A study that examines the postoperative pain and Morphine use of patients who received systemic Lidocain administration during oncological gynaecological surgery.

Phase 1

• Conditions: postoperative pain; MedDRA version: 16.0Level: LLTClassification code 10036236Term: Postoperative pain reliefSystem Organ Class: 100000004865; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2013-003255-38-BE
• Lead Sponsor: niversity hospitals Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-20
• Last Update Posted: 5 June 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

•ASA 1,2 en 3
•Elective gynaecological oncological surgery for ovarium carcinoma
•age = 18 year of age
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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

Allergy to Lidocaine
chronic use of opioids
Liver and renal insuffiency
epilepsy
cardiac dysrhythmia
mental retardation

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Does the peri-operative systemic administration of Lidocain reduce the postoperative consumption of Opioids;Secondary Objective: Does the peri-and postoperative administration of Lidocaine reduce:<br>- The inflammatory respons<br>- The incidence of PONV<br>- the developement of persisting pain <br>- the length of hospitalisation<br>- the tumor recidive and metastases.;Primary end point(s): Is the systemic peri-and postoperative administration of Lidocaine effective to treat postoperative pain after oncological gynaecological surgery?;Timepoint(s) of evaluation of this end point: every 15 minutes for the first 2 hours postoperatively; <br>the following 22 hours: every hour<br><br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Does the peri-and postoperative administration of Lidocaine reduce:<br>- The inflammatory respons<br>- The incidence of PONV<br>- The developement of persisting pain <br>- The length of hospitalisation<br>- The tumor recidive and metastases.<br>- The incidence of PONV<br>;Timepoint(s) of evaluation of this end point: every 15 minutes for the first 2 hours postoperative<br>The following 22 hours: every hour<br>once daily on postoperative day 2 and 3<br> 3 and 6 month postoperative (telephone call)