N/A
Completed N=24
Evaluation of Addition of Dexamethasone to Transversus Abdominis Plane (TAP) Peripheral Nerve Block
Prostate CA
Source: ClinicalTrials.gov NCT01303003 ↗
Enrolled (actual)
24
Serious AEs
—
Results posted
Sep 2018
Primary outcomePrimary: Time to First Request of Additional Analgesia
Summary
Transversus abdominis plane (TAP) blocks are increasingly being performed after abdominal surgery to provide post operative analgesia. Dexamethasone has demonstrated an ability to prolong the effective duration of analgesia in several different peripheral nerve blocks. The study will examine, in a blinded, prospective and randomized fashion, whether the addition of dexamethasone to TAP blocks similarly prolongs blockade and pain relief. The study will compare local anesthetic with and without the addition of dexamethasone in the TAP block.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to First Request of Additional Analgesia |
— | — |
| SECONDARY Assess the Efficacy of the TAP Block by Measuring Visual Analog Scales, Total Opioid Use During the First 24 Hours Post-op, and Provider Assessments to Recognize the Overall Efficacy of the Procedure With and Without Dexamethasone Adjunct. |
— | — |
Eligibility Criteria
Inclusion Criteria
- Male patients, between ages 18-85 years old, undergoing Robot-assisted laparoscopic prostatectomy by a single surgeon at a single hospital.
- Subjects are physically and mentally able to participate in the study.
- Subjects are able to give fully informed consent to participating in this study after demonstrating good understanding of the risks and benefits of the proposed components of the TAP block.
Exclusion Criteria
- Demonstrated hypersensitivity or allergy to local anesthetics or dexamethasone.
- Any subject whose anatomy, or surgical procedure, in the opinion of the investigator, might preclude the potential successful performance of a TAP block.
- Any subject, who in the opinion of the investigator, might be harmed or be a poor candidate for participation in the study.
Data sourced from ClinicalTrials.gov (NCT01303003). 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. Informational only — not medical advice.