High dose local anesthetic compared to moderate dose for pain relief after surgery

Phase 1

• Conditions: Postoperative pain; MedDRA version: 20.0Level: PTClassification code 10000081Term: Abdominal painSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2020-002699-10-DK

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-08
• Last Update Posted: 1 February 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

•Scheduled for percutaneous nephrolithotomy
•Males/females
•Aged > 18 years
•American Society of Anesthesiology (ASA) physical status 1 - 3
•Legally competent
•Fertile women using contraception OR a negative pregnancy test (HCG)

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 8

Exclusion Criteria

•Age < 18 years
•ASA physical status =4
•Allergic to local anesthetics
•Tattoos, infection or other abnormalities at the site of injection
•No informed consent or inability to give that
•Pre-existing use of opioids
•Pregnant women
•Severe liver disease

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: We want to conduct a non-inferiority study to compare the use of high concentration to low concentration of Ropivacain. Primary outcome is the postoperative need for morphine.;Secondary Objective: Comparing high dose Ropivacain with moderate dose regarding days until discharge, lower limb weakness, nausea/vomiting and pain intensity.;Primary end point(s): •Dose of opioids/morphine at PACU<br>•Dose of opioids/morphine at the ward<br>;Timepoint(s) of evaluation of this end point: Postoperative: <br>6h<br>12h<br>24h

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Bleeding, volume (ml)<br>•Amount of anesthetics, narcotic analgesics and other adjuvants<br>•NRS in the PACU after 15m, 30m and 1h<br>•NRS in the ward at 6h, 12h and 24h after ended surgery<br>•Nausea scale in the PACU assessed at 15m, 30m and 1h.<br>•Vomiting at the PACU<br>•Antiemetics at the PACU<br>•PACU stay (minutes)<br>•Time to discharge (hours/days)<br>;Timepoint(s) of evaluation of this end point: Postoperative: <br>15min<br>30min<br>1h<br>6h<br>12h<br>24h