this technique have shown comparable or even better pain relieving efficacy compared to the ultrasound guided technique.

By conducting this study we can determine whether a laparoscopic guided TAP by the surgeon, compared to a traditional ultrasound guided TAP 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

Study Type

Interventional

Enrollment (Actual)

175

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sweden
      • Stockholm, Sweden, 18150
        • Danderyd hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Elective laparoscopic or robot-assisted colorectal surgery.

Exclusion Criteria:

  • IBD
  • documented alcohol addiction
  • documented opioid addiction
  • unable to be assessed by Visual Analog Scale (cognitive impairment or other)
  • Allergy against the local anaesthetic used, Ropivacain.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laparoscopic guided TAP block
The surgeon uses a laparoscopic technique to visualise the peritoneum from the inside of the abdomen and guides the hypodermic needle through the abdominal wall from the outside. When the needle point is visible through the peritoneum and almost enters the abdominal cavity, the surgeon retracts the needle around 5 mm. Then by deploying a test dose of the local anaesthetics a so called "Doyle's bulge" sign can confirm the right position in the nervous plane. A dose of 20 cc 3,75 mg/ml of Ropivacain is administered on each side of the abdominal wall in the midaxillary line, just in between the crista and costal margin.
Procedure: LAPTAP
Laparoscopic guided Transverse Abdominus Plane block
Active Comparator: Ultrasound guided TAP block
The anaesthesiologist uses ultrasound to identify the nervous plane in-between the external and transverse abdominal muscles. A dose of 20 cc 3,75 mg/ml of Ropivacain is administered on each side of the abdominal wall in the midaxillary line, just in between the crista and costal margin.
Procedure: LAPTAP
Laparoscopic guided Transverse Abdominus Plane block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post operative consumption of pain medication
Time Frame: 72 hours post surgery
Difference in pain medication consumption between arms.
72 hours post surgery
Visual Analog Scale
Time Frame: 72 hours post surgery
Difference in experienced post operative pain using Visual Analog Scale (VAS) between arms. The VAS pain scale reaches from 0-10 where 0 equals No pain and 10 equals maximum pain.
72 hours post surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TAP procedure time
Time Frame: TAP procedure during surgery
Time from start to finish of the TAP block between arms.
TAP procedure during surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danderyd Hospital

Investigators

  • Study Director: Klas Pekkari, PhD, MD, Danderyds Hospital, Karolinska Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2021

Primary Completion (Actual)

May 20, 2023

Study Completion (Actual)

July 24, 2023

Study Registration Dates

First Submitted

May 25, 2021

First Submitted That Met QC Criteria

May 25, 2021

First Posted (Actual)

May 28, 2021

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

July 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • LAPTAP Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Laws in Sweden prohibits this.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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