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

University of Washington

Status: Completed

Conditions: Hyperalgesia, Secondary

Treatments: Drug: Clonidine Placebo; Drug: Bupivacaine Placebo; Drug: Bupivacaine; Drug: Clonidine

Study type: Interventional

Funder types: Other

Identifiers

NCT01015807

36707

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Bupivacaine Placebo

Drug: Clonidine Placebo

TAP (Bupi)

Active Comparator group

Description:

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

Treatment:

Drug: Bupivacaine

Drug: Clonidine Placebo

Clo-TAP (Bupi + Clon)

Active Comparator group

Description:

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

Treatment:

Drug: Clonidine

Drug: Bupivacaine