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

High dose Ropivacaine versus moderate dose for quadratus lumborum block as postoperative analgesia after percutaneous nephrolithotomy – a blinded randomized non-inferiority study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002699-10-DK

Enrollment

Registered

2020-10-08

Start date

2021-01-06

Completion date

Unknown

Last updated

2022-02-01

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

Conditions

Postoperative pain MedDRA version: 20.0 Level: PT Classification code 10000081 Term: Abdominal pain System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Trade Name: Ropivacain Pharmaceutical Form: Injection INN or Proposed INN: ROPIVACAINE CAS Number: 84057-95-4 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 • Dose of opioids/morphine at the ward ;Timepoint(s) of evaluation of this end point: Postoperative: 6h 12h 24h	—

Measure

Time frame

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 • Dose of opioids/morphine at the ward ;Timepoint(s) of evaluation of this end point: Postoperative: 6h 12h 24h

—

Secondary

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

Measure

Time frame

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

—

Countries

Denmark

Contacts

Public ContactDepartment of anesthesiology

Aalborg University hospital

p.soendergaard@rn.dk+4597662929

Outcome results

None listed

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