ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 2 for:    14674981 [PUBMED-IDS]

Transversus Abdominis Plane (TAP) Block for Cesarean Section (CLOTAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01015807
Recruitment Status : Completed
First Posted : November 18, 2009
Results First Posted : May 30, 2017
Last Update Posted : October 23, 2017
Sponsor:
Information provided by (Responsible Party):
Laurent Bollag, University of Washington

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Prevention
Condition: Hyperalgesia, Secondary
Interventions: Drug: Bupivacaine Placebo
Drug: Clonidine Placebo
Drug: Bupivacaine
Drug: Clonidine

  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
Placebo

Sterile Saline used for TAP block = Bupivacaine Placebo + Clonidine Placebo

Bupivacaine Placebo: 2 x 20mL 0.9% NaCl

Clonidine Placebo: 2 x 1mL 0.9% NaCl

TAP (Bupi)

2x20mL 0.375% Bupivacaine + 2x1mL of 0.9% NaCl = 150mg Bupivacaine + Clonidine Placebo

Clonidine Placebo: 2 x 1mL 0.9% NaCl

Bupivacaine: 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine

Clo-TAP (Bupi + Clon)

2x20mL 0.375% Bupivacaine + 2x1mL Clonidine = 150mg Bupivacaine + 150µg Clonidine

Bupivacaine: 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine

Clonidine: 2 x 1ml Clonidine = 150 µg Clonidine


Participant Flow:   Overall Study
    Placebo   TAP (Bupi)   Clo-TAP (Bupi + Clon)
STARTED   30   30   30 
COMPLETED   30   30   30 
NOT COMPLETED   0   0   0 



  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
Placebo

Sterile Saline used for TAP block = Bupivacaine Placebo + Clonidine Placebo

Bupivacaine Placebo: 2 x 20mL 0.9% NaCl

Clonidine Placebo: 2 x 1mL 0.9% NaCl

TAP (Bupi)

2x20mL 0.375% Bupivacaine + 2x1mL of 0.9% NaCl = 150mg Bupivacaine + Clonidine Placebo

Clonidine Placebo: 2 x 1mL 0.9% NaCl

Bupivacaine: 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine

Clo-TAP (Bupi + Clon)

2x20mL 0.375% Bupivacaine + 2x1mL Clonidine = 150mg Bupivacaine + 150µg Clonidine

Bupivacaine: 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine

Clonidine: 2 x 1ml Clonidine = 150 µg Clonidine

Total Total of all reporting groups

Baseline Measures
   Placebo   TAP (Bupi)   Clo-TAP (Bupi + Clon)   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   30   30   90 
Age 
[Units: Years]
Mean (Standard Deviation)
 30.5  (6.7)   31.8  (4.5)   29.5  (6.7)   30  (5.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      30 100.0%      30 100.0%      30 100.0%      90 100.0% 
Male      0   0.0%      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures

1.  Primary:   Wound Hyperalgesia Index (WHA) Assessed 48 Hrs After Block Placement in the Different Groups   [ Time Frame: 48hrs after CS ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Laurent Bollag
Organization: Univerisity of Washington
phone: +12063277328
e-mail: bollag@uw.edu


Publications:


Responsible Party: Laurent Bollag, University of Washington
ClinicalTrials.gov Identifier: NCT01015807     History of Changes
Other Study ID Numbers: 36707
First Submitted: November 16, 2009
First Posted: November 18, 2009
Results First Submitted: December 2, 2014
Results First Posted: May 30, 2017
Last Update Posted: October 23, 2017