Evaluation of Addition of Dexamethasone to Transversus Abdominis Plane (TAP) Peripheral Nerve Block: Does it Enhance the Quality and Duration of Analgesia?
18 Years
85 Years
Male
Prostate CA
Trial Information
Evaluation of Addition of Dexamethasone to Transversus Abdominis Plane (TAP) Peripheral Nerve Block: Does it Enhance the Quality and Duration of Analgesia?
The study will be done in two phases. In the first phase, patients will be randomized to
receive either 20 cc of 0.125% bupivicaine with or without 2 mg of dexamethasone on each
side of their abdomen (40 cc and 4 mg in total) and patients who receive the dexamethasone
will be compared with patients who did not receive it. In the second phase, we will assess
whether patients can serve as their own controls by adding dexamethasone only to one side of
the block (one side of the abdomen) and comparing pain relief/efficacy with the
contra-lateral plain local anesthetic effect. The study will assess pain relief, opioid
consumption, level of blockade, and operator's prospective assessment of likely efficacy,
based on the ultrasound visualization of the local anesthetic injection as compared with
actual efficacy.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Outcome Measure:
Time to first request of additional analgesia
Outcome Description:
Documenting the time required by patients to the first request of additional analgesia.
Outcome Time Frame:
24 hours post-op
Safety Issue:
No
Principal Investigator
Andrew Sternlicht, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
St. Elizabeth's Medical Center of Boston
Authority:
United States: Institutional Review Board
Study ID:
TAP-00560
NCT ID:
NCT01303003
Start Date:
December 2010
Completion Date:
December 2011
Related Keywords:
- Prostate CA
- Prostatic Neoplasms
Name | Location |
|---|---|
| St. Elizabeth's Medical Center of Boston | Brighton, Massachusetts 02135 |
