Transmuscular Quadratus Lumborum Block for Laparoscopic Cholecystectomy

Pain Clinical Trial

— TQL  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02225418
• Other study ID #: BBH-TQL-LC
• Secondary ID: 2013-001364-30
• Status: Withdrawn
• Phase: N/A
• First received: January 28, 2014
• Last updated: July 20, 2015
• Start date: November 2014

Study information

• Verified date: July 2015
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines AuthorityDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholecystitis
• Pain

Intervention

Drug:
• Ropivacaine

• saline

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Jens Borglum Neimann	Department of Surgery Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score in sitting position	Numerical Rating Scale (NRS) score 1 hour after administration of TQL block	1 hour	No
Secondary	Pain score at rest	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	No
Secondary	Pain score at sitting position	NRS score after administration of TQL block at said time points	15 min 30 min 2 hour 3 hour 4 hour 5 hour	No
Secondary	Total opioid consumption in PACU area	During stay in PACU area	On average 3 hours	No
Secondary	Opioid side effects (nausea, vomiting)	During stay in PACU area	On average 3 hours	No
Secondary	Length of stay in PACU area	Total time in PACU area	On average 3 hours	No