Effect of the Uterotonic Carbetocin on Acute Post Cesarean-Section Pain

NCT02642263 | Unknown Phase 4

• 1 other identifier: Uterotonic Carbetocin
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Delivery

Outcome Measures

Primary Outcomes (1)

• Cesarean delivery scar cutaneous hyperalgesia

  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.

  4 hours after cesarean delivery

Secondary Outcomes (10)

• Pressure pain detection threshold

  before cesarean

• Pressure pain detection threshold

  4 hours after cesarean

• Pressure pain detection threshold

  24 hours after cesarean

• Pressure pain detection threshold

  48 hours after cesarean

• Pressure pain detection threshold

  6 weeks after cesarean

Study Arms (2)

Oxytocin

NO INTERVENTION

Oxytocin 20 IE in 500 ml G Na intravenous infusion over 6 hours (GlucoSalin 2:1; 2/3 glucose 5%+1/3 NaCl 0.9%), Sintetica-Bioren, Switzerland, after birth of the baby. For blinding purposes a 3ml NaCl 0.9% syringe is administered intravenously after birth of the baby as well.

Carbetocin

EXPERIMENTAL

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.

Drug: Carbetocin

Interventions

Carbetocin DRUG

Postpartum uterotonic drug

Also known as: Pabal, Ferring, Baar, Switzerland

Carbetocin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-45, uneventful pregnancy, on term (\>37 0/7 weeks of gestation), scheduled elective CS including repeat CS

You may not qualify if:

• lack of informed consent, active labor, multiple pregnancy, polyhydramnios, severe fetal malformations

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Dep. of Anesthesiology and Pain Medicine, Bern University Hospital

Bern, 3010, Switzerland

Location

MeSH Terms

Interventions

carbetocin

Study Officials

• Daniel Surbek, Prof

  Bern University Hospital

  STUDY DIRECTOR

Central Study Contacts

Pascal H Vuilleumier, MD

CONTACT

+41 31 632 21 11; pascal.vuilleumier@insel.ch

Juerg Schliessbach, MD

CONTACT

+41 31 632 21 11; juerg.schliessbach@insel.ch

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2015
• First Posted: December 30, 2015
• Study Start: February 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: January 1, 2022
• Last Updated: May 4, 2018

Record last verified: 2018-05

Locations

CH (1)