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

HaEmek Medical Center, Israel

Status: Completed

Conditions: Cesarean Section

Treatments: Drug: Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03395912

0151-17-EMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 288 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

288 participants in 2 patient groups

Intervention

Experimental group

Description:

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

Treatment:

Drug: Intervention

control

No Intervention group

Description:

Abdominal layers will be closed without Infiltration .