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Evaluation of Addition of Dexamethasone to Transversus Abdominis Plane (TAP) Peripheral Nerve Block

Not Applicable
Completed
Conditions
Prostate CA
Interventions
Procedure: TAP block
Registration Number
NCT01303003
Lead Sponsor
Steward St. Elizabeth's Medical Center of Boston, Inc.
Brief 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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
24
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Treatment Arm 2TAP blockBilateral TAP block of 40cc. of 0.125% bupivicaine + 0.5cc. sterile saline per side
Treatment Arm 1DexamethasoneBilateral TAP block consisting of 40cc. 0.125% bupivicaine + 0.5cc. dexamethasone (2mg.) per side.
Primary Outcome Measures
NameTimeMethod
Time to First Request of Additional Analgesia24 hours post-op

Documenting the time required by patients to the first request of additional analgesia.

Secondary Outcome Measures
NameTimeMethod
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.24 hours post-op

Trial Locations

Locations (1)

St. Elizabeth's Medical Center of Boston

🇺🇸

Boston, Massachusetts, United States

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