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Completed

NCT Number: NCT06692621

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

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.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxytocin

Drug

Medicines were administered in appropriate doses

Other names: Deva İlaç Sanayi, Turkey

Carbetocin

Drug

Medicines were administered in appropriate doses

Other names: Ferring GmbH, Germany

Primary outcomes

  1. Postoperative 24-hour analgesic consumption (Total tramadol mg / 24 hours )

    Time frame: 04/10/2024-04/01/2025

    analgesic consumption

Secondary outcomes

  1. amount of intraoperative bleeding (Preoperative / postoperative hemoglobin g/dl )

    Time frame: 04/10/2024-04/01/2025

    intraoperative bleeding

  2. Postoperative 24-hour Heart rate variables (/minute)

    Time frame: 04/10/2024-04/01/2025

    Postoperative 24-hour hemodynamic variables

  3. Postoperative 24-hour arterial blood pressure variables (mmHg)

    Time frame: 04/10/2024-04/01/2025

    Postoperative 24-hour hemodynamic variables

  4. Postoperative 24-hour oxygen saturation variables (%)

    Time frame: 04/10/2024-04/01/2025

    Postoperative 24-hour hemodynamic variables

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 18, 2024
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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