Wound Infiltration With Bupivacaine/Adrenalin During Cesarean Section and Postoperative Pain.

Not Applicable

Completed

• Conditions: Cesarean Section
• Interventions: Drug: Intervention

• Registration Number: NCT03395912
• Lead Sponsor: HaEmek Medical Center, Israel

Brief Summary

Thus study evaluates the advantage of infiltration of the surgical wound by local anesthetics in cesarean section on post operative pain relief. In the study group before closing the skin, both sides of the incision (top and bottom) will be infiltrated by 30 ml of 0.25% BUPIVACAINE and ADRENALIN at 1: 200,000 concentration and then closing the skin. In the control group, the skin will be closed without infiltration. Our hypothesis is that subcutaneous infiltration of the surgical wound by BUPIVACAINE + ADRENALIN at the end of cesarean section will reduce the intensity of post operative pain.

Detailed Description

Cesarean section is one of the most common procedures in the world. There is an advantage in preventing pain after cesarean section, as opposed to treating pain that has already started. The infiltration of surgical wounds by local anesthetics is accepted as an effective method for preventing pain after various operations. In this study women who are admitted for a cesarean section will be randomly allocated into 2 groups. In the study group after the closure of the fascia above the rectus muscles, and before closing the skin, both sides of the incision (top and bottom) will be infiltrated by 30 ml of 0.25% BUPIVACAINE and ADRENALIN at 1: 200,000 concentration and then closing the skin. In the control group, the skin will be closed without infiltration.

Study Timeline

• Study First Submitted: 2017-12-21
• Study First Submitted QC: 2018-01-04
• Study First Posted: 2018-01-10
• Study Start: 2018-01-25
• Primary Completion: 2020-05-30
• Study Completion: 2021-06-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-18
• Last Update Posted: 2022-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 288

Inclusion Criteria

• cesarean section with regional anesthesia
• singleton
• pfannenstiel incision

Exclusion Criteria

• cesarean section with general anesthesia
• maternal liver or kidney disease
• allergy to Bupivacaine
• allergy to Adrenalin
• intrauterine fetal death
• major fetal malformations

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Intervention	Infiltration of the subcutaneous layer with local anesthetic and combined with adrenaline.

Primary Outcome Measures

Name	Time	Method
Self reported pain intensity upon receipt of a woman after cesarean section to the maternity department.	up to 24 hours	Visual analogue scale pain severity with scale from 0 to 10, with score 10 representing the maximum level of pain.

Secondary Outcome Measures

Name	Time	Method
Length of the cesarean section	up to 24 hours	Time from first incision to the end of incision closure
Need for opioids	up to 4 days	Type and dosage of opioids needed
Length of stay from surgery to discharge	up to 4 days	Length of stay from surgery to discharge
Time from surgery to mobility	up to 48 hours	Time from the end of surgery to mobility
Time from surgery to breastfeeding	up to 4 days	Time from the end of surgery to breastfeeding
surgical site infection	up to 42 days	Post operative surgical site infection
Surgical site hematoma	4 days	Post operative surgical site hematoma
questionnaire	up to 4 days	Post operative women's satisfaction with scale from 0 to 10, with score 10 representing the maximum level of satisfaction.

Trial Locations

Locations (1)

HaEmek medical center; 🇮🇱 Afula, Israel