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Pre Operative Transversus Abdominis Plane Block Laparoscopic Gynecological Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gildasio De Oliveira, Northwestern University
ClinicalTrials.gov Identifier:
NCT01075074
First received: February 23, 2010
Last updated: April 2, 2013
Last verified: April 2013
History of Changes
Results First Received: March 6, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Prevention
Conditions: Pain
Surgery
Intervention: Procedure: Transversus abdominis plane block

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruited from Prentice Women's Hospital consecutively from 04/01/2010-02/2011

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
None

Reporting Groups
  Description
Ropivacaine 0.05% Subjects received a bilateral transversus abdominis plane block block using 15 cc of 0.5% ropivacaine
Normal Saline Subjects received a transversus abdominis plane block using 15 cc of sterile normal saline
Ropivacaine 0.25% Subjects received a bilateral transversus abdominis plane block using 15cc of ropivacaine 0.025%

Participant Flow:   Overall Study
    Ropivacaine 0.05%     Normal Saline     Ropivacaine 0.25%  
STARTED     25     25     25  
COMPLETED     24     23     23  
NOT COMPLETED     1     2     2  
Surgeon changed to open incisional case                 1                 2                 2  



  Baseline Characteristics
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Reporting Groups
  Description
Ropivacaine 0.05% Subjects received a bilateral transversus abdominis plane block block using 15 cc of 0.5% ropivacaine
Normal Saline Subjects received a transversus abdominis plane block using 15 cc of sterile normal saline
Ropivacaine 0.25% Subjects received a bilateral transversus abdominis plane block using 15cc of ropivacaine 0.025%
Total Total of all reporting groups

Baseline Measures
    Ropivacaine 0.05%     Normal Saline     Ropivacaine 0.25%     Total  
Number of Participants  
[units: participants]
 		  25     25     25     75  
Age  
[units: participants]
 		       
<=18 years     0     0     0     0  
Between 18 and 65 years     25     25     25     75  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  38  ± 8     38  ± 10     35  ± 9     37  ± 9  
Gender  
[units: participants]
 		       
Female     25     25     25     75  
Male     0     0     0     0  
Region of Enrollment  
[units: participants]
 		       
United States     25     25     25     75  



  Outcome Measures
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1.  Primary:   The Quality of Recovery Questionnaire (QoR40) on the Day (24 Hours) After Surgery   [ Time Frame: 24 hours after surgery ]
  Show Outcome Measure 1

2.  Secondary:   Pain Burden During Early Recovery From Anesthesia   [ Time Frame: Post Operative ]
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3.  Secondary:   Opioid Pain Medications Consumed During the First 24 Hours Post Surgery   [ Time Frame: 24 hours ]
  Show Outcome Measure 3

4.  Secondary:   Time to Hospital Discharge Readiness   [ Time Frame: 24 hours ]
  Show Outcome Measure 4


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
We did not obtain local anesthetic levels to compare safety profile. We were underpowered to detect a difference in the physical comfort dimension of the QOR questionnaire between the ropivacaine groups and the saline group.  


Results Point of Contact:  
Name/Title: Gildasio De Oliveira, MD
Organization: Northwestern University
phone: 312-926-8373
e-mail: g-jr@northwestern.edu


Publications:


Responsible Party: Gildasio De Oliveira, Northwestern University
ClinicalTrials.gov Identifier: NCT01075074     History of Changes
Other Study ID Numbers: STU00023475
Study First Received: February 23, 2010
Results First Received: March 6, 2012
Last Updated: April 2, 2013
Health Authority: United States: Institutional Review Board