Ultrasound-guided Transmuscular Quadratus Lumborum Block for Percutaneous Nephrolithotomy

Kidney Stone Clinical Trial

Official title:

Ultrasound-guided Transmuscular Quadratus Lumborum Block for Elective Percutaneous Nephrolithotomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02818140
• Other study ID #: 2015-004770-16
• Status: Completed
• Phase: Phase 4
• First received: June 27, 2016
• Last updated: March 21, 2018
• Start date: July 2016
• Est. completion date: March 2018

Study information

• Verified date: March 2018
• Source: Zealand University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stone
• Nephrolithiasis

Intervention

Procedure:
• Ropivacaine TQL block
Unilateral ultrasound-guided TQL block with 30 mL ropivacaine 0.75% 30 min prior to the surgical procedure
• Saline TQL block
Unilateral ultrasound-guided TQL block with 30 mL of saline 0,9% 30 min prior to the surgical procedure

Drug:
• Ropivacaine

• Saline

Device:
• Ultrasound

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zealand University Hospital

References & Publications (2)

Dam M, Hansen CK, Børglum 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. — View Citation

Hansen CK, Dam M, Bendtsen TF, Børglum 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total morphine consumption	Morphine consumption in the first 6 hours postoperatively - data from PCA pump and patient medical record	6 hours postoperatively
Secondary	Total morphine consumption	Data from PCA pump and patient electronic file	15 min, 30 min, 1 h, 2h, 4h, 6h, 12h, 18h, 24 hours postoperatively
Secondary	Pain score at rest (NRS 0-10/10)	Pain score NRS	15 min, 30 min, 1 h, 2h, 4h, 6h, 12h, 18h, 24 hours postoperatively
Secondary	Pain score at sitting position (NRS 0-10/10)	Pain score NRS	15 min, 30 min, 1 h, 2h, 4h, 6h, 12h, 18h, 24 hours postoperatively
Secondary	Time to first ambulation - get out of bed	Time to first ambulation from bed to walk on the floor	0-24 hours postoperatively
Secondary	Opioid side effects (nausea, vomiting)	PONV, number of episodes, antiemetics	0-24 hours postoperatively
Secondary	NRS score during application of the TQL block (NRS 0-10/10)	Procedure discomfort	intraoperative