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

Postoperative Pain Clinical Trial

— KTcesar  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01751256
• Other study ID #: PoissyStGermainH
• Status: Completed
• Phase: Phase 4
• First received: December 13, 2012
• Last updated: December 14, 2012
• Start date: June 2010
• Est. completion date: December 2011

Study information

• Verified date: December 2012
• Source: Poissy-Saint Germain Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia, Local
• Breast Feeding
• Pain, Postoperative
• Postoperative Pain

Intervention

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).

Locations

Country	Name	City	State
France	Poissy Saint Germain en Laye Hospital	Poissy

Sponsors (1)

Lead Sponsor	Collaborator
Poissy-Saint Germain Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative morphine consumption	Quantity of morphine injected by the patient controlled analgesia pump	24 first hours after cesarean section	No
Secondary	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	No
Secondary	Early walking	Time taken for early walking	in the 72 first hours after skin closure	No
Secondary	Resumption of gastrointestinal function	Interval from the end of surgery until the first gas from the intestinal tract	First 72 hours after skin closure	No
Secondary	Treatment tolerance	Nausea, vomiting, pruritus, excessive sedation	First 72 hours after skin closure	Yes
Secondary	Maternal satisfaction	Analogic numerical scale on a specific form	2 days after skin closure	No
Secondary	Health staff workload	Number of intervention for nursing, breastfeeding help, and cesarean wound dressing change	For the 48 first hours after skin closure	No
Secondary	Wound infections	Number of wound infection needing specific cares appeared during the observation time	the first 10 days after skin closure	Yes
Secondary	Local anaesthetic systemic toxicity	Every adverse effect attributed to local anaesthetic by an skilled anesthesiologist	During the first 48 hours after skin closure	Yes
Secondary	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	Yes
Secondary	Technical problems related to the catheter	Premature withdrawal or occlusion of the catheter	During the 48 first hours after skin closure	Yes
Secondary	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	No
Secondary	Comfort with Breast Feeding	Analogic numerical scale on a specific form	For the the 48 first hours after skin closure	No
Secondary	All cause morbidity	Postpartum hemorrhage or every adverse event occurred during the observation period.	For the first 10 days after skin closure	Yes