Transversus Abdominis Plane (TAP) Block for Cesarean Section

Not Applicable

Completed

• Conditions: Hyperalgesia, Secondary
• Interventions: Drug: Clonidine Placebo; Drug: Bupivacaine Placebo; Drug: Bupivacaine; Drug: Clonidine

• Registration Number: NCT01015807
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-16
• Study First Submitted QC: 2009-11-16
• Study First Posted: 2009-11-18
• Primary Completion: 2010-08
• Study Completion: 2012-08
• Results First Submitted: 2014-12-02
• Results First Submitted QC: 2017-05-04
• Results First Posted: 2017-05-30
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-21
• Last Update Posted: 2017-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAP (Bupi)	Clonidine Placebo	2x20mL 0.375% Bupivacaine + 2x1mL of 0.9% NaCl = 150mg Bupivacaine + Clonidine Placebo
Placebo	Bupivacaine Placebo	Sterile Saline used for TAP block = Bupivacaine Placebo + Clonidine Placebo
Placebo	Clonidine Placebo	Sterile Saline used for TAP block = Bupivacaine Placebo + Clonidine Placebo
TAP (Bupi)	Bupivacaine	2x20mL 0.375% Bupivacaine + 2x1mL of 0.9% NaCl = 150mg Bupivacaine + Clonidine Placebo
Clo-TAP (Bupi + Clon)	Bupivacaine	2x20mL 0.375% Bupivacaine + 2x1mL Clonidine = 150mg Bupivacaine + 150µg Clonidine
Clo-TAP (Bupi + Clon)	Clonidine	2x20mL 0.375% Bupivacaine + 2x1mL Clonidine = 150mg Bupivacaine + 150µg Clonidine

Primary Outcome Measures

Name	Time	Method
Wound Hyperalgesia Index (WHA) Assessed 48 Hrs After Block Placement in the Different Groups	48hrs after CS	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.

Trial Locations

Locations (2)

University of Washington; 🇺🇸 Seattle, Washington, United States

Hospital e Maternidade Santa Joana; 🇧🇷 São Paulo, Brazil