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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Claude JOLLY, Poissy-Saint Germain Hospital
ClinicalTrials.gov Identifier:
NCT01751256
First received: December 13, 2012
Last updated: December 14, 2012
Last verified: December 2012
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Levobupivacaine Continuous Wound Infiltration and Optimal Standard Analgesia Versus Optimal Standard Analgesia Alone After Cesarean Section.

Resource links provided by NLM:


Further study details as provided by Poissy-Saint Germain Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 68
Study Start Date: June 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01751256

Locations
France
Poissy Saint Germain en Laye Hospital
Poissy, France, 78300
Sponsors and Collaborators
Poissy-Saint Germain Hospital
Investigators
Principal Investigator: Claude JOLLY, MD Poissy-Saint Germain Hospital
  More Information

No publications provided

Responsible Party: Claude JOLLY, MD, Poissy-Saint Germain Hospital
ClinicalTrials.gov Identifier: NCT01751256     History of Changes
Other Study ID Numbers: PoissyStGermainH
Study First Received: December 13, 2012
Last Updated: December 14, 2012
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Poissy-Saint Germain Hospital:
Postcesarean Section
Postoperative Pain
Care, Postoperative
Anesthesia, Local
Breast Feeding
Morphine
Pain Measurement
levobupivacaine

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Levobupivacaine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014