Transmuscular Quadratus Lumborum Block for Laparoscopic Cholecystectomy (TQL)

July 20, 2015 updated by: Jens Borglum Neimann

Ultrasoundguided Transmuscular Quadratus Lumborum Block After Elective Laparoscopic Cholecystectomy. A Prospective, Randomized Clinical Trial.

The TQL block may prove a valuable method for treating postoperative pain following scopic removal of the gall bladder.

The trial will compare active TQL block versus placebo TQL block after said operation.

The hypothesis is that active TQL block significantly will reduce postoperative pain following scopic removal of the gall bladder compared with placebo TQL block.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

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 Locations

  • Denmark
      • Copenhagen, Denmark, 2400 NV
        • Bispebjerg 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • scheduled for elective laparoscopic cholecystectomy
  • received oral and written information about the trial
  • American Society of Anaethesiologists (ASA) classification 1-3
  • NRS score > 3 upon arrival at the PACU area

Exclusion Criteria:

  • Cannot cooperate
  • Does not speak or understand Danish
  • Allergy towards drugs used in the trial
  • Large daily consumption of opioids
  • Known alcohol og medicin abuse
  • Difficult or impossible by ultrasound to visualise the intended nerve/tissue structures necessary to perform block
  • Pregnancy

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Placebo TQL block
30 ml single shot TQL block with saline 0,9%
Drug: saline
Active Comparator: Active TQL block
30 ml single shot TQL block with ropivacaine 0,75%
Drug: Ropivacaine
Other Names:
  • naropin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score in sitting position
Time Frame: 1 hour
Numerical Rating Scale (NRS) score 1 hour after administration of TQL block
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score at rest
Time Frame: 15 min, 30 min, 1 hour 2 hour 3 hour 4 hour 5 hour
NRS score after administration of TQL block at said time points
15 min, 30 min, 1 hour 2 hour 3 hour 4 hour 5 hour
Pain score at sitting position
Time Frame: 15 min 30 min 2 hour 3 hour 4 hour 5 hour
NRS score after administration of TQL block at said time points
15 min 30 min 2 hour 3 hour 4 hour 5 hour
Total opioid consumption in PACU area
Time Frame: On average 3 hours
During stay in PACU area
On average 3 hours
Opioid side effects (nausea, vomiting)
Time Frame: On average 3 hours
During stay in PACU area
On average 3 hours
Length of stay in PACU area
Time Frame: On average 3 hours
Total time in PACU area
On average 3 hours

Collaborators and Investigators

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

Sponsor

Jens Borglum Neimann

Collaborators

Bispebjerg Hospital

Investigators

  • Principal Investigator: Jens Børglum, MD, PhD, Copenhagen University Hospital Bispebjerg

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

November 1, 2014

Primary Completion (Anticipated)

November 1, 2015

Study Registration Dates

First Submitted

January 28, 2014

First Submitted That Met QC Criteria

August 25, 2014

First Posted (Estimate)

August 26, 2014

Study Record Updates

Last Update Posted (Estimate)

July 22, 2015

Last Update Submitted That Met QC Criteria

July 20, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BBH-TQL-LC
  • 2013-001364-30 (EudraCT Number)

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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