Efficacy of a Single-shot Wound Infiltration With Bupivacaine/Adrenalin During Cesarean Section in Reducing Postoperative Pain. A Randomized Prospective Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Intervention
- Conditions
- Cesarean Section
- Sponsor
- HaEmek Medical Center, Israel
- Enrollment
- 288
- Locations
- 1
- Primary Endpoint
- Self reported pain intensity upon receipt of a woman after cesarean section to the maternity department.
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Intervention
Infiltration of the subcutaneous layer with local anesthetic and combined with adrenaline.
Intervention: Intervention
Outcomes
Primary Outcomes
Self reported pain intensity upon receipt of a woman after cesarean section to the maternity department.
Time Frame: 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 Outcomes
- Length of the cesarean section(up to 24 hours)
- Need for opioids(up to 4 days)
- Length of stay from surgery to discharge(up to 4 days)
- Time from surgery to mobility(up to 48 hours)
- Time from surgery to breastfeeding(up to 4 days)
- surgical site infection(up to 42 days)
- Surgical site hematoma(4 days)
- questionnaire(up to 4 days)