Impact of Epidural Morphine on Shoulder Pain Following Thoracotomy.
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|ClinicalTrials.gov Identifier: NCT01984463|
Recruitment Status : Terminated (Increased incidence of respiratory depression in the morphine group)
First Posted : November 14, 2013
Last Update Posted : May 12, 2014
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 or disease||Intervention/treatment||Phase|
|Postoperative Pain Shoulder Pain||Drug: Fentanyl Drug: Morphine||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Impact of Epidural Morphine on the Incidence and Severity of Shoulder Pain Following Thoracotomy.|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
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.
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
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.
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
- 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. ]
- Opioid consumption [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 24 hours after surgery. ]
- Signs of neuropathic pain using the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) scale [ Time Frame: 24 hours after surgery. ]
- Impact of epidural morphine on gas exchange by measuring arterial blood gases [ Time Frame: Every 8 hours for the first 24 hours following surgery. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01984463
|Centre Hospitalier de l'Université de Montréal (CHUM)|
|Montreal, Quebec, Canada, H2L 4M1|
|Principal Investigator:||François Girard, MD, FRCPC||Centre hospitalier de l'Université de Montréal (CHUM)|