Additional Effect of Wound Infiltration After Cesarean Section With Optimal Standard Analgesia

Study Overview
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Brief Summary
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The purpose of this study is to determine wether wound infiltration brings additional analgesia effect after cesarean section with optimal standard postoperative analgesia

Detailed Description
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Continuous wound infiltration with local anaesthetic has been shown as a safe and opioid-sparing analgesic method after caesarean section with minimal standard analgesia. We aim to evaluate if this benefit remains when an optimal analgesia is used. Primary outcome is morphine consumption. Secondary outcomes is pain scores, maternal recovery including breastfeeding, side effects of morphine, nurse workload and maternal satisfaction. Patients scheduled for caesarean delivery will be eligible for the study. Patients with emergency caesarean delivery, contraindication to analgesic drugs, hemostasis disorder, ongoing infection, diabetes treated with insulin or chronic opioid use will be excluded from the study. One group will receive standard analgesia including celecoxib and intravenous morphine for 24 hours with Patient Controlled Analgesia pump. The other group will receive the same standard analgesia with additional levobupivacaine initial bolus followed by a continuous subfascial infiltration of 1.25 mg/ml at 5 ml/h for 48 hours through a multiperforated catheter connected to an elastomeric pump. Total morphine consumption, pain and any associated complications will be recorded for 72 hours. Women wil be asked to fulfill a questionnaire on the second day after cesarean section, assessing recovery, satisfaction and breastfeeding comfort.

Official Title
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Levobupivacaine Continuous Wound Infiltration and Optimal Standard Analgesia Versus Optimal Standard Analgesia Alone After Cesarean Section.

Conditions
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Breast Feeding, Postoperative Pain, Anesthesia, Local

Intervention / Treatment
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* Device: Continuous wound infiltration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled cesarean section Exclusion Criteria: Emergency cesarean section Contraindication to opioids, paracetamol, or local anaesthetic Ongoing infection Coagulation disorders Diabetes treated with insulin Chronic opioid use

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous wound infiltration<br>Subfascial continuous wound infiltration with Levobupivacaine: bolus 50mg and 6.25mg/h for 48 hours through a multiperforated catheter, in addition to Celecoxib 200mg twice a day, paracetamol 1g four times a day, Nefopam 20mg four times a day, and intravenous morphine for 24 hours with Patient Controlled Analgesia pump (1.2mg by bolus, 7 minutes lockout period). | Device: Continuous wound infiltration<br>* Subfascial continuous wound infiltration with Levobupivacaine: bolus 50mg and 6.25mg/h for 48 hours through a multiperforated catheter, in addition to Celecoxib 200mg twice a day, paracetamol 1g four times a day, Nefopam 20mg four times a day, and intravenous morphine for 24 hours with Patient Controlled Analgesia pump (1.2mg by bolus, 7 minutes lockout period).<br>|
| No Intervention: Control<br>Celecoxib 200mg twice a day, paracetamol 1g four times a day, Nefopam 20mg four times a day, and intravenous morphine for 24 hours with Patient Controlled Analgesia pump (1.2mg by bolus, 7 minutes lockout period). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative morphine consumption | Quantity of morphine injected by the patient controlled analgesia pump | 24 first hours after cesarean section | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain at mobilization | Numerical pain scale during mobilization | 4, 8, 12, 16, 20, 24, 36, 48 and 78 hours after skin closure, entrance and exit from the recovery room | 
| Early walking | Time taken for early walking | in the 72 first hours after skin closure | 
| Resumption of gastrointestinal function | Interval from the end of surgery until the first gas from the intestinal tract | First 72 hours after skin closure | 
| Treatment tolerance | Nausea, vomiting, pruritus, excessive sedation | First 72 hours after skin closure | 
| Maternal satisfaction | Analogic numerical scale on a specific form | 2 days after skin closure | 
| Health staff workload | Number of intervention for nursing, breastfeeding help, and cesarean wound dressing change | For the 48 first hours after skin closure | 
| Wound infections | Number of wound infection needing specific cares appeared during the observation time | the first 10 days after skin closure | 
| Local anaesthetic systemic toxicity | Every adverse effect attributed to local anaesthetic by an skilled anesthesiologist | During the first 48 hours after skin closure | 
| Discomfort due to material | Discomfort caused by the material and pain at retrieval of the catheter, assessed by an analogic scale on a specific form | At catheter retrieval | 
| Technical problems related to the catheter | Premature withdrawal or occlusion of the catheter | During the 48 first hours after skin closure | 
| Pain at rest | Numerical pain scale at rest | 4, 8, 12, 16, 20, 24, 36, 48 and 78 hours after skin closure, entrance and exit from the recovery room | 
| Comfort with Breast Feeding | Analogic numerical scale on a specific form | For the the 48 first hours after skin closure | 
| All cause morbidity | Postpartum hemorrhage or every adverse event occurred during the observation period. | For the first 10 days after skin closure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postcesarean Section, Postoperative Pain, Care, Postoperative, Anesthesia, Local, Breast Feeding, Morphine, Pain Measurement, levobupivacaine