Title

Wound Infusion vs Spinal Morphine for Post-caesarean Analgesia
Is Continuous Wound Infusion With Ropivacaine Better Than Intrathecal Morphine for Post-caesarean Analgesia? A Prospective, Randomized, Controlled, Double Blinded Study
  • Phase

    Phase 3
  • Study Type

    Interventional
  • Intervention/Treatment

    ropivacaine morphine ...
  • Study Participants

    192
The aim of this study is to compare effective analgesia with continuous wound infiltration of ropivacaine through multi-holed catheter or with morphine 100 mcg added intrathecally to spinal anesthesia, after elective Caesarean delivery.
Double blind, 3 groups

Control group: Rachi 0,1 ml saline, Infusion 300ml saline
Group rachi-morphine: 0,1ml =100µg morphine/300ml saline
Group KT: 0,1 ml saline/300 ml naropin 0.2%
Study Started
Feb 29
2012
Primary Completion
Aug 31
2014
Study Completion
Aug 31
2014
Results Posted
Jun 09
2015
Estimate
Last Update
Jun 09
2015
Estimate

Drug ropivacaine infiltration

wound infiltration

  • Other names: Naropin, local anesthetic

Drug intrathecal morphine

100 µg added to the spinal anaesthesia

  • Other names: spinal morphine

Drug placebo

placebo in spinal anaesthesia and in wound infiltration

  • Other names: Nacl 0,9 %, saline solution

ropivacaine infiltration Experimental

ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline

rachi morphine Experimental

100 µg intrathecal morphine and saline infiltration

placebo Placebo Comparator

intrathecal saline and saline infiltration

Criteria

Inclusion Criteria:

Patients aged 18 years and more, ASA 1 or ASA 2, pregnant with at least 34 weeks of gestational age, admitted for a planned caesarian with a Pfannenstiel incision and having signed the informed consent form.

Exclusion Criteria:

Refusal of the patient or contra-indication to locoregional anesthesia
Allergy to the products used
ASA 3
ASA 4
Sleep apnea syndrome and/or obesity (BMI > 35)
Size inferior to 155cm
existence of a language barrier

Summary

Ropivacaine Infiltration

Rachi Morphine

Placebo

All Events

Event Type Organ System Event Term Ropivacaine Infiltration Rachi Morphine Placebo

Duration of Effective Analgesia

T0 until first request of morphine PCAIV

Ropivacaine Infiltration

351.0
minutes (Median)
Inter-Quartile Range: 227.0 to 594.0

Rachi Morphine

380.0
minutes (Median)
Inter-Quartile Range: 215.0 to 1527.0

Placebo

247.0
minutes (Median)
Inter-Quartile Range: 182.0 to 338.0

Morphine Consumption

Morphine consumption with PCAIV

Ropivacaine Infiltration

8.0
milligrammes (Median)
Inter-Quartile Range: 4.0 to 20.0

Rachi Morphine

4.0
milligrammes (Median)
Inter-Quartile Range: 1.0 to 10.0

Placebo

20.5
milligrammes (Median)
Inter-Quartile Range: 9.5 to 31.0

Incidence of Morphine Side Effects: Nausea, Vomiting, Pruritus.

Is there a decrease of the incidence of morphine side effects such as nausea, vomiting, pruritus?

Outcome Measure Data Not Reported

Total

182
Participants

Age, Continuous

32
years (Median)
Inter-Quartile Range: 27.0 to 37.0

Region of Enrollment

Sex: Female, Male

Overall Study

Ropivacaine Infiltration

Rachi Morphine

Placebo

Drop/Withdrawal Reasons

Ropivacaine Infiltration

Rachi Morphine

Placebo