Gynecological patients referred for elective day-care laparoscopic surgery. MedDRA version: 14.1 Level: LLT Classification code 10021946 Term: Infiltration anesthesia System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: PT Classification code 10023693 Term: Laparoscopy System Organ Class: 10022891 - Investigations
Conditions
Interventions
Trade Name: Marcain
Product Name: Marcain
Pharmaceutical Form: Injection
INN or Proposed INN: BUPIVACAINE HYDROCHLORIDE
CAS Number: 18010-40-7
Other descriptive name: Marcaine
Concentration unit: mg/m
Sponsors
Stavanger University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Norway
Contacts
Public ContactCaroline Ravndal, Investigator
Stavanger University Hospital
Outcome results
None listed