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

NCT01303003 | Completed Results

• 1 other identifier: TAP-00560
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate CA

Outcome Measures

Primary Outcomes (1)

• Time to First Request of Additional Analgesia

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

  24 hours post-op

Secondary Outcomes (1)

• 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

Study Arms (2)

Treatment Arm 1

EXPERIMENTAL

Bilateral TAP block consisting of 40cc. 0.125% bupivicaine + 0.5cc. dexamethasone (2mg.) per side.

Drug: Dexamethasone

Treatment Arm 2

ACTIVE COMPARATOR

Bilateral TAP block of 40cc. of 0.125% bupivicaine + 0.5cc. sterile saline per side

Procedure: TAP block

Interventions

Dexamethasone DRUG

40 cc. 0.125% bupivicaine + 0.5cc. dexamethasone (2mg.) per side.

Treatment Arm 1

TAP block PROCEDURE

Bilateral TAP block of 40cc. of 0.125% bupivicaine + 0.5cc. sterile saline per side

Treatment Arm 2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Steward St. Elizabeth's Medical Center of Boston, Inc.: lead

Study Sites (1)

St. Elizabeth's Medical Center of Boston

Boston, Massachusetts, 02135, United States

Location

MeSH Terms

Interventions

Dexamethasone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Meghan Cashman, IRB Manager
• Organization: Steward St. Elizabeth's Medical Center

meghan.cashman@steward.org

617-789-2804

Study Officials

• Andrew Sternlicht, MD

  St. Elizabeth's Medical Center of Boston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2011
• First Posted: February 24, 2011
• Study Start: December 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: September 21, 2018
• Results First Posted: September 21, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)