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Perioperative Intravenous Metamizole in Laparoscopic Cholecystectomy: A rondomized, double blind, clinical trial.

Status
Not yet recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2026-526531-18-00
Enrollment
76
Registered
2026-07-31
Start date
Unknown
Completion date
Unknown
Last updated
2026-07-31

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

Conditions

Post operative pain relief in Patients undergoing laparoscopic cystectomy in day-surgery clinic

Brief summary

The primary endpoint is the opioid consumption in IV morphine milligram equivalents (MME) administered peroperatively and during the first 3 postoperative hours.

Detailed description

Mean NRS (evaluated every 15 minutes until 60’ postoperative (+0’ +15’, +30’, +45’, +60’)), Number of given doses of rescue analgesia on PACU, Mean NRS hourly after PACU stay until discharge, Time to first rescue analgesia in PACU, Time to be ready for discharge from hospital Day Care Unit, Opioid consumption until discharge (IV morphine equivalents), Analgesic consumption (0-48h postoperative), Aldrete score (evaluated every 15, during PACU stay), PADSS (every hour from admission to Day Care Unit until discharge from hospital), QoR-15 POD1 and POD2

Interventions

DRUGNOVALGINE I.M./I.V. 1000 mg/2 ml solution injectable
DRUG9 %
DRUGoplossing voor injectie

Sponsors

UZ Leuven
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary endpoint is the opioid consumption in IV morphine milligram equivalents (MME) administered peroperatively and during the first 3 postoperative hours.

Secondary

MeasureTime frame
Mean NRS (evaluated every 15 minutes until 60’ postoperative (+0’ +15’, +30’, +45’, +60’)), Number of given doses of rescue analgesia on PACU, Mean NRS hourly after PACU stay until discharge, Time to first rescue analgesia in PACU, Time to be ready for discharge from hospital Day Care Unit, Opioid consumption until discharge (IV morphine equivalents), Analgesic consumption (0-48h postoperative), Aldrete score (evaluated every 15, during PACU stay), PADSS (every hour from admission to Day Care Unit until discharge from hospital), QoR-15 POD1 and POD2

Outcome results

None listed

Source: EU CTIS · Data processed: Aug 1, 2026