Postoperative Pain Clinical Trial
Official title:
Continuous Transversus Abdominis Plane (TAP) Block for Open Radical Prostatectomy. A Double Blind Randomized Study.
Verified date | March 2015 |
Source | McGill University Health Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
This is a prospective, double blind, randomized study is proposed in patients undergoing open radical prostatectomy: its objective is to establish whether continuous bilateral TAP blocks would provide adequate perioperative analgesia, decrease opioid consumption, reduce the incidence of opioid-related side effects, and facilitate surgical recovery (in terms of PACU and hospital discharge).
Status | Terminated |
Enrollment | 25 |
Est. completion date | March 2013 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age: 18 years and over - ASA class 1, 2 - Elective open radical prostatectomy Exclusion Criteria: - Any history or signs of cardiac, hepatic and renal failure. Patients with raised serum LFTs and serum creatinine outside normal range - Any chronic use of opioid analgesic - Morbid obesity (BMI>40) - History of allergic reactions to any of the study medications and the medications used for the trial - Pregnancy - Previous abdominal surgery |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | McGill University Health Centre, Montreal General Hospital | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
McGill University Health Center |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postoperative morphine consumption | at 24 hour after surgery | No | |
Secondary | Incidence of nausea and vomiting | at 2, 12, 24 and 48 hour after surgery | No | |
Secondary | VRS for pain at rest, during ambulation and coughing | at 2, 12, 24 and 48 hour after surgery | No | |
Secondary | Assessment of recovery | Assessment of recovery (two-minute walking test, Miles scale) and time out of bed (sitting or walking will be measured every day until hospital discharge. | at 24 hours after the surgery and every 24 hours until patients are discharged. | No |
Secondary | Postoperative morphine consumption | at 2, 12 and 48 hours after surgery | No |
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