Ultrasound-guided Transmuscular Quadratus Lumborum Block for Percutaneous Nephrolithotomy

NCT02818140 | Completed Phase 4 DMC

• 1 other identifier: 2015-004770-16
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patients undergoing percutaneous nephrolithotomy (PNL) suffer from acute postoperative pain, despite a multimodal analgesic regime. We hypothesize that active (ropivacaine) transmuscular quadratus lumborum (TQL) block will significantly reduce postoperative opioid consumption and pain following PNL operation compared with placebo (saline) TQL block. The aim of this study is to investigate the effect of ultrasound-guided (USG) TQL block concurrent with a multimodal analgesic regime compared to the multimodal analgesic regime alone (and placebo TQL block) in a randomized and placebo controlled design.

Conditions

Kidney Stone

Keywords

Postoperative pain; Transmuscular quadratus lumborum block; Block; Ropivacaine; TQL; percutaneous nephrolithotomy; PNL; Ultrasound-guided

Outcome Measures

Primary Outcomes (1)

• Total morphine consumption

  Morphine consumption in the first 6 hours postoperatively - data from PCA pump and patient medical record

  6 hours postoperatively

Secondary Outcomes (6)

• Total morphine consumption

  15 min, 30 min, 1 h, 2h, 4h, 6h, 12h, 18h, 24 hours postoperatively

• Pain score at rest (NRS 0-10/10)

  15 min, 30 min, 1 h, 2h, 4h, 6h, 12h, 18h, 24 hours postoperatively

• Pain score at sitting position (NRS 0-10/10)

  15 min, 30 min, 1 h, 2h, 4h, 6h, 12h, 18h, 24 hours postoperatively

• Time to first ambulation - get out of bed

  0-24 hours postoperatively

• Opioid side effects (nausea, vomiting)

  0-24 hours postoperatively

Study Arms (2)

Ropivacaine TQL block

ACTIVE COMPARATOR

Unilateral single shot ultrasound-guided TQL block with 30 ml of ropivacaine 0.75%

Procedure: Ropivacaine TQL block; Drug: Ropivacaine; Device: Ultrasound

Placebo TQL block

PLACEBO COMPARATOR

Unilateral single shot ultrasound-guided TQL block with 30 ml saline 0.9%

Procedure: Saline TQL block; Drug: Saline; Device: Ultrasound

Interventions

Ropivacaine TQL block PROCEDURE

Unilateral ultrasound-guided TQL block with 30 mL ropivacaine 0.75% 30 min prior to the surgical procedure

Also known as: Naropin

Ropivacaine TQL block

Saline TQL block PROCEDURE

Unilateral ultrasound-guided TQL block with 30 mL of saline 0,9% 30 min prior to the surgical procedure

Placebo TQL block

Ropivacaine DRUG

Ropivacaine TQL block

Saline DRUG

Placebo TQL block

Ultrasound DEVICE

Placebo TQL block; Ropivacaine 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 PNL operation in general anaesthesia with propofol and remifentanil.
• Received oral and written information about the trial Signed the informed consent American Society of Anesthesiologists (ASA) classification 1-3

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 or drug abuse Difficulty or inability to visualize the relevant muscular or fascial structures necessary to perform the USG-TQL block Pregnancy

Sponsors & Collaborators

• Zealand University Hospital: lead

Related Publications (3)

• Hansen CK, Dam M, Bendtsen TF, Borglum J. Ultrasound-Guided Quadratus Lumborum Blocks: Definition of the Clinical Relevant Endpoint of Injection and the Safest Approach. A A Case Rep. 2016 Jan 15;6(2):39. doi: 10.1213/XAA.0000000000000270. No abstract available.

  PMID: 26771297 BACKGROUND

• Dam M, Hansen CK, Borglum J, Chan V, Bendtsen TF. A transverse oblique approach to the transmuscular Quadratus Lumborum block. Anaesthesia. 2016 May;71(5):603-4. doi: 10.1111/anae.13453. No abstract available.

  PMID: 27072772 BACKGROUND

• Dam M, Hansen CK, Poulsen TD, Azawi NH, Wolmarans M, Chan V, Laier GH, Bendtsen TF, Borglum J. Transmuscular quadratus lumborum block for percutaneous nephrolithotomy reduces opioid consumption and speeds ambulation and discharge from hospital: a single centre randomised controlled trial. Br J Anaesth. 2019 Aug;123(2):e350-e358. doi: 10.1016/j.bja.2019.04.054. Epub 2019 May 30.

  PMID: 31153628 DERIVED

MeSH Terms

Conditions

Kidney Calculi; Pain, Postoperative; Bites and Stings

Interventions

Ropivacaine; Sodium Chloride; Ultrasonography

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Mette Dam, MD, PhD Fellow

  Zealand University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: June 29, 2016
• Study Start: July 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: March 22, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share