Optimizing an applied ultrasound-guided block for pain management in patients undergoing kidneystone surgery.

The minimal effective volume (MEV90) of ropivacaine 0.75 % for ultrasound-guided transmuscular quadratus lumborum block for unilateral percutaneous nephrolitotomy – A dose finding study.

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-002200-40-DK

Enrollment

Registered

2019-05-28

Start date

2019-07-04

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative pain following percutaneous nephrolithotomy. MedDRA version: 20.0 Level: LLT Classification code 10059805 Term: Nephrolithotomy System Organ Class: 100000004865

Interventions

Trade Name: Ropivacaine Product Name: Ropivacaine Pharmaceutical Form: Injection INN or Proposed INN: Ropivacaine Other descriptive nam

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: Inability to cooperate 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 Difficulty visualization of muscular and fascial structures in ultrasound visualization necessary to the block administration Substantial co-morbidity, ASA >3 Pregnant or breastfeeding

Design outcomes

Primary

Measure	Time frame
Secondary Objective: Not applicable. ;Primary end point(s): Pain intensity (NRS 0-10/10) measured 30 minutes after arrival to the Post-Anesthesia Care Unit will be our primary and only effect parameter to evaluate whether the administered volume resulted in block success or failure. ;Timepoint(s) of evaluation of this end point: 30 minutes after arrival to the Post-Anesthesia Care Unit (PACU). ;Main Objective: We aim to optimize an opioid sparing regional anesthetic technique by optimizing the peripheral nerve blockade dosage, thus reducing both ORADEs as well as minimizing the amount of local anesthetic administered. The TQL block has been shown to exert a significant positive effect on postoperative pain management following PNL surgery administering 30 ml of ropivacaine 0.75% with a unilateral TQL block. We want to investigate whether it was possible to reduce the volume of local anesthetic administered to minimize the risk of local anesthetic systemic toxicity (LAST), and still have maximum beneficial clinical efficacy. Therefore, we wish to conduct a biased coin up-and-down sequential design to direct estimation of the minimum effective volume (MEV90) of ropivacaine 0.75% in 90% of patients undergoing unilateral PNL surgery.	—

Measure

Time frame

Secondary Objective: Not applicable. ;Primary end point(s): Pain intensity (NRS 0-10/10) measured 30 minutes after arrival to the Post-Anesthesia Care Unit will be our primary and only effect parameter to evaluate whether the administered volume resulted in block success or failure. ;Timepoint(s) of evaluation of this end point: 30 minutes after arrival to the Post-Anesthesia Care Unit (PACU). ;Main Objective: We aim to optimize an opioid sparing regional anesthetic technique by optimizing the peripheral nerve blockade dosage, thus reducing both ORADEs as well as minimizing the amount of local anesthetic administered. The TQL block has been shown to exert a significant positive effect on postoperative pain management following PNL surgery administering 30 ml of ropivacaine 0.75% with a unilateral TQL block. We want to investigate whether it was possible to reduce the volume of local anesthetic administered to minimize the risk of local anesthetic systemic toxicity (LAST), and still have maximum beneficial clinical efficacy. Therefore, we wish to conduct a biased coin up-and-down sequential design to direct estimation of the minimum effective volume (MEV90) of ropivacaine 0.75% in 90% of patients undergoing unilateral PNL surgery.

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Secondary

Measure	Time frame
Secondary end point(s): Not applicable ;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Denmark

Contacts

Public ContactJens Børglum

Department of Anaesthesiology and Intensive Care Medicine, Zealand University Hospital, Roskilde

jens.borglum@gmail.com+4530700120

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026