Transmuscular Quadratus Lumborum Block for Laparoscopic Cholecystectomy

NCT02225418 | Withdrawn DMC

• 2 other identifiers: BBH-TQL-LC2013-001364-30
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholecystitis; Pain

Keywords

Laparoscopic; Cholecystectomy; Postoperative; Pain; Quadratus lumborum; Ultrasound

Outcome Measures

Primary Outcomes (1)

• Pain score in sitting position

  Numerical Rating Scale (NRS) score 1 hour after administration of TQL block

  1 hour

Secondary Outcomes (5)

• Pain score at rest

  15 min, 30 min, 1 hour 2 hour 3 hour 4 hour 5 hour

• Pain score at sitting position

  15 min 30 min 2 hour 3 hour 4 hour 5 hour

• Total opioid consumption in PACU area

  On average 3 hours

• Opioid side effects (nausea, vomiting)

  On average 3 hours

• Length of stay in PACU area

  On average 3 hours

Study Arms (2)

Placebo TQL block

SHAM COMPARATOR

30 ml single shot TQL block with saline 0,9%

Drug: saline

Active TQL block

ACTIVE COMPARATOR

30 ml single shot TQL block with ropivacaine 0,75%

Drug: Ropivacaine

Interventions

Ropivacaine DRUG

Also known as: naropin

Active TQL block

saline DRUG

Placebo TQL block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jens Borglum Neimann: lead
• Bispebjerg Hospital: collaborator

Study Sites (1)

Bispebjerg Hospital

Copenhagen, 2400 NV, Denmark

Location

MeSH Terms

Conditions

Cholecystitis; Pain

Interventions

Ropivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Jens Børglum, MD, PhD

  University Hospital Bispebjerg and Frederiksberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: January 28, 2014
• First Posted: August 26, 2014
• Study Start: November 1, 2014
• Primary Completion: November 1, 2015
• Last Updated: July 22, 2015

Record last verified: 2015-07

Locations

DK (1)