Postoperative Pain Clinical Trial
Official title:
Impact of Epidural Morphine on the Incidence and Severity of Shoulder Pain Following Thoracotomy.
This study is designed to assess the impact of epidural morphine on:
- The incidence and severity of shoulder pain following a thoracotomy.
- The need for additional analgesics, such as opioids for the relief of shoulder pain.
- Its safety profile compared to epidural fentanyl following a thoracotomy.
The basic hypothesis of this study is that an infusion of epidural bupivacaine and morphine
initiated after the induction of anesthesia and continued until 72 hours postoperatively
will reduce the incidence and severity of shoulder pain following a thoracotomy when
compared to an epidural infusion of bupivacaine and fentanyl.
Status | Terminated |
Enrollment | 22 |
Est. completion date | May 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Patients aged 18 to 75 years - Scheduled for an elective thoracotomy - Physical status 1-3 Exclusion Criteria: - Contraindication to epidural analgesia (coagulopathy, sepsis or local infection at the site of injection, spinal deformity, previous major spinal thoracic surgery) - A known allergy to local anesthetics, acetaminophen, fentanyl or morphine. - Pre-existing shoulder pain ipsilateral to the surgery - Pre-existing chronic pain - Current use of opioids - Recent history of alcohol or drug abuse. - The inability to understand a verbal numerical pain scale (VNPS) despite previous instruction - Severe renal insufficiency - Patient refusal |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Centre Hospitalier de l'Université de Montréal (CHUM) | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Centre hospitalier de l'Université de Montréal (CHUM) |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intensity of pain using a Verbal Numeric Pain Scale (VNPS) | From arrival in the recovery room until 4 days after surgery or discharge from the hospital, the first to occur. | Yes | |
Secondary | Opioid consumption | From arrival in the recovery room until 4 days after surgery or discharge from the hospital, the first to occur. | Yes | |
Secondary | Side-effects attributable to analgesia | From surgery until 4 days after surgery or discharge from the hospital, the first to occur. | Yes | |
Secondary | Interference of pain with daily activities using the Brief Pain Inventory | 24 hours after surgery. | Yes | |
Secondary | Signs of neuropathic pain using the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) scale | 24 hours after surgery. | Yes | |
Secondary | Impact of epidural morphine on gas exchange by measuring arterial blood gases | Every 8 hours for the first 24 hours following surgery. | Yes |
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