90 Participants Needed

Intrathecal Morphine for Postoperative Pain

RD
Overseen ByRicha Dhawan, MD MPH
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using certain medications like oral steroids or have conditions like chronic pain, you may not be eligible to participate.

What data supports the effectiveness of the drug for postoperative pain relief?

Research shows that intrathecal morphine significantly reduces pain scores and the need for additional pain medication after lumbar spine surgery. It also provides better pain relief compared to other methods without increasing side effects, and it can shorten hospital stays.12345

Is intrathecal morphine safe for humans?

Intrathecal morphine has been used safely in humans, with mild side effects like itching reported in some cases. However, morphine can cause serious side effects like respiratory depression (slowed breathing) in some situations, so it should be used with caution.56789

How is the drug Morphine Sulfate used in intrathecal administration unique for postoperative pain management?

Intrathecal Morphine Sulfate is unique because it is administered directly into the spinal fluid, providing targeted pain relief with potentially lower doses compared to other methods, which can reduce the need for additional pain medication. This method can be particularly effective for managing postoperative pain, as it has been shown to significantly reduce pain scores and the requirement for extra analgesics.1371011

What is the purpose of this trial?

VATS is widely used for diagnosis and treatment of intrathoracic conditions. Despite many benefits, postoperative pain continues to be intense after VATS. The optimal strategy for pain management has not been defined. In this randomized, placebo-controlled, double-blinded clinical investigation, investigators hypothesize that 5 mcg/kg intrathecal morphine will decrease postoperative analgesic consumption and reduce pain.

Eligibility Criteria

This trial is for adults aged 18-80 undergoing elective lung surgery (VATS) with expected immediate recovery from anesthesia. Candidates must understand English and not have severe health issues like advanced organ diseases, drug or alcohol abuse, chronic pain conditions, or be on life support treatments.

Inclusion Criteria

I will be put to sleep during surgery and wake up afterwards.
I will be put to sleep during surgery and expected to breathe on my own afterwards.
I am scheduled for a minimally invasive lung surgery.

Exclusion Criteria

Your blood does not clot normally before surgery.
I have a bleeding disorder.
I am on a breathing machine before surgery.
See 13 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either intrathecal morphine or placebo during surgery

Immediate postoperative period (up to 48 hours)
In-hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including phone surveys at 1 and 3 months post-surgery

3 months
Phone surveys at 1 and 3 months

Treatment Details

Interventions

  • Morphine Sulfate
  • Placebo
Trial Overview The study tests if a single dose of intrathecal morphine (5 mcg/kg) can better manage post-surgery pain compared to a placebo in patients after VATS. It's randomized and double-blinded, meaning neither the doctors nor the patients know who gets the real medicine versus the placebo.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: MorphineActive Control2 Interventions
Intrathecal morphine
Group II: PlaceboPlacebo Group2 Interventions
Placebo, Intrathecal saline

Morphine Sulfate is already approved in United States, European Union, Canada for the following indications:

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Approved in United States as Morphine Sulfate for:
  • Pain management
  • Acute pain
  • Chronic pain
  • Cancer pain
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Approved in European Union as Morphine Sulfate for:
  • Severe pain
  • Acute pain
  • Chronic pain
  • Cancer pain
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Approved in Canada as Morphine Sulfate for:
  • Pain management
  • Acute pain
  • Chronic pain
  • Cancer pain

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials
1,086
Recruited
844,000+

Findings from Research

Intrathecal morphine significantly reduced postoperative pain scores after lumbar spine surgery, indicating its efficacy in pain management (p < 0.01).
The use of intrathecal morphine also decreased the need for additional pain relief medications post-surgery (p < 0.05), although potential side effects warrant caution until more experience is gathered.
Use of intrathecal morphine for postoperative pain relief following lumbar spine surgery.O'Neill, P., Knickenberg, C., Bogahalanda, S., et al.[2022]
In a study of 56 patients undergoing lumbar spinal surgery, intrathecally administered morphine sulfate significantly improved postoperative pain control in a dose-dependent manner compared to placebo, without increasing side effects.
Patients receiving 0.25 or 0.5 mg of intrathecal morphine had reduced narcotic consumption and shorter hospital stays, indicating that this method can enhance postoperative recovery when used safely.
Use of intrathecally administered morphine in the treatment of postoperative pain after lumbar spinal surgery: a prospective, double-blind, placebo-controlled study.Ross, DA., Drasner, K., Weinstein, PR., et al.[2022]
A retrospective study of 407 patients with idiopathic scoliosis showed that a moderate dose of intrathecal morphine (9 to 19 microg/kg) effectively manages postoperative pain with minimal complications.
Higher doses of intrathecal morphine (20 microg/kg or more) did not provide significantly better pain relief and were associated with a higher risk of respiratory depression and increased need for pediatric intensive care unit (PICU) admission.
Intrathecal morphine for postoperative analgesia in patients with idiopathic scoliosis undergoing posterior spinal fusion.Tripi, PA., Poe-Kochert, C., Potzman, J., et al.[2013]

References

Use of intrathecal morphine for postoperative pain relief following lumbar spine surgery. [2022]
Use of intrathecally administered morphine in the treatment of postoperative pain after lumbar spinal surgery: a prospective, double-blind, placebo-controlled study. [2022]
Intrathecal morphine for postoperative analgesia in patients with idiopathic scoliosis undergoing posterior spinal fusion. [2013]
Intrathecal morphine for off-pump coronary artery bypass patients. [2013]
Epidural analgesia with morphine a preliminary communcation. [2019]
[Respiratory depression following controlled-release morphine sulfate tablets]. [2013]
Low-dose intrathecal morphine sulphate as sole analgesic for pain of labour in combination with elective forceps delivery. A report of 10 cases. [2014]
Management of cancer pain with oral controlled-release morphine sulfate. [2019]
Use of morphine sulfate (MS Contin) in patients with burns: a pilot study. [2019]
Nausea, vomiting and pruritus induced by intrathecal morphine. [2013]
Enhanced recovery after gynecological surgery: comparison between intrathecal and intravenous morphine multimodal analgesia. [2023]
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