Evaluation of Addition of Dexamethasone to Transversus Abdominis Plane (TAP) Peripheral Nerve Block
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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? |
- 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.
- 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 |
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| United States, Massachusetts | |
| St. Elizabeth's Medical Center of Boston | |
| Boston, Massachusetts, United States, 02135 | |
| 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:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases 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 May 23, 2013