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

NCT06692621 | Completed

• 1 other identifier: E2-234595
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

PREG1

Keywords

carbetocin; oxytocin; cesarean analgesia

Outcome Measures

Primary Outcomes (1)

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

  analgesic consumption

  04/10/2024-04/01/2025

Secondary Outcomes (4)

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

  04/10/2024-04/01/2025

• Postoperative 24-hour Heart rate variables (/minute)

  04/10/2024-04/01/2025

• Postoperative 24-hour arterial blood pressure variables (mmHg)

  04/10/2024-04/01/2025

• Postoperative 24-hour oxygen saturation variables (%)

  04/10/2024-04/01/2025

Study Arms (2)

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.

Drug: Oxytocin

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.

Drug: Carbetocin

Interventions

Oxytocin DRUG

Medicines were administered in appropriate doses

Also known as: Deva İlaç Sanayi, Turkey

O:oxytocin

Carbetocin DRUG

Medicines were administered in appropriate doses

Also known as: Ferring GmbH, Germany

C:carbetocin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Only pregnant women were included in our study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pregnant women between the ages of 18-45

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Ankara, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 21761999 BACKGROUND

• 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.

  PMID: 25232698 BACKGROUND

Related Links

• main source
• main source

MeSH Terms

Interventions

Oxytocin; carbetocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Havva Esra Türkyılmaz Uyar

  esrauyarturkyilmaz@yahoo.com

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: November 18, 2024
• Study Start: October 4, 2024
• Primary Completion: January 7, 2025
• Study Completion: January 10, 2025
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)