Exteriorized Versus In Situ Uterine Repair at Cesarean Delivery

Pain Clinical Trial

Official title:

Complications of Exteriorized Versus In Situ Uterine Repair at Cesarean Delivery Under Spinal Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00452972
• Other study ID #: 07-04
• Secondary ID: 04-0057-A
• Status: Completed
• Phase: N/A
• First received: March 19, 2007
• Last updated: March 26, 2007
• Start date: April 2004
• Est. completion date: December 2004

Study information

• Verified date: March 2007
• Source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

This study was undertaken to compare the two techniques (exteriorized vs in situ) of uterine repair with respect to patient comfort, hemodynamic changes, surgical time and blood loss, in patients undergoing elective CD under a strictly standardized spinal anesthetic. We hypothesized that in situ uterine repair would be more comfortable for the patients.

Description:

Uterine repair during Cesarean delivery can be done either by exteriorizing the uterus and replacing it into the abdominal cavity after the completion of a double layer closure, or by suturing it in situ. Exteriorization of the uterus has been shown to decrease blood loss during Cesarean delivery when compared to in situ repair. However, at the same time, it is thought to be uncomfortable for the patient with respect to intraoperative nausea, vomiting and pain. Intraoperative nausea and vomiting in patients who receive regional anaesthesia for Cesarean section is a complex multifactorial problem arising from anesthetic and non-anesthetic causes. Additionally, it can influence hemodynamic stability.

The study was a prospective, randomized and single blinded study. It compared the effects of exteriorization of the uterus and in-situ repair during Cesarean delivery with respect to patient’s comfort, hemodynamic changes, uterine contractility and blood loss in patients under spinal anesthesia. All low risk patients undergoing elective C-delivery under spinal anesthesia were considered for this study.

Spinal anesthesia was performed in the sitting position with 10-12 mg of 0.75% hyperbaric bupivacaine, mixed with 100 mcg of preservative free morphine and 10 mcg of fentanyl. Any drop in blood pressure was treated with 100 mg of phenylephrine titrated to maintain systolic blood pressure within 10% of the baseline values throughout the procedure. Oxytocin was used judiciously, in aliquots of 0.5 IU. Obstetricians were asked to allow assisted spontaneous delivery of placenta rather than manual extraction. During surgery, patient’s complaints of nausea, vomiting, pain or any discomfort were recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy pregnant women scheduled for elective cesarean delivery

Exclusion Criteria:

• ASA III or IV patients

• Patient with conditions that predispose to uterine atony and post partum hemorrhage

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypotension
• Nausea
• Pain
• Tachycardia
• Vomiting

Intervention

Drug:
• Spinal Anesthesia

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative nausea or vomiting after deliver of the infant
Secondary	Intraoperative pain
Secondary	Calculated blood loss
Secondary	Uterine contractility
Secondary	Hypotension
Secondary	Heart rate changes
Secondary	Duration of uterine repair