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

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

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

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Anesthesia, Local; Breast Feeding
• Intervention / Treatment: Device: Continuous wound infiltration

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Poissy, France, 78300
    • Poissy Saint Germain en Laye Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Continuous wound infiltration; 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; 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).
No Intervention: Control; 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?

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

Collaborators and Investigators

• Sponsor: Poissy-Saint Germain Hospital
• Investigators: Principal Investigator: Claude JOLLY, MD, Poissy-Saint Germain Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: December 13, 2012
• First Submitted That Met QC Criteria: December 14, 2012
• First Posted (Estimate): December 17, 2012

Study Record Updates

• Last Update Posted (Estimate): December 17, 2012
• Last Update Submitted That Met QC Criteria: December 14, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Postoperative Pain; Breast Feeding; Morphine; levobupivacaine; Pain Measurement; Anesthesia, Local; Postcesarean Section; Care, Postoperative
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: PoissyStGermainH