ocal anaesthesia as add-on therapy to general anaesthesia in gynecological laparoscopy.

Conditions: Gynecological patients referred for elective day-care laparoscopic surgery.
MedDRA version: 14.1Level: LLTClassification code 10021946Term: Infiltration anesthesiaSystem Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 14.1Level: PTClassification code 10023693Term: LaparoscopySystem Organ Class: 10022891 - Investigations
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

Registration Number: EUCTR2012-002356-16-NO

Lead Sponsor: Stavanger University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

- Women =18 years of age
- Planned day-case laparoscopic surgery
- Signed Written Informed Consent

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 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

- Chronic pain
- Regular use of any analgetics
- Inability to understand Norwegian language
- Drug or alcohol abuse
- Inability to understand or sign the Written Informed Consent form of the study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To test if pre-emptive injection of long-lasting, local anaesthetics given in addition to general anesthesia reduces post-operative pain.;Secondary Objective: Not applicable.;Primary end point(s): Movement-evoked pain (MEP) as reported by a Numerical Rating Scale (NRS).;Timepoint(s) of evaluation of this end point: 5 hours after surgery.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Pain at rest as reported by a Numerical Rating Scale (NRS).;Timepoint(s) of evaluation of this end point: 2 and 5 hours after surgery.