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

NCT ID: NCT02642263

Last Updated: 2018-05-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2022-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Oxytocin

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Carbetocin

Intervention Type: DRUG

Postpartum uterotonic drug

Interventions

Carbetocin

Postpartum uterotonic drug

Intervention Type: DRUG

Other Intervention Names

Pabal, Ferring, Baar, Switzerland

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Surbek, Prof

Role: STUDY_DIRECTOR

Bern University Hospital

Locations

Dep. of Anesthesiology and Pain Medicine, Bern University Hospital

Bern, , Switzerland

Countries

Switzerland

Central Contacts

Pascal H Vuilleumier, MD

Role: CONTACT

pascal.vuilleumier@insel.ch

+41 31 632 21 11 ext. 8239

Juerg Schliessbach, MD

Role: CONTACT

juerg.schliessbach@insel.ch

+41 31 632 21 11 ext. 7818

Facility Contacts

Pascal H Vuilleumier, MD

Role: primary

pascal.vuilleumier@insel.ch

+41 (0)31 632 21 11

Juerg Schliessbach, MD

Role: backup

juerg.schliessbach@insel.ch

+41 (0)31 632 21 11 ext. 7818

Other Identifiers

Uterotonic Carbetocin

Identifier Type: -

Identifier Source: org_study_id