Transversus Abdominis Plane (TAP) Block for Cesarean Section

Study Overview
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Brief Summary
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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
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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.

Official Title
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Transversus Abdominis Plane (TAP) Block for Cesarean Section

Conditions
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Hyperalgesia, Secondary

Intervention / Treatment
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* Drug: Bupivacaine Placebo
* Drug: Clonidine Placebo
* Drug: Bupivacaine
* Drug: Clonidine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Sterile Saline used for TAP block = Bupivacaine Placebo + Clonidine Placebo | Drug: Bupivacaine Placebo<br>* 2 x 20mL 0.9% NaCl<br>* Other names: Sodium Chloride;Drug: Clonidine Placebo<br>* 2 x 1mL 0.9% NaCl<br>* Other names: Sodium Chloride;|
| Active Comparator: TAP (Bupi)<br>2x20mL 0.375% Bupivacaine + 2x1mL of 0.9% NaCl = 150mg Bupivacaine + Clonidine Placebo | Drug: Clonidine Placebo<br>* 2 x 1mL 0.9% NaCl<br>* Other names: Sodium Chloride;Drug: Bupivacaine<br>* 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine<br>* Other names: Bupivacaine Hydrochloride;|
| Active Comparator: Clo-TAP (Bupi + Clon)<br>2x20mL 0.375% Bupivacaine + 2x1mL Clonidine = 150mg Bupivacaine + 150µg Clonidine | Drug: Bupivacaine<br>* 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine<br>* Other names: Bupivacaine Hydrochloride;Drug: Clonidine<br>* 2 x 1ml Clonidine = 150 µg Clonidine<br>* Other names: Clonidine Hydrochloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 48hrs after CS | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, postoperative, hyperalgesia, transversus abdominis plane block, TAP block, cesarean section