Postoperative PainNCT01984463
Impact of Epidural Morphine on Shoulder Pain Following Thoracotomy.
A study testing Fentanyl and Morphine in people with Postoperative Pain and Shoulder Pain, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain, Shoulder Pain
- What is being tested?
- Fentanyl and Morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2014to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 75 years
- Scheduled for an elective thoracotomy
- Physical status 1-3
Who cannot join
- 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.
Show all 9Show fewer
- The inability to understand a verbal numerical pain scale (VNPS) despite previous instruction
- Severe renal insufficiency
- Patient refusal
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2L 4M1
About this study
Official title: Impact of Epidural Morphine on the Incidence and Severity of Shoulder Pain Following Thoracotomy.
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.
Read the 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.
- Conditions
- Postoperative Pain, Shoulder Pain
- Keywords
- Postoperative pain, Shoulder pain, Thoracotomy
- Medical subject headings
- Pain, Postoperative, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
Also called Epidural 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.
MorphineDrug
Also called Epidural 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of pain using a Verbal Numeric Pain Scale (VNPS)
Measured: 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
Measured: 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
Measured: 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
Measured: 24 hours after surgery.
Signs of neuropathic pain using the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) scale
Measured: 24 hours after surgery.
Impact of epidural morphine on gas exchange by measuring arterial blood gases
Measured: Every 8 hours for the first 24 hours following surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study startFeb 2014
- Primary completionMay 2014
- Study completionMay 2014
Why it stopped: Increased incidence of respiratory depression in the morphine group
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Girard, MD, FRCPC, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01984463
- Sponsor's protocol ID
- 13.203
- Status last verified
- May 2014
- First submitted
- 4 Nov 2013
- Last updated
- 12 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Epidural Morphine on the Incidence and Severity of Shoulder Pain Following Thoracotomy.
- ClinicalTrials.gov ID
- NCT01984463
- Acronym / sponsor ID
- 13.203
- Conditions
- Postoperative Pain, Shoulder Pain
- Keywords
- Postoperative pain, Shoulder pain, Thoracotomy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Increased incidence of respiratory depression in the morphine group
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- Feb 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 14 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fentanyl | Active comparator | Drug: FentanylPatients 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. |
| Morphine | Experimental | Drug: MorphinePatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18 to 75 years
- Scheduled for an elective thoracotomy
- Physical status 1-3
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FentanylAlso: Epidural fentanylPatients 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. | Drug | Fentanyl |
| MorphineAlso: Epidural morphinePatients 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. | Drug | Morphine |
Primary outcome
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.
5 secondary outcomes
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.
Results and safety
The study was stopped early (reason given: Increased incidence of respiratory depression in the morphine group). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François Girard, MD, FRCPC principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fentanyl and Morphine in people with Postoperative Pain and Shoulder Pain, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Increased incidence of respiratory depression in the morphine group). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2014.