Clinical trial NCT03395912: Wound Infiltration With Bupivacaine/Adrenalin During Cesarean Section and Postoperative Pain.
Official title: Efficacy of a Single-shot Wound Infiltration With Bupivacaine/Adrenalin During Cesarean Section in Reducing Postoperative Pain. A Randomized Prospective Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section
Keywords: local anesthetics infiltration
cesarean section pain relief
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2018-01-10
Enrollment: 288
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Self reported pain intensity upon receipt of a woman after cesarean section to the maternity department.
timeFrame: up to 24 hours
Secondary outcomes:
measure: Length of the cesarean section
timeFrame: up to 24 hours
measure: Time from surgery to mobility
timeFrame: up to 48 hours
measure: Time from surgery to breastfeeding
timeFrame: up to 4 days
measure: Need for opioids
timeFrame: up to 4 days
measure: Surgical site hematoma
timeFrame: 4 days
measure: surgical site infection
timeFrame: up to 42 days
measure: questionnaire
timeFrame: up to 4 days
measure: Length of stay from surgery to discharge
timeFrame: up to 4 days
Other outcomes:
Locations:
city: Afula
country: Israel
facility: HaEmek medical center
Study officials:
affiliation: HaEmek Medical Center, Afula, Israel
name: Gali Garmi, MD
role: PRINCIPAL_INVESTIGATOR
References:
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