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

Sponsor

Zealand University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT04196270

Collaborator

(none)

Enrollment

Arm

9.9

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Percutaneous Nephrolithotomy	Drug: Ropivacaine injection	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Intervention Model:

Sequential Assignment

Intervention Model Description:

The biased coin up-and-down sequential design (BCD) should be considered for direct determination of higher quantiles (ED90 and ED95) which provide useful clinical knowledge. The BCD was developed in the field of pharmacology and toxicology and was formulated by Durham et al. in 1997. In the BCD, volume assignment is carried out in a sequential and interactive method, which avoids that patients are randomized to doses with toxicity risk and seeks to concentrate treatments around the suitable doses.The biased coin up-and-down sequential design (BCD) should be considered for direct determination of higher quantiles (ED90 and ED95) which provide useful clinical knowledge. The BCD was developed in the field of pharmacology and toxicology and was formulated by Durham et al. in 1997. In the BCD, volume assignment is carried out in a sequential and interactive method, which avoids that patients are randomized to doses with toxicity risk and seeks to concentrate treatments around the suitable doses.

Masking:

None (Open Label)

Masking Description:

Double-blind

Primary Purpose:

Diagnostic

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

Anticipated Study Start Date :

Jan 5, 2020

Anticipated Primary Completion Date :

Oct 1, 2020

Anticipated Study Completion Date :

Nov 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ropivacaine 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).	Drug: Ropivacaine injection In a dose finding study the total volume of ropivacaine changes according to the biased coin up-and-down sequential design Other Names: Sequential design

Arm

Intervention/Treatment

Experimental: Ropivacaine

Drug: Ropivacaine injection

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

Other Names:

Sequential design

Outcome Measures

Primary Outcome Measures

Numeric rated scale [30 minutes after arrival in the post anesthesia care unit]
Pain score from numeric rated scale 0-10/10 Pain score, numeric rated scale 0-10/10. 0=no pain, 10=maximum pain

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Zealand University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zealand University Hospital

ClinicalTrials.gov Identifier:

NCT04196270

Other Study ID Numbers:

Clinical Trials Zealand

First Posted:

Dec 12, 2019

Last Update Posted:

Dec 16, 2019

Last Verified:

Dec 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Zealand University Hospital

dose finding study

Additional relevant MeSH terms:

Ropivacaine

Study Results

No Results Posted as of Dec 16, 2019