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

Primary Purpose

Hyperalgesia, Secondary

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Bupivacaine Placebo
Clonidine Placebo
Bupivacaine
Clonidine
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hyperalgesia, Secondary focused on measuring postoperative, hyperalgesia, pain, transversus abdominis plane block, TAP block, cesarean section

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • non-laboring women who will benefit from and have clinically consented to a scheduled or non-scheduled cesarean delivery under spinal anesthesia
  • English speaking (UW Site) or Portuguese speaking (Brazil site)
  • aged between 18 and 45 years
  • BMI < 40
  • ASA physical status class I or II

Exclusion Criteria:

  • laboring women undergoing a non-scheduled cesarean delivery
  • non-English speaking (UW Site) or non-Portuguese speaking (Brazil site)
  • previous spinal surgery
  • contraindications for neuraxial anesthesia
  • allergy to local anesthetic, ultrasound conduction gel, or Clonidine
  • history of chronic pain
  • inability to receive intraoperative Toradol

Sites / Locations

  • University of Washington
  • Hospital e Maternidade Santa Joana

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Placebo

TAP (Bupi)

Clo-TAP (Bupi + Clon)

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Wound Hyperalgesia Index (WHA) Assessed 48 Hrs After Block Placement in the Different Groups
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.

Secondary Outcome Measures

Full Information

First Posted
November 16, 2009
Last Updated
September 21, 2017
Sponsor
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT01015807
Brief Title
Transversus Abdominis Plane (TAP) Block for Cesarean Section
Acronym
CLOTAP
Official Title
Transversus Abdominis Plane (TAP) Block for Cesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether a transversus abdominis plane (TAP) block with Clonidine added to the injectate (Clo-TAP) performed approximately 2hrs after the cesarean section (CS) will decrease the amount of postoperative hyperalgesia and ultimately reduce post-CS chronic pain.
Detailed Description
Acute severe pain after cesarean section (CS) occurs more often than is thought and 10-15% of the women having a cesarean section develop chronic pain (Kehlet et al. 2006). With over 1.3 million cesarean deliveries per year in the US, this is bound to create a significant health problem. One way to address this health burden is to refine techniques that may help control the pain women experience after CS and ultimately reduce the potential to develop chronic pain. The purpose of this randomized, double-blinded study is to evaluate the ability of an established anesthetic technique called the transversus abdominis plane (TAP) block to reduce the amount of hyperalgesia women develop around their incision after CS. Measuring the amount of punctuate mechanical hyperalgesia is used as a tool to assess postoperative central sensitization (Lavand'homme et al. 2005), which contributes to postoperative acute pain. Since postoperative acute pain has been shown to be predictive of developing postoperative chronic pain (Eisenach et al. 2008; Yarnitsky et al. 2008), an effective TAP block could help diminish the incidence of chronic pain after CS. In addition, blood samples will be collected for future genetic analysis and we will test preoperatively for mechanical temporal summation (mTS) to evaluate CNS (central nervous system) sensitization and nociceptive system hyperexcitability and see if this correlates with the amount of hyperalgesia women develop around their incision after surgery. The primary aim of this study is to evaluate the benefits of two different solutions injected by TAP block technique on postoperative peri-incisional hyperalgesia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperalgesia, Secondary
Keywords
postoperative, hyperalgesia, pain, transversus abdominis plane block, TAP block, cesarean section

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Sterile Saline used for TAP block = Bupivacaine Placebo + Clonidine Placebo
Arm Title
TAP (Bupi)
Arm Type
Active Comparator
Arm Description
2x20mL 0.375% Bupivacaine + 2x1mL of 0.9% NaCl = 150mg Bupivacaine + Clonidine Placebo
Arm Title
Clo-TAP (Bupi + Clon)
Arm Type
Active Comparator
Arm Description
2x20mL 0.375% Bupivacaine + 2x1mL Clonidine = 150mg Bupivacaine + 150µg Clonidine
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Placebo
Other Intervention Name(s)
Bupi Placebo, Sodium Chloride
Intervention Description
2 x 20mL 0.9% NaCl
Intervention Type
Drug
Intervention Name(s)
Clonidine Placebo
Other Intervention Name(s)
Sodium Chloride
Intervention Description
2 x 1mL 0.9% NaCl
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Bupivacaine Hydrochloride
Intervention Description
2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine
Intervention Type
Drug
Intervention Name(s)
Clonidine
Other Intervention Name(s)
Clonidine Hydrochloride
Intervention Description
2 x 1ml Clonidine = 150 µg Clonidine
Primary Outcome Measure Information:
Title
Wound Hyperalgesia Index (WHA) Assessed 48 Hrs After Block Placement in the Different Groups
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: non-laboring women who will benefit from and have clinically consented to a scheduled or non-scheduled cesarean delivery under spinal anesthesia English speaking (UW Site) or Portuguese speaking (Brazil site) aged between 18 and 45 years BMI < 40 ASA physical status class I or II Exclusion Criteria: laboring women undergoing a non-scheduled cesarean delivery non-English speaking (UW Site) or non-Portuguese speaking (Brazil site) previous spinal surgery contraindications for neuraxial anesthesia allergy to local anesthetic, ultrasound conduction gel, or Clonidine history of chronic pain inability to receive intraoperative Toradol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruth Landau, MD
Organizational Affiliation
University of Washington
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Laurent Bollag, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Hospital e Maternidade Santa Joana
City
São Paulo
ZIP/Postal Code
04103-080
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
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Transversus Abdominis Plane (TAP) Block for Cesarean Section

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