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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Steward St. Elizabeth's Medical Center of Boston, Inc.
ClinicalTrials.gov Identifier:
NCT01303003
First received: February 23, 2011
Last updated: June 7, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Prostate CA
Drug: Dexamethasone
Procedure: TAP block

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Addition of Dexamethasone to Transversus Abdominis Plane (TAP) Peripheral Nerve Block: Does it Enhance the Quality and Duration of Analgesia?

Resource links provided by NLM:


Further study details as provided by Steward St. Elizabeth's Medical Center of Boston, Inc.:

Primary Outcome Measures:
  • Time to first request of additional analgesia [ Time Frame: 24 hours post-op ] [ Designated as safety issue: No ]
    Documenting the time required by patients to the first request of additional analgesia.


Secondary Outcome Measures:
  • 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. [ Time Frame: 24 hours post-op ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: December 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Arm 1
Bilateral TAP block consisting of 40cc. 0.125% bupivicaine + 0.5cc. dexamethasone (2mg.) per side.
Drug: Dexamethasone
40 cc. 0.125% bupivicaine + 0.5cc. dexamethasone (2mg.) per side.
Active Comparator: Treatment Arm 2
Bilateral TAP block of 40cc. of 0.125% bupivicaine + 0.5cc. sterile saline per side
Procedure: TAP block
Bilateral TAP block of 40cc. of 0.125% bupivicaine + 0.5cc. sterile saline per side

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01303003

Locations
United States, Massachusetts
St. Elizabeth's Medical Center of Boston
Boston, Massachusetts, United States, 02135
Sponsors and Collaborators
Steward St. Elizabeth's Medical Center of Boston, Inc.
Investigators
Principal Investigator: Andrew Sternlicht, MD St. Elizabeth's Medical Center of Boston
  More Information

No publications provided

Responsible Party: Steward St. Elizabeth's Medical Center of Boston, Inc.
ClinicalTrials.gov Identifier: NCT01303003     History of Changes
Other Study ID Numbers: TAP-00560
Study First Received: February 23, 2011
Last Updated: June 7, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 15, 2014