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

• Postoperative morphine consumption [ Time Frame: 24 first hours after cesarean section ] [ Designated as safety issue: No ]
  Quantity of morphine injected by the patient controlled analgesia pump
  
  

• Pain at mobilization [ Time Frame: 4, 8, 12, 16, 20, 24, 36, 48 and 78 hours after skin closure, entrance and exit from the recovery room ] [ Designated as safety issue: No ]
  Numerical pain scale during mobilization
  
  
• Early walking [ Time Frame: in the 72 first hours after skin closure ] [ Designated as safety issue: No ]
  Time taken for early walking
  
  
• Resumption of gastrointestinal function [ Time Frame: First 72 hours after skin closure ] [ Designated as safety issue: No ]
  Interval from the end of surgery until the first gas from the intestinal tract
  
  
• Treatment tolerance [ Time Frame: First 72 hours after skin closure ] [ Designated as safety issue: Yes ]
  Nausea, vomiting, pruritus, excessive sedation
  
  
• Maternal satisfaction [ Time Frame: 2 days after skin closure ] [ Designated as safety issue: No ]
  Analogic numerical scale on a specific form
  
  
• Health staff workload [ Time Frame: For the 48 first hours after skin closure ] [ Designated as safety issue: No ]
  Number of intervention for nursing, breastfeeding help, and cesarean wound dressing change
  
  
• Wound infections [ Time Frame: the first 10 days after skin closure ] [ Designated as safety issue: Yes ]
  Number of wound infection needing specific cares appeared during the observation time
  
  
• Local anaesthetic systemic toxicity [ Time Frame: During the first 48 hours after skin closure ] [ Designated as safety issue: Yes ]
  Every adverse effect attributed to local anaesthetic by an skilled anesthesiologist
  
  
• Discomfort due to material [ Time Frame: At catheter retrieval ] [ Designated as safety issue: Yes ]
  Discomfort caused by the material and pain at retrieval of the catheter, assessed by an analogic scale on a specific form
  
  
• Technical problems related to the catheter [ Time Frame: During the 48 first hours after skin closure ] [ Designated as safety issue: Yes ]
  Premature withdrawal or occlusion of the catheter
  
  
• Pain at rest [ Time Frame: 4, 8, 12, 16, 20, 24, 36, 48 and 78 hours after skin closure, entrance and exit from the recovery room ] [ Designated as safety issue: No ]
  Numerical pain scale at rest
  
  
• Comfort with Breast Feeding [ Time Frame: For the the 48 first hours after skin closure ] [ Designated as safety issue: No ]
  Analogic numerical scale on a specific form
  
  
• All cause morbidity [ Time Frame: For the first 10 days after skin closure ] [ Designated as safety issue: Yes ]
  Postpartum hemorrhage or every adverse event occurred during the observation period.
  
  

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.