Impact of Epidural Morphine on Shoulder Pain Following Thoracotomy.

Postoperative Pain Clinical Trial

Official title:

Impact of Epidural Morphine on the Incidence and Severity of Shoulder Pain Following Thoracotomy.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01984463
• Other study ID #: 13.203
• Status: Terminated
• Phase: N/A
• First received: November 4, 2013
• Last updated: May 9, 2014
• Start date: February 2014
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain
• Shoulder Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Université de Montréal (CHUM)	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

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