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Wound Infusion vs Spinal Morphine for Post-caesarean Analgesia (Apcisaal)

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ClinicalTrials.gov Identifier: NCT02264821
Recruitment Status : Completed
First Posted : October 15, 2014
Results First Posted : June 9, 2015
Last Update Posted : June 9, 2015
Sponsor:
Information provided by (Responsible Party):
Dr Madeleine Wilwerth, Brugmann University Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Post Caesarean Analgesia
Interventions: Drug: ropivacaine infiltration
Drug: intrathecal morphine
Drug: placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ropivacaine Infiltration

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

ropivacaine infiltration: wound infiltration

Rachi Morphine

100 µg intrathecal morphine and saline infiltration

intrathecal morphine: 100 µg added to the spinal anaesthesia

Placebo

intrathecal saline and saline infiltration

placebo: placebo in spinal anaesthesia and in wound infiltration


Participant Flow:   Overall Study
    Ropivacaine Infiltration   Rachi Morphine   Placebo
STARTED   64 [1]   64 [1]   64 [1] 
COMPLETED   63   61   58 
NOT COMPLETED   1   3   6 
Protocol Violation                1                3                6 
[1] Double Blind



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Ropivacaine Infiltration

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

ropivacaine infiltration: wound infiltration

Rachi Morphine

100 µg intrathecal morphine and saline infiltration

intrathecal morphine: 100 µg added to the spinal anaesthesia

Placebo

intrathecal saline and saline infiltration

placebo: placebo in spinal anaesthesia and in wound infiltration

Total Total of all reporting groups

Baseline Measures
   Ropivacaine Infiltration   Rachi Morphine   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 63   61   58   182 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 30 
 (27 to 34) 
 32 
 (28 to 34) 
 32 
 (28 to 37) 
 32 
 (27 to 37) 
Gender 
[Units: Participants]
       
Female   63   61   58   182 
Male   0   0   0   0 
Region of Enrollment 
[Units: Participants]
       
Belgium   63   61   58   182 


  Outcome Measures

1.  Primary:   Duration of Effective Analgesia   [ Time Frame: 30 hours after spinal injection T0 ]

2.  Primary:   Morphine Consumption   [ Time Frame: 30 hours after spinal injection T0 ]

3.  Secondary:   Incidence of Morphine Side Effects: Nausea, Vomiting, Pruritus.   [ Time Frame: 30 hours after spinal injection ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr Madeleine Wilwerth
Organization: CHU Brugmann
phone: 003224773996
e-mail: madeleine.wilwerth@chu-brugmann.be



Responsible Party: Dr Madeleine Wilwerth, Brugmann University Hospital
ClinicalTrials.gov Identifier: NCT02264821     History of Changes
Other Study ID Numbers: Apcisaal 01
First Submitted: August 25, 2014
First Posted: October 15, 2014
Results First Submitted: April 22, 2015
Results First Posted: June 9, 2015
Last Update Posted: June 9, 2015