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Effects of Carbetocin and Oxytocin Used in Cesarean Sections on Postoperative Pain

Effects of Carbetocin and Oxytocin Used in Cesarean Sections on Postoperative Pain

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06692621
Enrollment
120
Registered
2024-11-18
Start date
2024-10-04
Completion date
2025-01-10
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PREG1

Keywords

carbetocin, oxytocin, cesarean analgesia

Brief summary

The aim of this observational study is to compare postoperative analgesic consumption in patients who received peroperative carbetocin or oxytocin. The main question it aims to answer is: . Does peroperative carbetocin use reduce postoperative analgesic consumption compared to oxytocin? Patients who receive routine uterotonic agents in caesarean section surgeries will be divided into two groups and their postoperative 24-hour analgesic consumption will be compared.

Detailed description

Postpartum hemorrhage (PPH) is one of the most important causes of perioperative maternal deaths. Oxytocin and carbetocin are the most important uterotonic agents used for PPH. Oxytocin has a half-life of 4-10 minutes (min) and can provide continuous uterotonic properties through infusion. Carbetocin, which has been used increasingly in recent years, is a synthetic analogue of oxytocin and has a strong uterotonic effect on oxytocin receptors. Oxytocin, which is used in PPH prophylaxis and management in cesarean delivery, has some maternal side effects depending on the rate of administration. These are cardiovascular effects, nausea, vomiting, headache and allergic reactions. Since it is structurally similar to vasopressin, water retention in the body and hyponatremia, convulsions and coma can be seen, although rarely. The most common cardiac effects after oxytocin administration are dose-dependent hypotension and tachycardia. Smooth muscle relaxation caused by stimulation of calcium-dependent nitrite oxide is held responsible for hypotension.\[3\] Carbetocin, a long-acting oxytocin analog, has similar side effects and further research is needed on its effectiveness. There are potential studies supporting that the oxytocinergic system affects pain perception. Oxytocin released into the central nervous system plays an important role in the transmission and modulation of pain signals. Glutamatergic activation of oxytocin in the dorsal root ganglia results in GABAergic inhibition of Aδ and C fibers that play a role in nociception. Carbetocin is also thought to have similar effects in analgesia. Although there are studies showing that carbetocin reduces postoperative analgesic use compared to oxytocin , there is no clear consensus in the literature on this subject. The studies conducted by De Bonis et al. and Gawecka et al. were guiding in designing this study. While De Bonis et al. found that carbetocin reduces analgesic consumption, Gawecka et al. could not show a significant difference between the two agents. In this study, the investigators aim to contribute to the literature by comparing the analgesic activities of oxytocin and carbetocin to observe the differences in hemodynamic and other side effects of these two agents.

Interventions

DRUGOxytocin

Medicines were administered in appropriate doses

DRUGCarbetocin

Medicines were administered in appropriate doses

Sponsors

Ankara City Hospital Bilkent
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Pregnant women in the American Society of Anesthesiologists (ASA) II class, * who have had a previous uncomplicated cesarean delivery, * who are 18-45 years old and are planned to undergo elective cesarean section with spinal anesthesia technique

Exclusion criteria

* Patients who cannot use the patient controlled analgesia (PCA) device postoperatively, * have limited intellectual function * have contraindications for spinal anesthesia

Design outcomes

Primary

MeasureTime frameDescription
Postoperative 24-hour analgesic consumption (Total tramadol mg / 24 hours )04/10/2024-04/01/2025analgesic consumption

Secondary

MeasureTime frameDescription
amount of intraoperative bleeding (Preoperative / postoperative hemoglobin g/dl )04/10/2024-04/01/2025intraoperative bleeding
Postoperative 24-hour Heart rate variables (/minute)04/10/2024-04/01/2025Postoperative 24-hour hemodynamic variables
Postoperative 24-hour arterial blood pressure variables (mmHg)04/10/2024-04/01/2025Postoperative 24-hour hemodynamic variables
Postoperative 24-hour oxygen saturation variables (%)04/10/2024-04/01/2025Postoperative 24-hour hemodynamic variables

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026