Improving pain management after laparascopic surgery for kidney stones

Phase 1

Conditions: The postoperative pain after percutaneous nephrolithotomy(PNL) operation.Our one year retrospective study of patients treated with PNL, revealed that, 71% of all patients undergoing PNL operation had a NRS score 3-10 in the PACU, and they needed substantial amounts of opioids to alleviate the postoperative pain
MedDRA version: 18.1Level: LLTClassification code 10038286Term: Regional nerve blockSystem Organ Class: 100000004865
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2015-004770-16-DK

Lead Sponsor: Jens Børglum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

PErforming elective PNL in general anesthesia, Received written and oral information about the study and sign the infromed consent form of participating the study, ASA 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 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

Unabel to understand Danish in written or spoken language, Unable to Cooperato to the procedure, daily use of opioids
Known abouse of alcohol ore medication
Diffcuilities in visualizing nerve ore muscle structure necessary for performing the block
Pregnant women

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate whether a unilateral USG TQL block can reduce opioid consumption with clinical significance in PNL-patients.;Secondary Objective: not applicable;Primary end point(s): total doses of Opioid during the first 6 postoperative hours;Timepoint(s) of evaluation of this end point: 6 hours

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Total dose of opioids during the first 24 hours,NRS (0-10) pain scores at rest, time in recovery, time to ambulation, total Length of stay;Timepoint(s) of evaluation of this end point: 24 hours