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

October 18, 2022 updated by: HaEmek Medical Center, Israel

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

288

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Afula, Israel
        • Haemek Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Infiltration of the subcutaneous layer with local anesthetic and combined with adrenaline.
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.
Other Names:
  • local anesthetic infiltration
No Intervention: control
Abdominal layers will be closed without Infiltration .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of the cesarean section
Time Frame: up to 24 hours
Time from first incision to the end of incision closure
up to 24 hours
Time from surgery to mobility
Time Frame: up to 48 hours
Time from the end of surgery to mobility
up to 48 hours
Time from surgery to breastfeeding
Time Frame: up to 4 days
Time from the end of surgery to breastfeeding
up to 4 days
Need for opioids
Time Frame: up to 4 days
Type and dosage of opioids needed
up to 4 days
Surgical site hematoma
Time Frame: 4 days
Post operative surgical site hematoma
4 days
surgical site infection
Time Frame: up to 42 days
Post operative surgical site infection
up to 42 days
questionnaire
Time Frame: up to 4 days
Post operative women's satisfaction with scale from 0 to 10, with score 10 representing the maximum level of satisfaction.
up to 4 days
Length of stay from surgery to discharge
Time Frame: up to 4 days
Length of stay from surgery to discharge
up to 4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HaEmek Medical Center, Israel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2018

Primary Completion (Actual)

May 30, 2020

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

December 21, 2017

First Submitted That Met QC Criteria

January 4, 2018

First Posted (Actual)

January 10, 2018

Study Record Updates

Last Update Posted (Actual)

October 19, 2022

Last Update Submitted That Met QC Criteria

October 18, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0151-17-EMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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