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Lidocaine and Magnesium and Ketamine in Gynecological Surgery

NCT04622904 · annie-sophia · Aretaieion University Hospital

Closed to entry
Status
Not accepting participants
Not applicable
Phase
90
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

The aim of this study will be to investigate the effect of a combination of intravenous infusions of lidocaine and magnesium versus a combination of intravenous infusions of lidocaine and ketamine versus an intravenous infusion of lidocaine alone on recovery profile, quality of recovery and postoperative pain after elective gynecological surgery

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • change from baseline in Quality of Recovery (QoR)-15 score after surgery

    Measured over 24 hours postoperatively

  • pain score on arrival to Post-Anesthesia Care Unit (PACU)

    Measured over immediately postoperatively

  • pain score at discharge from Post-Anesthesia Care Unit (PACU)

    Measured over at discharge from PACU, approximately 1 h postoperatively

  • pain score 3 hours postoperatively

    Measured over 3 hours postoperatively

  • pain score 6 hours postoperatively

    Measured over 6 hours postoperatively

  • pain score 24 hours postoperatively

    Measured over 24 hours postoperatively

  • pain score 48 hours postoperatively

    Measured over 48 hours postoperatively

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

25 Years to 75 Years
Ages
FEMALE
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * adult female patients * American Society of Anesthesiologists (ASA) classification I-II * elective open gynecological surgery Exclusion Criteria: * body mass index (BMI) \>35 kg/m2 * contraindications to local anesthetic administration or non-steroidal agents administration * systematic use of analgesic agents preoperatively * chronic pain syndromes preoperatively * neurological or psychiatric disease on treatment * pregnancy * severe hepatic or renal disease * history of cardiovascular diseases/ arrhythmias/ conduction abnormalities * drug or alcohol abuse * language or communication barriers * lack of informed consent

Where

1 study site

FacilityCityRegionCountry
Aretaieion University HospitalAthensGreece

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT04622904 on ClinicalTrials.gov →

Last updated in the registry 2022-10-27. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits