Intrathecal Morphine for Postoperative Pain

Overseen By Richa Dhawan, MD MPH

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Northwestern University

Must not be taking: Oral steroids, Opioids

Disqualifiers: Severe pulmonary disease, Renal failure, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Immediate postoperative period (up to 48 hours)

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks the best way to manage pain after lung surgery using video-assisted or robotic techniques. Researchers are testing whether a small dose of morphine, given directly to the spine, can reduce the need for other pain medications and increase patient comfort. Participants will receive either the morphine treatment or a placebo (a harmless saltwater solution). The trial seeks participants undergoing elective lung surgery who will not require breathing support afterward. Individuals with severe liver or lung issues, chronic pain, or allergies to morphine are not suitable for this study. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand its benefits for more patients.

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 is the safety track record for Morphine Sulfate?

Research has shown that intrathecal morphine, injected around the spinal cord, is generally safe and effective for post-surgical pain relief. It works well for specific types of pain that respond to opioid medications. Studies have found that it can reduce the need for other painkillers and lessen pain both at rest and during movement shortly after surgery.

The FDA has approved this treatment for managing both short-term and long-term pain when other options aren't enough. While usually safe, like any medication, it can have side effects. However, the chance of technical issues with this method remains low. Overall, intrathecal morphine offers a cost-effective way to manage pain after surgery with a good safety record. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Intrathecal morphine is unique because it delivers pain relief directly into the spinal fluid, offering potentially faster and more effective pain control after surgery. This method stands out from standard pain management options, like oral or intravenous administration, which may take longer to act and can have more systemic side effects. Researchers are excited about this delivery method because it could lead to improved patient comfort and quicker recovery times, making postoperative pain management more efficient and targeted.

What is the effectiveness track record for intrathecal morphine in managing postoperative pain?

Research has shown that intrathecal morphine, which participants in this trial may receive, effectively manages post-surgical pain. Studies have found that it significantly reduces pain within the first 24 hours after an operation and decreases the need for other pain medications during recovery. This treatment has proven effective for various surgeries, including spinal procedures. Overall, intrathecal morphine provides strong pain relief, making it a reliable option for patients with acute post-surgical pain. ^{2 3 4 5 6}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Morphine Active Control 2 Interventions

Intrathecal morphine

Group II: Placebo Placebo Group 2 Interventions

Placebo, Intrathecal saline

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

Approved in United States as Morphine Sulfate for:

• Pain management
• Acute pain
• Chronic pain
• Cancer pain

Approved in European Union as Morphine Sulfate for:

• Severe pain
• Acute pain
• Chronic pain
• Cancer pain

Approved in Canada as Morphine Sulfate for:

• Pain management
• Acute pain
• Chronic pain
• Cancer pain

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intrathecal morphine for postoperative analgesia in patients with idiopathic scoliosis undergoing posterior spinal fusion. Tripi, PA., Poe-Kochert, C., Potzman, J., et al.[2013]

A patient with severe neuralgia experienced respiratory depression after taking a single 20 mg dose of controlled release morphine sulfate (MS Contin), highlighting a potential safety concern with this medication.

The immediate reversal of respiratory depression was achieved with nalorphine chloride, demonstrating the effectiveness of this intervention in managing opioid-related side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Respiratory depression following controlled-release morphine sulfate tablets]. Hoogslag, PA., van Dijk, B., Vinks, AA.[2013]

Intrathecal morphine is effective for postoperative pain control but is associated with high rates of side effects, including nausea (21.5%), vomiting (14.8%), and pruritus (59.5%) in a study of 1,306 patients.

The incidence and severity of these side effects are significantly correlated with factors such as female gender, cesarean section, and higher doses of morphine (over 0.2 mg), indicating a need for careful dosing and consideration of alternatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nausea, vomiting and pruritus induced by intrathecal morphine. Chinachoti, T., Nilrat, P., Samarnpiboonphol, P.[2013]

In a study of 80 women undergoing gynecological surgery, intrathecal morphine provided significantly better pain control on postoperative days 1 and 3 compared to intravenous morphine, particularly in patients who had laparoscopic hysterectomy.

