Transversus Abdominis Plane (TAP) Block for Cesarean Section
Information source: University of Washington
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hyperalgesia, Secondary
Intervention: Bupivacaine Placebo (Drug); Clonidine Placebo (Drug); Bupivacaine (Drug); Clonidine (Drug)
Phase: N/A
Status: Terminated
Sponsored by: University of Washington Official(s) and/or principal investigator(s): Ruth Landau, MD, Study Chair, Affiliation: University of Washington Laurent Bollag, MD, Principal Investigator, Affiliation: University of Washington
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.
Clinical Details
Official title: Transversus Abdominis Plane (TAP) Block for Cesarean Section
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention
Primary outcome: To 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.
Secondary outcome: To determine which of three different TAP formulations has the most beneficial effect on the postoperative area of hyperalgesia 24 hrs after the start of the CSTo determine which of the three different TAP groups has the most beneficial effect on the postoperative amount of static hyperalgesia 24 and 48hrs after the start of the CS To evaluate pain scores at rest and during movement at 6, 12, 18, 24, 36 and 48hrs after the surgery To evaluate the time it takes for a woman to ask for the first analgesic medication after the surgery To evaluate postoperative morphine consumption (or equivalent of morphine) during the first 48hrs after the surgery To evaluate the correlation between preoperative mechanical temporal summation (mTS) and amount of hyperalgesia and postoperative pain To evaluate postoperative side effects such as postoperative nausea and vomiting (PONV), constipation, urinary retention, de-ambulation and motricity To evaluate chronic pain at 3, 6 and 12 months post-surgery by phone with the Short-Form McGill Pain Questionnaire 2 (SF-MPQ-2) To study selected candidate genes related to postoperative pain and analgesics
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
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
- 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
- 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
Locations and Contacts
University of Washington, Seattle, Washington 98195, United States
Additional Information
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Starting date: November 2009
Last updated: September 20, 2013
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