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

Primary Purpose

Postoperative Pain, Anesthesia, Local, Breast Feeding

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Continuous wound infiltration
Sponsored by
Poissy-Saint Germain Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Postcesarean Section, Postoperative Pain, Care, Postoperative, Anesthesia, Local, Breast Feeding, Morphine, Pain Measurement, levobupivacaine

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Poissy Saint Germain en Laye Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Continuous wound infiltration

Control

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Postoperative morphine consumption
Quantity of morphine injected by the patient controlled analgesia pump

Secondary Outcome Measures

Pain at mobilization
Numerical pain scale during mobilization
Early walking
Time taken for early walking
Resumption of gastrointestinal function
Interval from the end of surgery until the first gas from the intestinal tract
Treatment tolerance
Nausea, vomiting, pruritus, excessive sedation
Maternal satisfaction
Analogic numerical scale on a specific form
Health staff workload
Number of intervention for nursing, breastfeeding help, and cesarean wound dressing change
Wound infections
Number of wound infection needing specific cares appeared during the observation time
Local anaesthetic systemic toxicity
Every adverse effect attributed to local anaesthetic by an skilled anesthesiologist
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
Technical problems related to the catheter
Premature withdrawal or occlusion of the catheter
Pain at rest
Numerical pain scale at rest
Comfort with Breast Feeding
Analogic numerical scale on a specific form
All cause morbidity
Postpartum hemorrhage or every adverse event occurred during the observation period.

Full Information

First Posted
December 13, 2012
Last Updated
December 14, 2012
Sponsor
Poissy-Saint Germain Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01751256
Brief Title
Additional Effect of Wound Infiltration After Cesarean Section With Optimal Standard Analgesia
Acronym
KTcesar
Official Title
Levobupivacaine Continuous Wound Infiltration and Optimal Standard Analgesia Versus Optimal Standard Analgesia Alone After Cesarean Section.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Poissy-Saint Germain Hospital

4. Oversight

Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Anesthesia, Local, Breast Feeding
Keywords
Postcesarean Section, Postoperative Pain, Care, Postoperative, Anesthesia, Local, Breast Feeding, Morphine, Pain Measurement, levobupivacaine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuous wound infiltration
Arm Type
Experimental
Arm Description
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).
Arm Title
Control
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Continuous wound infiltration
Intervention Description
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).
Primary Outcome Measure Information:
Title
Postoperative morphine consumption
Description
Quantity of morphine injected by the patient controlled analgesia pump
Time Frame
24 first hours after cesarean section
Secondary Outcome Measure Information:
Title
Pain at mobilization
Description
Numerical pain scale during mobilization
Time Frame
4, 8, 12, 16, 20, 24, 36, 48 and 78 hours after skin closure, entrance and exit from the recovery room
Title
Early walking
Description
Time taken for early walking
Time Frame
in the 72 first hours after skin closure
Title
Resumption of gastrointestinal function
Description
Interval from the end of surgery until the first gas from the intestinal tract
Time Frame
First 72 hours after skin closure
Title
Treatment tolerance
Description
Nausea, vomiting, pruritus, excessive sedation
Time Frame
First 72 hours after skin closure
Title
Maternal satisfaction
Description
Analogic numerical scale on a specific form
Time Frame
2 days after skin closure
Title
Health staff workload
Description
Number of intervention for nursing, breastfeeding help, and cesarean wound dressing change
Time Frame
For the 48 first hours after skin closure
Title
Wound infections
Description
Number of wound infection needing specific cares appeared during the observation time
Time Frame
the first 10 days after skin closure
Title
Local anaesthetic systemic toxicity
Description
Every adverse effect attributed to local anaesthetic by an skilled anesthesiologist
Time Frame
During the first 48 hours after skin closure
Title
Discomfort due to material
Description
Discomfort caused by the material and pain at retrieval of the catheter, assessed by an analogic scale on a specific form
Time Frame
At catheter retrieval
Title
Technical problems related to the catheter
Description
Premature withdrawal or occlusion of the catheter
Time Frame
During the 48 first hours after skin closure
Title
Pain at rest
Description
Numerical pain scale 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
Title
Comfort with Breast Feeding
Description
Analogic numerical scale on a specific form
Time Frame
For the the 48 first hours after skin closure
Title
All cause morbidity
Description
Postpartum hemorrhage or every adverse event occurred during the observation period.
Time Frame
For the first 10 days after skin closure

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claude JOLLY, MD
Organizational Affiliation
Poissy-Saint Germain Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Poissy Saint Germain en Laye Hospital
City
Poissy
ZIP/Postal Code
78300
Country
France

12. IPD Sharing Statement

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

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