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Completed

NCT Number: NCT02818140

Ultrasound-guided Transmuscular Quadratus Lumborum Block for Percutaneous Nephrolithotomy

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

Patients undergoing percutaneous nephrolithotomy (PNL) suffer from acute postoperative pain, despite a multimodal analgesic regime, and the patients receive considerable amounts of long lasting opioids. For the patients this greatly increase the risk of experiencing the adverse effects of opioids.

The ultrasound-guided (USG) transmuscular quadratus lumborum (TQL) block is a single dosage of local anesthetic (LA) delivered in the plane between the psoas major muscle and the quadratus lumborum muscle. LA spreads cephalad into the thoracic paravertebral space to reach the somatic ventral rami (intercostal nerves) and the thoracic sympathetic trunk. The TQL block can reduce visceral pain and pain originating from the abdominal wall and has an expected duration of analgesic efficacy of 24 hours.

The aim of this study is to investigate the efficacy of the active USG TQL block together with the multimodal analgesic regime to reduce postoperative opioid consumption and pain compared to placebo USG TQL block and the multimodal analgesic regime in a randomized and placebo controlled design.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

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Treatment and study plan

Ropivacaine TQL block

Procedure

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

Other names: Naropin

Saline TQL block

Procedure

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

Ropivacaine

Drug

Saline

Drug

Ultrasound

Device

Primary outcomes

  1. Total morphine consumption

    Time frame: 6 hours postoperatively

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

Secondary outcomes

  1. Total morphine consumption

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

    Data from PCA pump and patient electronic file

  2. Pain score at rest (NRS 0-10/10)

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

    Pain score NRS

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

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

    Pain score NRS

  4. Time to first ambulation - get out of bed

    Time frame: 0-24 hours postoperatively

    Time to first ambulation from bed to walk on the floor

  5. Opioid side effects (nausea, vomiting)

    Time frame: 0-24 hours postoperatively

    PONV, number of episodes, antiemetics

  6. NRS score during application of the TQL block (NRS 0-10/10)

    Time frame: intraoperative

    Procedure discomfort

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Registry information

Official study title

Ultrasound-guided Transmuscular Quadratus Lumborum Block for Elective Percutaneous Nephrolithotomy

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 29, 2016
Registry last updated
Mar 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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