Postoperative Pain Control for Prostatectomy

NCT00913068 | Completed Results

• 1 other identifier: version 2 July 13, 2009
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The researchers propose to investigate a relatively new anesthetic procedure, in order to maximize patient comfort and minimize the use of narcotics after a radical prostatectomy.

Conditions

Prostate Cancer

Keywords

radical prostatectomy

Outcome Measures

Primary Outcomes (1)

• Total Milligrams of Opiates

  mean number of milligrams used postoperatively

  2, 6,12, 24, 48 and 72 hours

Study Arms (2)

TAP arm

EXPERIMENTAL

in the experimental arm, the procedure will consist of the staff urologist injecting local anesthetic into the anterior abdominal wall bilaterally from the inside of the abdomen at the end of their surgery

Procedure: Transverse Abdominal Plan (TAP)

standard post operative pain control

ACTIVE COMPARATOR

Our current post operative analgesic strategy involves a multi-modal approach, using local injectable anesthetic around the incision and systemic medications (i.e. non-steroidal anti-inflammatories, acetaminophen and break-through doses of opiates). Some of the more common adverse reactions are reparatory depression, sedation, confusion, delirium, nausea, pruritis, constipation, hypotension and bradycardia. Often it is these resulting side effects that extend the length of in hospital rehabilitation, and decrease a patient's overall satisfaction.

Procedure: standard post op pain control

Interventions

Transverse Abdominal Plan (TAP) PROCEDURE

An injectable anesthetic is introduced to a specific anatomic area where the sensory neurons supplying the operative field.

Also known as: lidocaine, ropivacaine

TAP arm

standard post op pain control PROCEDURE

opiates

Also known as: timed assessments for pain and medications

standard post operative pain control

Eligibility Criteria

• Age: Up to 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• prostate cancer for radical prostatectomy

You may not qualify if:

• chronic pain or opiate use

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Queen Elizabeth Health Sciences Centre

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Lidocaine; Ropivacaine; Dosage Forms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Results Point of Contact

• Title: Dr. Ricardo A. Rendon
• Organization: Capital District Health Authority

rrendon@dal.ca

9024736604

Study Officials

• Ricardo A Rendon, MD

  Queen Elizabeth Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: June 1, 2009
• First Posted: June 3, 2009
• Study Start: July 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 4, 2021
• Results First Posted: October 4, 2021

Record last verified: 2021-09

Locations

CA (1)