analgesia with continuous IV-infusion of lidocain during the perioperative period in patients undergoin laparoscopic sterilization.
Phase 1
- Conditions
- postoperative painTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2011-001315-31-BE
- Lead Sponsor
- niversity Hospitals Leuven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 80
Inclusion Criteria
ASA I or II
surgical sterilization
> 18 years
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 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
allergy to lidocaine
chronic use op opioids
liver and renal insuffiency
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Is the perioperative IV administration of lidocaine an effective treatment to reduce postoperative pain after surgical sterilization.;Secondary Objective: Does the IV administration of lidocaine during the perioperative period reduce:<br>- the incidence of postoperative pain<br>- the consumption of co-analgesics<br>- the incidence of PONV<br>- the length of hospital stay;Primary end point(s): Is the continuous systemic perioperative administration of lidocain effective to treat visceral pain after lararoscopic sterilisation in daycare ?;Timepoint(s) of evaluation of this end point: every 15 min. for the first 2 hours postoperatively
- Secondary Outcome Measures
Name Time Method Secondary end point(s): incidence of PONV<br>less need of analgesics to reduce postoperatvie pain;Timepoint(s) of evaluation of this end point: every 15 min. for the first 2 hours postoperatively