Postoperative Pain Control for Prostatectomy

NCT ID: NCT00913068

Last Updated: 2021-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2011-09-30

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.

Detailed Description

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). As the amount of opiates used can be significant, we have to be aware of their inherent risks. Opiates have an excellent pain control profile, working peripherally by decreasing the amount of neurotransmitters released from neurons involving noxious stimuli, and also in their central processing. 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.

Thus we propose the use of a relatively new regional anesthetic technique be employed to further decrease the need for opiates in our prostatectomy patients' post-op course, while adequately controlling their pain.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

TAP arm

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

Group Type: EXPERIMENTAL

Transverse Abdominal Plan (TAP)

Intervention Type: PROCEDURE

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

standard post operative pain control

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.

Group Type: ACTIVE_COMPARATOR

standard post op pain control

Intervention Type: PROCEDURE

opiates

Interventions

Transverse Abdominal Plan (TAP)

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

Intervention Type: PROCEDURE

standard post op pain control

opiates

Intervention Type: PROCEDURE

Other Intervention Names

lidocaine; ropivacaine; timed assessments for pain and medications

Eligibility Criteria

Inclusion Criteria

• prostate cancer for radical prostatectomy

Exclusion Criteria

• chronic pain or opiate use

• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Nova Scotia Health Authority

OTHER

Sponsor Role: lead

Responsible Party

Ricardo Rendon

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ricardo A Rendon, MD

Role: PRINCIPAL_INVESTIGATOR

Queen Elizabeth Health Sciences Centre

Locations

Queen Elizabeth Health Sciences Centre

Halifax, Nova Scotia, Canada

Countries

Canada

Other Identifiers

version 2 July 13, 2009

Identifier Type: -

Identifier Source: org_study_id