Impact of Epidural Morphine on Shoulder Pain Following Thoracotomy.

NCT01984463 | Terminated

• 1 other identifier: 13.203
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain; Shoulder Pain

Keywords

Postoperative pain; Shoulder pain; Thoracotomy

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (5)

• Opioid consumption

  From arrival in the recovery room until 4 days after surgery or discharge from the hospital, the first to occur.

• Side-effects attributable to analgesia

  From surgery until 4 days after surgery or discharge from the hospital, the first to occur.

• Interference of pain with daily activities using the Brief Pain Inventory

  24 hours after surgery.

• Signs of neuropathic pain using the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) scale

  24 hours after surgery.

• Impact of epidural morphine on gas exchange by measuring arterial blood gases

  Every 8 hours for the first 24 hours following surgery.

Study Arms (2)

Fentanyl

ACTIVE COMPARATOR

Patients will be randomized to receive by the epidural catheter a bolus dose of 100 mcg of fentanyl followed by an infusion of epidural bupivacaine 0.1% and fentanyl 2 mcg/mL.

Drug: Fentanyl

Morphine

EXPERIMENTAL

Patients will be randomized to receive by the epidural catheter a bolus dose of 3 mg of morphine followed by an infusion of epidural bupivacaine 0.1% and morphine 50 mcg/mL.

Drug: Morphine

Interventions

Fentanyl DRUG

Patients will receive an epidural bolus dose of 100 mcg of fentanyl followed by an infusion of epidural bupivacaine 0.1% and fentanyl 2 mcg/mL continued postoperatively until the surgical drains are removed or for a maximum of five days.

Also known as: Epidural fentanyl

Fentanyl

Morphine DRUG

Patients will receive an epidural bolus dose of 3 mg of morphine followed by an infusion of epidural bupivacaine 0.1% and morphine 50 mcg/mL continued postoperatively until the surgical drains are removed or for a maximum of five days.

Also known as: Epidural morphine

Morphine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 to 75 years
• Scheduled for an elective thoracotomy
• Physical status 1-3

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2L 4M1, Canada

Location

MeSH Terms

Conditions

Pain, Postoperative; Shoulder Pain

Interventions

Fentanyl; Morphine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Arthralgia; Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• François Girard, MD, FRCPC

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: November 14, 2013
• Study Start: February 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 12, 2014

Record last verified: 2014-05

Locations

CA (1)