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

Primary Purpose

Cesarean Section

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Intervention
Sponsored by
HaEmek Medical Center, Israel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cesarean Section focused on measuring local anesthetics infiltration, cesarean section pain relief

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • HaEmek medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

control

Arm Description

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

Abdominal layers will be closed without Infiltration .

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Length of the cesarean section
Time from first incision to the end of incision closure
Time from surgery to mobility
Time from the end of surgery to mobility
Time from surgery to breastfeeding
Time from the end of surgery to breastfeeding
Need for opioids
Type and dosage of opioids needed
Surgical site hematoma
Post operative surgical site hematoma
surgical site infection
Post operative surgical site infection
questionnaire
Post 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 discharge
Length of stay from surgery to discharge

Full Information

First Posted
December 21, 2017
Last Updated
October 18, 2022
Sponsor
HaEmek Medical Center, Israel
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1. Study Identification

Unique Protocol Identification Number
NCT03395912
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 25, 2018 (Actual)
Primary Completion Date
May 30, 2020 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HaEmek Medical Center, Israel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section
Keywords
local anesthetics infiltration, cesarean section pain relief

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
288 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Infiltration of the subcutaneous layer with local anesthetic and combined with adrenaline.
Arm Title
control
Arm Type
No Intervention
Arm Description
Abdominal layers will be closed without Infiltration .
Intervention Type
Drug
Intervention Name(s)
Intervention
Other Intervention Name(s)
local anesthetic infiltration
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self reported pain intensity upon receipt of a woman after cesarean section to the maternity department.
Description
Visual analogue scale pain severity with scale from 0 to 10, with score 10 representing the maximum level of pain.
Time Frame
up to 24 hours
Secondary Outcome Measure Information:
Title
Length of the cesarean section
Description
Time from first incision to the end of incision closure
Time Frame
up to 24 hours
Title
Time from surgery to mobility
Description
Time from the end of surgery to mobility
Time Frame
up to 48 hours
Title
Time from surgery to breastfeeding
Description
Time from the end of surgery to breastfeeding
Time Frame
up to 4 days
Title
Need for opioids
Description
Type and dosage of opioids needed
Time Frame
up to 4 days
Title
Surgical site hematoma
Description
Post operative surgical site hematoma
Time Frame
4 days
Title
surgical site infection
Description
Post operative surgical site infection
Time Frame
up to 42 days
Title
questionnaire
Description
Post operative women's satisfaction with scale from 0 to 10, with score 10 representing the maximum level of satisfaction.
Time Frame
up to 4 days
Title
Length of stay from surgery to discharge
Description
Length of stay from surgery to discharge
Time Frame
up to 4 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gali Garmi, MD
Organizational Affiliation
HaEmek Medical Center, Afula, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
HaEmek medical center
City
Afula
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
undecided
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Wound Infiltration With Bupivacaine/Adrenalin During Cesarean Section and Postoperative Pain.

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