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

Sponsor

Poissy-Saint Germain Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01751256

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain Anesthesia, Local Breast Feeding	Device: Continuous wound infiltration	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2010

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

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).

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

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).

Outcome Measures

Primary Outcome Measures

Postoperative morphine consumption [24 first hours after cesarean section]
Quantity of morphine injected by the patient controlled analgesia pump

Secondary Outcome Measures

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