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Completed

NCT Number: NCT03395912

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

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.

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Key information

Conditions

Cesarean Section

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

HaEmek medical center

Afula, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention

Drug

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

Primary outcomes

  1. 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

  1. Length of the cesarean section

    Time frame: up to 24 hours

    Time from first incision to the end of incision closure

  2. Time from surgery to mobility

    Time frame: up to 48 hours

    Time from the end of surgery to mobility

  3. Time from surgery to breastfeeding

    Time frame: up to 4 days

    Time from the end of surgery to breastfeeding

  4. Need for opioids

    Time frame: up to 4 days

    Type and dosage of opioids needed

  5. Surgical site hematoma

    Time frame: 4 days

    Post operative surgical site hematoma

  6. surgical site infection

    Time frame: up to 42 days

    Post operative surgical site infection

  7. 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.

  8. Length of stay from surgery to discharge

    Time frame: up to 4 days

    Length of stay from surgery to discharge

Sponsors and collaborators

Lead sponsor

HaEmek Medical Center, Israel

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Jan 10, 2018
Registry last updated
Oct 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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