Ultrasound-guided Transmuscular Quadratus Lumborum Block for Percutaneous Nephrolithotomy
- Conditions
- Kidney Stone
- Interventions
- Procedure: Ropivacaine TQL blockProcedure: Saline TQL blockDrug: SalineDevice: Ultrasound
- Registration Number
- NCT02818140
- Lead Sponsor
- Zealand University Hospital
- 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ropivacaine TQL block Ultrasound Unilateral single shot ultrasound-guided TQL block with 30 ml of ropivacaine 0.75% Ropivacaine TQL block Ropivacaine TQL block Unilateral single shot ultrasound-guided TQL block with 30 ml of ropivacaine 0.75% Placebo TQL block Saline Unilateral single shot ultrasound-guided TQL block with 30 ml saline 0.9% Placebo TQL block Saline TQL block Unilateral single shot ultrasound-guided TQL block with 30 ml saline 0.9% Placebo TQL block Ultrasound Unilateral single shot ultrasound-guided TQL block with 30 ml saline 0.9% Ropivacaine TQL block Ropivacaine Unilateral single shot ultrasound-guided TQL block with 30 ml of ropivacaine 0.75%
- Primary Outcome Measures
Name Time Method Total morphine consumption 6 hours postoperatively Morphine consumption in the first 6 hours postoperatively - data from PCA pump and patient medical record
- Secondary Outcome Measures
Name Time Method Total morphine consumption 15 min, 30 min, 1 h, 2h, 4h, 6h, 12h, 18h, 24 hours postoperatively Data from PCA pump and patient electronic file
Pain score at sitting position (NRS 0-10/10) 15 min, 30 min, 1 h, 2h, 4h, 6h, 12h, 18h, 24 hours postoperatively Pain score NRS
Time to first ambulation - get out of bed 0-24 hours postoperatively Time to first ambulation from bed to walk on the floor
NRS score during application of the TQL block (NRS 0-10/10) intraoperative Procedure discomfort
Opioid side effects (nausea, vomiting) 0-24 hours postoperatively PONV, number of episodes, antiemetics
Pain score at rest (NRS 0-10/10) 15 min, 30 min, 1 h, 2h, 4h, 6h, 12h, 18h, 24 hours postoperatively Pain score NRS