Effect of the Uterotonic Carbetocin on Acute Post Cesarean-Section Pain, A Prospective Randomised Study
Trial Snapshot
- Phase
- Phase 4
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Cesarean delivery scar cutaneous hyperalgesia
Study Overview
Brief Summary
Carbetocin is an oxytocin agonist used for prevention of postpartum bleeding after cesarean delivery. First studies revealed in 2012 an analgesic effect of carbetocin, compared to its parent substance oxytocin. This study will enroll 78 women undergoing cesarean delivery. In a double-blind, prospective design patients will be either attributed to the oxytocin or the carbetocin study arm. The primary endpoint will be the area of hyperalgesia around the cesarean delivery scar. This will be performed with a von Frey hair, resulting in a unpleasant feeling in the area of hyperalgesia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age 18-45, uneventful pregnancy, on term (>37 0/7 weeks of gestation), scheduled elective CS including repeat CS
Exclusion Criteria
- •lack of informed consent, active labor, multiple pregnancy, polyhydramnios, severe fetal malformations
Arms & Interventions
Carbetocin
100 mcg of Carbetocin, Ferring, Switzerland, as iv administration after birth of the baby. For blinding purposes an intravenous infusion of 500 ml G Na (GlucoSalin 2:1; 2/3 glucose 5%+1/3 NaCl 0.9%) is administered over 6 hours.
Intervention: Carbetocin (Drug)
Outcomes
Primary Outcomes
Cesarean delivery scar cutaneous hyperalgesia
Time Frame: 4 hours after cesarean delivery
In the area of the cesarean delivery scar, the area of dynamic secondary hyperalgesia for punctate mechanical stimuli around the surgical incision will be measured around her scar according to the method described by Stubhaug et al. In brief, stimulation with a Von Frey Filament (225.1gr) is started from outside the hyperalgesic area where no pain sensation is experienced toward the incision until the patient reports a distinct change in perception. The first point where a painful, sore, or sharp feeling appears is recorded, and the distance to the incision is measured. If no change in sensation appears, stimulation is stopped at 0.5 cm from the incision. The area of secondary hyperalgesia is determined by testing along radial lines separated by 5 cm around the incision. The observations are translated onto graph paper, and the surface is calculated as cm2/cm of incision.
Secondary Outcomes
- Pressure pain detection threshold(6 weeks after cesarean)
- Baseline depression detection(before cesarean)
- Postpartum depression(6 weeks post cesarean)
- Cesarean delivery scar cutaneous hyperalgesia(6 weeks after cesarean)