Clinical trial NCT06692621: Effects of Carbetocin and Oxytocin Used in Cesarean Sections on Postoperative Pain
Official title: Effects of Carbetocin and Oxytocin Used in Cesarean Sections on Postoperative Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PREG1
Keywords: carbetocin
oxytocin
cesarean analgesia
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-11-18
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women between the ages of 18-45

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative 24-hour analgesic consumption (Total tramadol mg / 24 hours )
timeFrame: 04/10/2024-04/01/2025
Secondary outcomes:
measure: amount of intraoperative bleeding (Preoperative / postoperative hemoglobin g/dl )
timeFrame: 04/10/2024-04/01/2025
measure: Postoperative 24-hour Heart rate variables (/minute)
timeFrame: 04/10/2024-04/01/2025
measure: Postoperative 24-hour arterial blood pressure variables (mmHg)
timeFrame: 04/10/2024-04/01/2025
measure: Postoperative 24-hour oxygen saturation variables (%)
timeFrame: 04/10/2024-04/01/2025
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
Study officials:
affiliation: esrauyarturkyilmaz@yahoo.com
name: Havva Esra Türkyılmaz Uyar
role: STUDY_DIRECTOR
References:
citation: De Bonis M, Torricelli M, Leoni L, Berti P, Ciani V, Puzzutiello R, Severi FM, Petraglia F. Carbetocin versus oxytocin after caesarean section: similar efficacy but reduced pain perception in women with high risk of postpartum haemorrhage. J Matern Fetal Neonatal Med. 2012 Jun;25(6):732-5. doi: 10.3109/14767058.2011.587920. Epub 2011 Jul 15.
citation: Gawecka E, Rosseland LA. A secondary analysis of a randomized placebo-controlled trial comparing the analgesic effects of oxytocin with carbetocin: postcesarean delivery morphine equivalents. Anesth Analg. 2014 Oct;119(4):1004. doi: 10.1213/ANE.0000000000000372. No abstract available.