Poor postoperative pain control leads to decreased satisfaction with care, prolonged recovery time and increased use of health care resources. Despite their efficacy, opioids are associated with nausea, vomiting, pruritus, drowsiness, and the risk for respiratory depression. As an alternatif, continuous wound infusion using a multi-orifice catheter with a local anesthetic has been suggested for pain therapy, however conflicting results are found in randomized controlled trials.
Conditions
Interventions
Trade Name: Ropivacaïne Fresenius Kabi 2 mg/ml, 200 ml
Pharmaceutical Form: Injection
Pharmaceutical form of the placebo: Suspension for injection
Route of administration of the placebo: Infiltration
Sponsors
CHU Tivoli
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria will be all patients undergoing cesarean delivery with - a gestation of 34 weeks or more - American Society of Anesthesiology (ASA) I or II - = age 18 years - signed 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 68 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria will be - allergies to used analgesics - ASA III or higher - pre- or eclampsia - diabetes mellitus type I or II - postpartum hemorrhage (defined as = 1 L blood loss) - BMI = 35 - preoperative opioid consumption/abuse - psychiatric disorders - patient refusal to participate - language barrier
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the trial is to evaluate the efficacy of continuous ropivacaine wound infusion through a multi-orifice catheter after cesarean delivery by comparing it with a continuous placebo wound infusion. ;Secondary Objective: The secondary objective is to evaluate the effect of continuous ropivacaine wound infusion through a multi-orifice catheter after cesarean delivery on pain intensity, on the incidence of opioids related adverse effects (post-operative nausea and vomiting, pruritus) and the time of first ambulation.;Primary end point(s): The primary outcome will be the total amount of opioid use, measured on the PCA device, in the first 48 hours after cesarean delivery.;Timepoint(s) of evaluation of this end point: Timepoint 0 hours: start of cesarean section defined as time of skin incision. Timepoint 48 hours: period of 48 hours after surgery in which opioids use by PCA will be recorded. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary outcomes will be the intensity of pain, the incidence of adverse effects (post-operative nausea and vomiting, pruritus) and time of first ambulation. Pain will be evaluated by visual analog scale (VAS) (0-10) at rest and at mobilization (defined as pain during coughing) 2 hours, 6 hours, 12 hours and 24 hours after surgery (except if the patient is asleep) and once daily until discharge thereafter. The VAS tool will consist of a 10-cm horizontal line with at one end no pain and at the other end worst pain ever. Patients will be asking to mark the point on the scale that corresponded to their pain. Post-operative nausea and vomiting and pruritus will be evaluated using a categorical scale ranging from 0 to 2 (0: none, 1: mild (requiring no treatment) and 2: severe (requiring treatment) at the same interval pain will be assessed.;Timepoint(s) of evaluation of this end point: 2 hours, 6 hours, 12 hours, 24 hours after surgery (except if the patient is asleep) and thereafter once daily until discharge of the patient, his pain and nausea and vomiting will be evaluated. Time of first ambulation after cesarian section will also be noted. | — |
Countries
Belgium
Contacts
Public ContactMichael De Brucker
CHU Tivoli
Outcome results
None listed