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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03395912
Enrollment
288
Registered
2018-01-10
Start date
2018-01-25
Completion date
2021-06-30
Last updated
2022-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section

Keywords

local anesthetics infiltration, cesarean section pain relief

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.

Interventions

DRUGIntervention

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.

Sponsors

HaEmek Medical Center, Israel
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Self reported pain intensity upon receipt of a woman after cesarean section to the maternity department.up to 24 hoursVisual analogue scale pain severity with scale from 0 to 10, with score 10 representing the maximum level of pain.

Secondary

MeasureTime frameDescription
Length of the cesarean sectionup to 24 hoursTime from first incision to the end of incision closure
Time from surgery to mobilityup to 48 hoursTime from the end of surgery to mobility
Time from surgery to breastfeedingup to 4 daysTime from the end of surgery to breastfeeding
Need for opioidsup to 4 daysType and dosage of opioids needed
Surgical site hematoma4 daysPost operative surgical site hematoma
surgical site infectionup to 42 daysPost operative surgical site infection
questionnaireup to 4 daysPost operative women's satisfaction with scale from 0 to 10, with score 10 representing the maximum level of satisfaction.
Length of stay from surgery to dischargeup to 4 daysLength of stay from surgery to discharge

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026