Postoperative pain after cesarean section.
Conditions
Interventions
Product Name: Marcain adrenaline 2.5 mg/ml + 5 microgram/ml
Pharmaceutical Form: Injection*
Pharmaceutical form of the placebo: Injection*
Route of administration of the placebo: Subcutaneous use
Sponsors
Karolinska University Hospital, Huddinge
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients undergoing elective cesarean section at the Karolinska University Hospital, Huddinge. Age 18-50 years. Written consent to participate in the study. 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Participation in another clinical trial within the last month before inclusion or during the study period. Other cause of pain with frequent use of potent analgetics. Other conditions that makes participation in the study difficult, like drug abuse, severe psychiatric disease or marked difficulties to communicate according to judgement of the investigator. Known intolerance or allergic reactions to opiates. Known intolerance or allergic reactions to NSAID. Known intolerance or allergic reactions to bupivacaine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to evaluate whether local peroperative administration of bupivacain with adrenaline (2,5 mg/ml and 5 microgram/ml) can decrease postoperative pain after cesarean section, decrease opiate consumption, decrease the time to mobilisation, the incidence of wound infections and long term scar pain. Primary variables: Does bupivacaine influence the maximal postoperative pain during the first 24 hours? Does bupivacaine decrease the opiate consumption after 6, 12 and 24 hours (separately and accumulated)? Will administration of bupivacaine influence the time for mobilisation of the patient measured as the time period until the patients goes to the toilet for the first time, until the patient has her first defecation and until the medical treatment of the patient is considered finished? ;Secondary Objective: Secondary variables: Will bupivacaine change the incidence of wound infections during the stay in the hospital? Will bupivacaine influence whether analgesia is still needed or not 10 days after the operation. Will bupivacaine influence the incidence of scar pain at 3, 6 and 12 months after the operation. ;Primary end point(s): Reduction in maximal pain during the first 24 hours? Reduction in use of opiates during the first 6, 12 and 24 hours? Shortened time for mobilisation, measured as time from the operation to first visit to the toilet, first defecation and to the end of the medical treatment period? | — |
Countries
Sweden
Outcome results
None listed