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Impact of Epidural Morphine on Shoulder Pain Following Thoracotomy.

Primary Purpose

Postoperative Pain, Shoulder Pain

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Fentanyl
Morphine
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Postoperative pain, Shoulder pain, Thoracotomy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier de l'Université de Montréal (CHUM)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Fentanyl

Morphine

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Intensity of pain using a Verbal Numeric Pain Scale (VNPS)

Secondary Outcome Measures

Opioid consumption
Side-effects attributable to analgesia
Interference of pain with daily activities using the Brief Pain Inventory
Signs of neuropathic pain using the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) scale
Impact of epidural morphine on gas exchange by measuring arterial blood gases

Full Information

First Posted
November 4, 2013
Last Updated
May 9, 2014
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
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1. Study Identification

Unique Protocol Identification Number
NCT01984463
Brief Title
Impact of Epidural Morphine on Shoulder Pain Following Thoracotomy.
Official Title
Impact of Epidural Morphine on the Incidence and Severity of Shoulder Pain Following Thoracotomy.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Terminated
Why Stopped
Increased incidence of respiratory depression in the morphine group
Study Start Date
February 2014 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Despite adequate epidural analgesia, up to 97% of patients undergoing thoracotomy will experience ipsilateral shoulder pain. Although this pain is well recognized, its cause remains unclear. Several mechanisms have been suggested to explain this pain, including somatic and visceral as well as phrenic nerve nociception. The phrenic nerve arises from the third to the fifth cervical nerves and provides the sensory innervation for the mediastinal and diaphragmatic pleura and pericardium. Patients will complain of a constant, moderate to severe aching pain, in the posterior deltoid and in the suprascapular region, ipsilateral to the surgery. Different treatments have been used to alleviate post-thoracotomy shoulder pain, but few of these efforts have been proven effective and safe. A mixture of epidural bupivacaine and fentanyl is considered the standard of care for post-thoracotomy analgesia in our center. The infusion is started after induction of anesthesia with a bolus dose followed with a continuous infusion and bolus doses as needed for the following days. To optimize the use of epidural analgesia after thoracotomy, it would seem well-advised to try to reach higher dermatomes. This could possibly be achieved by using a different opioid in combination with bupivacaine in the epidural infusion. Morphine could be an interesting agent in order to reach cervical spinous dermatomes probably involved in the genesis of post-thoracotomy shoulder pain. Methods: The anesthetic technique and monitoring will be standardized. Prior to the induction of general anesthesia, a thoracic epidural catheter will be inserted under local anesthesia between the fourth and the eight spinous processes. Correct placement of the epidural will be assessed. A bolus dose of fentanyl 100 mcg or morphine 3 mg will be given by the epidural catheter as per randomization. The epidural infusion will be initiated at a rate of 0.1 mL/kg/hr before surgery and continued postoperatively until the surgical drains are removed or for a maximum of five days. To relieve thoracic pain, the epidural infusion rate will be adjusted up to a maximum of 12 mL/hr, with boluses of 0.05 mL/kg as needed. Hydromorphone will be used postoperatively as rescue analgesia for shoulder pain. All patients will receive standardised doses of acetaminophen for the first 48 hours following surgery. On arrival in the recovery room, correct placement of the epidural will be reassessed. During the immediate postoperative period, the intensity of pain will be assessed using a Verbal Numeric Pain Scale (0-10). Pain will be assessed at 2,4,8,12 and 24 hours after surgery and daily thereafter, for a total duration of 4 postoperative days. Interference of pain with daily activities will be assessed using the Brief Pain Inventory (BPI) at 24 hours following surgery. Signs of neuropathic pain will be assessed using the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) scale at 24 hours following surgery. Side-effects attributable to analgesia will be recorded. Arterial blood samples will be collected every 8 hours for the first 24 hours postoperatively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Shoulder Pain
Keywords
Postoperative pain, Shoulder pain, Thoracotomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fentanyl
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Morphine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Other Intervention Name(s)
Epidural fentanyl
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Morphine
Other Intervention Name(s)
Epidural morphine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intensity of pain using a Verbal Numeric Pain Scale (VNPS)
Time Frame
From arrival in the recovery room until 4 days after surgery or discharge from the hospital, the first to occur.
Secondary Outcome Measure Information:
Title
Opioid consumption
Time Frame
From arrival in the recovery room until 4 days after surgery or discharge from the hospital, the first to occur.
Title
Side-effects attributable to analgesia
Time Frame
From surgery until 4 days after surgery or discharge from the hospital, the first to occur.
Title
Interference of pain with daily activities using the Brief Pain Inventory
Time Frame
24 hours after surgery.
Title
Signs of neuropathic pain using the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) scale
Time Frame
24 hours after surgery.
Title
Impact of epidural morphine on gas exchange by measuring arterial blood gases
Time Frame
Every 8 hours for the first 24 hours following surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Girard, MD, FRCPC
Organizational Affiliation
Centre hospitalier de l'Université de Montréal (CHUM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier de l'Université de Montréal (CHUM)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada

12. IPD Sharing Statement

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Impact of Epidural Morphine on Shoulder Pain Following Thoracotomy.

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