Impact of Epidural Morphine on Shoulder Pain Following Thoracotomy.

This study has been terminated.
(Increased incidence of respiratory depression in the morphine group)
Sponsor:
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT01984463
First received: November 4, 2013
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Postoperative Pain
Shoulder Pain
Drug: Fentanyl
Drug: Morphine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Epidural Morphine on the Incidence and Severity of Shoulder Pain Following Thoracotomy.

Resource links provided by NLM:


Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Opioid consumption [ Time Frame: From arrival in the recovery room until 4 days after surgery or discharge from the hospital, the first to occur. ] [ Designated as safety issue: Yes ]
  • Side-effects attributable to analgesia [ Time Frame: From surgery until 4 days after surgery or discharge from the hospital, the first to occur. ] [ Designated as safety issue: Yes ]
  • Interference of pain with daily activities using the Brief Pain Inventory [ Time Frame: 24 hours after surgery. ] [ Designated as safety issue: Yes ]
  • Signs of neuropathic pain using the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) scale [ Time Frame: 24 hours after surgery. ] [ Designated as safety issue: Yes ]
  • Impact of epidural morphine on gas exchange by measuring arterial blood gases [ Time Frame: Every 8 hours for the first 24 hours following surgery. ] [ Designated as safety issue: Yes ]

Enrollment: 22
Study Start Date: February 2014
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fentanyl
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
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.
Other Name: Epidural fentanyl
Experimental: Morphine
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
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.
Other Name: Epidural morphine

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01984463

Locations
Canada, Quebec
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada, H2L 4M1
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
Principal Investigator: François Girard, MD, FRCPC Centre hospitalier de l'Université de Montréal (CHUM)
  More Information

No publications provided

Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT01984463     History of Changes
Other Study ID Numbers: 13.203
Study First Received: November 4, 2013
Last Updated: May 9, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
Postoperative pain
Shoulder pain
Thoracotomy

Additional relevant MeSH terms:
Pain, Postoperative
Shoulder Pain
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Morphine
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on October 02, 2014