Skip to main content
OpenTrials
Completed

NCT Number: NCT01751256

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postoperative Pain Anesthesia, Local Behavior Breast Feeding Feeding Behavior Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Poissy Saint Germain en Laye Hospital

Poissy, 78300, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous wound infiltration

Device

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 outcomes

  1. Postoperative morphine consumption

    Time frame: 24 first hours after cesarean section

    Quantity of morphine injected by the patient controlled analgesia pump

Secondary outcomes

  1. 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

    Numerical pain scale during mobilization

  2. Early walking

    Time frame: in the 72 first hours after skin closure

    Time taken for early walking

  3. Resumption of gastrointestinal function

    Time frame: First 72 hours after skin closure

    Interval from the end of surgery until the first gas from the intestinal tract

  4. Treatment tolerance

    Time frame: First 72 hours after skin closure

    Nausea, vomiting, pruritus, excessive sedation

  5. Maternal satisfaction

    Time frame: 2 days after skin closure

    Analogic numerical scale on a specific form

  6. Health staff workload

    Time frame: For the 48 first hours after skin closure

    Number of intervention for nursing, breastfeeding help, and cesarean wound dressing change

  7. Wound infections

    Time frame: the first 10 days after skin closure

    Number of wound infection needing specific cares appeared during the observation time

  8. Local anaesthetic systemic toxicity

    Time frame: During the first 48 hours after skin closure

    Every adverse effect attributed to local anaesthetic by an skilled anesthesiologist

  9. Discomfort due to material

    Time frame: At catheter retrieval

    Discomfort caused by the material and pain at retrieval of the catheter, assessed by an analogic scale on a specific form

  10. Technical problems related to the catheter

    Time frame: During the 48 first hours after skin closure

    Premature withdrawal or occlusion of the catheter

  11. 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

    Numerical pain scale at rest

  12. Comfort with Breast Feeding

    Time frame: For the the 48 first hours after skin closure

    Analogic numerical scale on a specific form

  13. All cause morbidity

    Time frame: For the first 10 days after skin closure

    Postpartum hemorrhage or every adverse event occurred during the observation period.

Sponsors and collaborators

Lead sponsor

Poissy-Saint Germain Hospital

Other

Registry information

Official study title

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

Acronym: KTcesar

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 17, 2012
Registry last updated
Dec 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.