The Minimal Effective Volume (MEV90) of Ropivacaine 0.75% for Ultrasound-guided Transmuscular Quadratus Lumborum Block

Percutaneous Nephrolithotomy Clinical Trial

Official title:

The Minimal Effective Volume (MEV90) of Ropivacaine 0.75% for Ultrasound-guided Transmuscular Quadratus Lumborum Block for Unilateral Percutaneous Nephrolitotomy: a Study Protocol for a Dose Finding Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04196270
• Other study ID #: Clinical Trials Zealand
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: January 5, 2020
• Est. completion date: November 1, 2020

Study information

• Verified date: December 2019
• Source: Zealand University Hospital
• Contact: Jens B Børglum, PhD
• Phone: +4530700120
• Email: jens.borglum[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This double-blind dose-finding trial is based on a biased coin up-and-down sequential design, where the volume of local anesthetic administered to each patient depends on the response from the previous one. The TQL block is performed preoperatively, and the first patient recruited receives 20 mL of ropivacaine 0.75%. In case of block failure, the next patient will receive a higher volume (defined as the previous volume with an increment of 2 mL). Given a successful block for the first patient, the next patient will be randomized to either a lower volume (defined as the previous volume with a reduction of 2 mL) or the same volume as the previous patient. The respective probabilities being b=0.11 for a reduced volume and 1-b=0.89 for the same volume. Block success is defined as patient reported numeric rated scale (NRS) pain (NRS value ≤ 3 (0-10/10)), 30 minutes after arrival in the post anesthesia care unit (PACU). The NRS pain value is our primary and only outcome in the evaluation of the block. A minimum of 25 eligible patients are needed to achieve precise estimation of MEV90 with narrow 95% confidence intervals derived by bootstrapping. Following inclusion of 25 patients early termination is considered when interim analysis shows sufficiently stabilization of MEV90 estimate. The final sample size is not known a priori, but a maximum of 40 patients will be enrolled in the trial.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: November 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients eligible for the trail must comply with all of the following requirements to be included:

• Scheduled for elective PNL surgery in general anesthesia with propofol and remifentanil

• Age > 18 years at the date of inclusion

• Have received thorough information, oral and written, and signed the "informed consent" form on participation in the trail

• ASA score 1-3

Exclusion Criteria:

• Inability to speak and understand Danish

• Allergy to local anesthetics or opioids

• Daily intake of opioids (evaluated by the investigators)

• Drug and/or substance abuse

• Local infection at the site of injection or systemic infection

• Difficult visualization of muscular and fascial structures necessary for successful block administration

• Pregnancy or breastfeeding

Related Conditions & MeSH terms

• Percutaneous Nephrolithotomy

Intervention

Drug:
• Ropivacaine injection
In a dose finding study the total volume of ropivacaine changes according to the biased coin up-and-down sequential design

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zealand University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric rated scale	Pain score from numeric rated scale 0-10/10 Pain score, numeric rated scale 0-10/10. 0=no pain, 10=maximum pain	30 minutes after arrival in the post anesthesia care unit