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
Enrollment 90
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo TAP (Bupi) Clo-TAP (Bupi + Clon)
Hide Arm/Group Description

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

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

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

Period Title: Overall Study
Started 30 30 30
Completed 30 30 30
Not Completed 0 0 0
Arm/Group Title Placebo TAP (Bupi) Clo-TAP (Bupi + Clon) Total
Hide Arm/Group Description

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

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

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 of all reporting groups
Overall Number of Baseline Participants 30 30 30 90
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 30 participants 90 participants
30.5  (6.7) 31.8  (4.5) 29.5  (6.7) 30  (5.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 30 participants 90 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%
1.Primary Outcome
Title Wound Hyperalgesia Index (WHA) Assessed 48 Hrs After Block Placement in the Different Groups
Hide Description Determine which of three different TAP formulations (Placebo, TAP, Clo-TAP) has the most beneficial effect on the postoperative area of hyperalgesia 48hrs after the start of the cesarean section. The smaller the area of WHA, assessed in cm2, the better the outcome. Area sizes may range from 0 to any size.
Time Frame 48hrs after CS
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo TAP (Bupi) Clo-TAP (Bupi + Clon)
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 30 30 30
Mean (Inter-Quartile Range)
Unit of Measure: cm^2
1.07
(0.48 to 3.26)
1.27
(0.59 to 2.95)
0.74
(0.09 to 2.25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, TAP (Bupi), Clo-TAP (Bupi + Clon)
Comments We estimated that 25 subjects per group would allow us to detect a reduction of this area from 7.5 cm2 in our placebo group to 3.5 cm2 in the CloTAP group, with SD = 5 cm2 in both groups, owing to improved overall analgesia and reduced pain sensitization in women allocated to receive a TAP block with clonidine (2-tailed [alpha] = 0.05, 80% power). To allow for failed TAP blocks and/or exclusions of cases, we included 30 patients per group (n = 90)
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.48
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo TAP (Bupi) Clo-TAP (Bupi + Clon)
Hide Arm/Group Description

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

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

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

All-Cause Mortality
Placebo TAP (Bupi) Clo-TAP (Bupi + Clon)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo TAP (Bupi) Clo-TAP (Bupi + Clon)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/30 (0.00%)      0/030 (0.00%)      0/30 (0.00%)    
Cardiac disorders       
LAST * [1]  0/30 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Local anesthetic systemic toxicity
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo TAP (Bupi) Clo-TAP (Bupi + Clon)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/30 (0.00%)      0/30 (0.00%)      0/30 (0.00%)    
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
EMail: 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