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.
Study Overview
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ankara, Turkey
- Ankara Bilkent City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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O:oxytocin
In the oxytocin group, oxytocin ('Synpitan forte 5 IU/ml im/iv ampoule, Deva İlaç Sanayi, Turkey)' was administered 20 IU intravenously (5 IU intravenous bolus followed by 15 IU/hour infusion) in accordance with the recommendations of the Ministry of Health of the Republic of Turkey.
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Medicines were administered in appropriate doses
Other Names:
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C:carbetocin
In the carbetocin group, carbetocin 'Pabal 100 microgram/ml iv solution for injection ampoule, Ferring GmbH, Germany) was diluted with 20 ml of 0.9% NaCl solution and administered over 30-60 seconds.
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Medicines were administered in appropriate doses
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Postoperative 24-hour analgesic consumption (Total tramadol mg / 24 hours )
Time Frame: 04/10/2024-04/01/2025
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analgesic consumption
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04/10/2024-04/01/2025
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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amount of intraoperative bleeding (Preoperative / postoperative hemoglobin g/dl )
Time Frame: 04/10/2024-04/01/2025
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intraoperative bleeding
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04/10/2024-04/01/2025
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Postoperative 24-hour Heart rate variables (/minute)
Time Frame: 04/10/2024-04/01/2025
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Postoperative 24-hour hemodynamic variables
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04/10/2024-04/01/2025
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Postoperative 24-hour arterial blood pressure variables (mmHg)
Time Frame: 04/10/2024-04/01/2025
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Postoperative 24-hour hemodynamic variables
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04/10/2024-04/01/2025
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Postoperative 24-hour oxygen saturation variables (%)
Time Frame: 04/10/2024-04/01/2025
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Postoperative 24-hour hemodynamic variables
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04/10/2024-04/01/2025
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Havva Esra Türkyılmaz Uyar, esrauyarturkyilmaz@yahoo.com
Publications and helpful links
General Publications
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E2-234595
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Study Data/Documents
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Individual Participant Data Set
Information identifier: YöktezInformation comments: You can reach us at harunzengin71@gmail.com
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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