While intrathecal morphine was associated with lower pain scores and shorter hospital stays, it also resulted in a higher incidence of pruritus, indicating a need to balance pain management benefits with potential side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced recovery after gynecological surgery: comparison between intrathecal and intravenous morphine multimodal analgesia. DI Filippo, A., Capezzuoli, T., Fambrini, M., et al.[2023]

In a study of 32 patients who underwent off-pump coronary artery bypass (OPCAB), those who received 5 mcg/kg of intrathecal morphine reported significantly lower pain levels compared to those who did not receive the medication, as measured by the Wong-Baker Visual Analog Scale.

The use of intrathecal morphine was found to be effective and safe, with no significant complications reported, making it a viable option for pain management in the immediate postoperative period for OPCAB patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intrathecal morphine for off-pump coronary artery bypass patients. Jara, FM., Klush, J., Kilaru, V.[2013]

In a study involving 10 primiparous patients, intrathecal morphine sulfate provided effective pain relief during the first stage of labor without compromising the bearing down reflex, indicating its efficacy as an analgesic.

The use of intrathecal morphine was associated with minimal side effects, primarily mild peri-oral itching in some patients, and no adverse effects were observed in the infants, suggesting a safe alternative to epidural anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-dose intrathecal morphine sulphate as sole analgesic for pain of labour in combination with elective forceps delivery. A report of 10 cases. Kadieva, VS., Boezaart, AP.[2014]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 involving 10 patients over 6 days, MS Contin (morphine sulfate in a wax cellulose matrix) demonstrated comparable analgesic efficacy to continuous intravenous morphine for treating burn pain.

MS Contin's oral dosing and extended duration of action make it a promising option for managing burn pain, similar to traditional intravenous morphine infusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of morphine sulfate (MS Contin) in patients with burns: a pilot study. Alexander, L., Wolman, R., Blache, C., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 26 cancer patients with uncontrolled pain, the investigational morphine sulfate Contin (MSC) provided effective pain relief, with all 18 patients who completed the study achieving satisfactory analgesia, especially at extended dosing intervals of q8h and q12h.

MSC allowed for prolonged blood levels of morphine without significant side effects like nausea or respiratory difficulty, and it did not lead to significant drug tolerance over a mean follow-up of four weeks, enhancing the quality of life for patients by reducing the need for frequent dosing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of cancer pain with oral controlled-release morphine sulfate. Meed, SD., Kleinman, PM., Kantor, TG., et al.[2019]

In a study involving eleven patients, epidural injections of 2 to 4 mg morphine sulfate provided excellent pain relief for various types of severe pain, including ischaemic, traumatic, and post-operative pain.

The technique was effective in ten out of eleven patients and was used safely for pain management over a duration of up to five days without significant side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidural analgesia with morphine a preliminary communcation. Torda, TA.[2019]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK526115/

Morphine - StatPearls - NCBI Bookshelf - NIH Morphine is FDA-approved for the management of both acute and chronic pain when alternative therapies are insufficient. Injectable morphine is ...

2. wjgnet.com wjgnet.com/2218-6182/full/v3/i3/191.htm

Intrathecal morphine for postoperative analgesia IT morphine has shown to be effective in patients undergoing spinal surgeries. Ziegeler et al[24] demonstrated the efficacy of 0.4 mg of IT morphine in ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0007091222002860

Current approaches to acute postoperative pain ... In summary, evidence suggests intrathecal morphine has an opioid-sparing effect, and reduces early (<24 h) rest and dynamic pain (<48 h) with similar incidence ...

4. bmcanesthesiol.biomedcentral.com bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-020-01113-8

Intrathecal morphine is associated with reduction in ... Postoperative pain scores up to 24 h post-surgery were significantly reduced in the ITM group. There was no statistically significant difference ...

5. mdanderson.org mdanderson.org/documents/for-physicians/algorithms/clinical-management/clin-management-post-op-pain-web-algorithm.pdf

Peri-Operative Pain Management Codeine, morphine, hydromorphone, and oxycodone should be used with caution in patients with decreased renal function. ○ Opioids NOT recommended for cancer ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK499880/

Intrathecal Morphine - StatPearls - NCBI Bookshelf - NIH Intrathecal morphine is more likely to benefit patients with nociceptive or neuropathic pain that is well localized and responsive to systemic opioids.