Ultrasound-guided Transmuscular Quadratus Lumborum Block for Percutaneous Nephrolithotomy

Zealand University Hospital

Status and phase: Completed; Phase 4

Conditions: Kidney Stone

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02818140

2015-004770-16

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Ropivacaine TQL block

Active Comparator group

Description:

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

Treatment:

Device: Ultrasound

Drug: Ropivacaine

Procedure: Ropivacaine TQL block

Placebo TQL block

Placebo Comparator group

Description:

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

Treatment:

Procedure: Saline TQL block

Device: Ultrasound

Drug: Saline