N/A
N=90
Transversus Abdominis Plane (TAP) Block for Cesarean Section
Hyperalgesia, Secondary
Bottom Line
View on ClinicalTrials.gov: NCT01015807 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Wound Hyperalgesia Index (WHA) Assessed 48 Hrs After Block Placement in the Different Groups — 1.07; 1.27; 0.74 cm^2 — p=0.48
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bupivacaine Placebo (Drug); Clonidine Placebo (Drug); Bupivacaine (Drug); Clonidine (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Washington
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Wound Hyperalgesia Index (WHA) Assessed 48 Hrs After Block Placement in the Different Groups |
1.07; 1.27; 0.74 | 0.48 |
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.
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
Data sourced from ClinicalTrials.gov (NCT01015807). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.