Transmuscular Quadratus Lumborum Block for Laparoscopic Cholecystectomy

Not Applicable

Withdrawn

• Conditions: Cholecystitis; Pain
• Interventions: Drug: saline; Drug: Ropivacaine

• Registration Number: NCT02225418
• Lead Sponsor: Jens Borglum Neimann

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-28
• Study First Submitted QC: 2014-08-25
• Study First Posted: 2014-08-26
• Study Start: 2014-11
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-20
• Last Update Posted: 2015-07-22
• Primary Completion: 2015-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo TQL block	saline	30 ml single shot TQL block with saline 0,9%
Active TQL block	Ropivacaine	30 ml single shot TQL block with ropivacaine 0,75%

Primary Outcome Measures

Name	Time	Method
Pain score in sitting position	1 hour	Numerical Rating Scale (NRS) score 1 hour after administration of TQL block

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark