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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cesarean Section

Intervention / Treatment
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* Drug: Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Infiltration of the subcutaneous layer with local anesthetic and combined with adrenaline. | Drug: Intervention<br>* 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.<br>* Other names: local anesthetic infiltration;|
| No Intervention: control<br>Abdominal layers will be closed without Infiltration . | |

What is the study measuring?
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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. | 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 from first incision to the end of incision closure | up to 24 hours | 
| Time from surgery to mobility | Time from the end of surgery to mobility | up to 48 hours | 
| Time from surgery to breastfeeding | Time from the end of surgery to breastfeeding | up to 4 days | 
| Need for opioids | Type and dosage of opioids needed | up to 4 days | 
| Surgical site hematoma | Post operative surgical site hematoma | 4 days | 
| surgical site infection | Post operative surgical site infection | up to 42 days | 
| questionnaire | 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 | Length of stay from surgery to discharge | up to 4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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local anesthetics infiltration, cesarean section pain relief