NCT03395912

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

Efficacy of a Single-shot Wound Infiltration With Bupivacaine/Adrenalin During Cesarean Section in Reducing Postoperative Pain. A Randomized Prospective Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 288 (actual)
• Sponsor: HaEmek Medical Center, Israel · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cesarean Section

Interventions

Type	Name	Description
DRUG	Intervention	After closing the fascia above the rectus muscles, and before closing the skin, the subcutaneous layer will be infiltrated on both sides of the incision (top and bottom) by 30 ml of 0.25% BUPIVACAINE and ADRENALIN at 1: 200,000 concentration and then closing the skin.

Timeline

• Start date: 2018-01-25
• Primary completion: 2020-05-30
• Completion: 2021-06-30
• First posted: 2018-01-10
• Last updated: 2022-10-19

Locations

1 site across 1 country: Israel