Morphine for Pain, Postoperative

Phase-Based Estimates
2
Effectiveness
3
Safety
Saint Louis University, Saint Louis, MO
Pain, Postoperative+6 More
Morphine - Drug
Eligibility
18+
All Sexes
Eligible conditions
Pain, Postoperative

Study Summary

This study is evaluating whether a pain medication called Toradol may help improve pain management for individuals who have had a femur (thigh bone) surgically implanted.

See full description

Eligible Conditions

  • Pain, Postoperative
  • Neoplasm Metastasis
  • Pain
  • Multiple Myeloma
  • Lymphoma
  • Bone Metastases
  • Opioids Use

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether Morphine will improve 1 primary outcome and 3 secondary outcomes in patients with Pain, Postoperative. Measurement will happen over the course of Up to six weeks post-op.

Post-op days 1-14
Milligram Morphine Equivalent (MME) of Opioid Medications Utilized
Up to six weeks post-op
Numerical Rating Scale (NRS)
Patient Reported Outcomes Measurement System (PROMIS) Pain Intensity Scale
Single Assessment Numerical Evaluation (SANE)

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Control
Experimental Arm
Placebo group

This trial requires 60 total participants across 2 different treatment groups

This trial involves 2 different treatments. Morphine is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Experimental ArmFor the first 24 hours following surgery, patients younger than 65 years old will be administered a maximum of 120 mg/day bolus IV ketorolac (30 mg every 6 hours). Patients older than 65 years old or with history of advanced renal impairment will receive a maximum of 60 mg/day bolus IV ketorolac (15 mg every 6 hours). All patients may also be given acetaminophen 500 mg PO Q4 hours PRN for mild pain, oxycodone-acetaminophen 5-325 mg PO Q4 hours PRN for moderate- severe pain, and morphine IV PRN (or other opioid) for severe breakthrough pain while hospitalized. At discharge, they will be prescribed 1-2 hydrocodone-acetaminophen 5-325 mg Q4 hours, quantity 50. Those with preexisting liver disease will be prescribed the equivalent in oxycodone and will not receive acetaminophen for mild pain.
ControlFollowing surgery, patients will be given acetaminophen 500 mg PO Q4 hours PRN for mild pain, oxycodone-acetaminophen 5-325 mg PO Q4 hours PRN for moderate-severe pain, and morphine IV PRN (or other opioid) for severe breakthrough pain while hospitalized. They will also be given a placebo injection of normal saline every 6 hours for the first 24 hours following surgery. At discharge, patients will be prescribed 1-2 hydrocodone-acetaminophen 5-325 mg Q4 hours PRN quantity 50, unless they have preexisting liver disease, in which case they will be prescribed the equivalent in oxycodone. They will not receive a nerve block.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxycodone
FDA approved
Morphine
FDA approved
Ketorolac
FDA approved
Acetaminophen
FDA approved
Oxycodone
FDA approved
Hydrocodone
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to six weeks post-op
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to six weeks post-op for reporting.

Who is running the study

Principal Investigator
D. G. A. s.
Prof. David Greenberg;; Associate ssor, MD
St. Louis University

Closest Location

Saint Louis University - Saint Louis, MO

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Femoral Shaft or Neck bone lesion
18 years old or greater
Plan to undergo prophylactic intramedullary nailing of one or both femurs

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get pain, postoperative a year in the United States?

Add answer

Of the US adult population the percentage of those who experienced postoperative pain the previous year was 17.1%. When analyzed in terms of the overall percentage in the United States, 15.7% of Americans have reported having moderate or severe pain in the past 24 hours.

Unverified Answer

Can pain, postoperative be cured?

Add answer

Pain, postoperative is a very debilitating condition which can be very difficult to treat. There are a number of factors that may be responsible for the occurrence of pain in the first place. Some have suggested that pain in one of the extremities is a direct result of nerves that are damaged after neurosurgery. To find what is causing the pain you can [power(https://www.withpower.com/clinical-trials/surgeries-and-injury-rewards)) or [power(https://www.nhs.co.

Unverified Answer

What causes pain, postoperative?

Add answer

Although most patients can have surgery with minimal pain, pain is a problem in 4% to 20% of patients. The underlying mechanism remains unknown; however, it is evident that there are some patients who can be predicted to have pain, and then have a better outcome from surgery. The quality of the surgeon will affect the length of pain after surgery.

Unverified Answer

What are common treatments for pain, postoperative?

Add answer

Recent findings of this study show the existence of more than one treatment modality for pain, postoperative: there is not only one ideal treatment. For this reason, we would recommend the use of more than one modality in patients with chronic pain or postoperative pain; we would suggest the use of the opioid sparing modality as this could reduce side effect, reduce the dose, lessen the risk of abuse and misuse.

Unverified Answer

What are the signs of pain, postoperative?

Add answer

The pain of the surgical intervention may be evident at postoperative day 1, with an increase in the intensity of pain which can persist for up to 7 days postoperatively.\n

Unverified Answer

What is pain, postoperative?

Add answer

Although a majority of patients reported being free of pain at discharge, many reported some pain. There was not a difference between men and women in frequency of pain at discharge. Younger age was associated with increased frequency of pain at discharge. Pain was not a common symptom, and thus does not need to be a routine part of an evaluation.

Unverified Answer

What is the survival rate for pain, postoperative?

Add answer

In most patients, pain persisted. In some patients, the pain was relieved within 3 months post operation. Survival depended on the severity of pain in the last week of the illness.

Unverified Answer

How quickly does pain, postoperative spread?

Add answer

The postoperative period of pain spreads quickly from peripheral parts of the extremities to the central nervous system. Postoperative pain is also associated with morphine consumption in patients undergoing total hip and knee arthroplasty. This association was not observed for patients undergoing ambulatory total hip arthroplasty. Further studies are warranted to define the magnitude and distribution of postoperative pain.

Unverified Answer

How does morphine work?

Add answer

Although low-dose morphine given in small, single-site studies for postoperative analgesia may produce a transient analgesic effect after surgery, these studies lacked the large, well-controlled study size and duration essential to evaluate this issue. In a recent study, findings, morphine did not provide longer-term, significant improvements in postoperative [pain management](https://www.withpower.com/clinical-trials/pain-management) compared with placebo, although it resulted in faster postoperative recovery. Morphine provided no improvement in hospital stay, discharge disposition, or pain control in this patient population.

Unverified Answer

How serious can pain, postoperative be?

Add answer

We did find an overall mean score for pain of 3.7 (ranging from 2.7 to 5.0), a range that is consistent with the mean pain scores from other sources, such as that provided by the EuroSCORE which ranges from 2-8 (mean = 3.6). Pain scores appear to worsen to a range from 2.4 through 5.0 when compared to the reported scores of most postoperative patients. There was some evidence that worse pain scores were associated with higher EuroSCORE scores in this sample. No statistically significant differences were found within the different subgroups, confirming the variability of postoperative pain.

Unverified Answer

What are the latest developments in morphine for therapeutic use?

Add answer

The use of morphine for pain relief and its side effects are still frequently encountered in the present guidelines. However, the results of recent investigations indicated that a wide variety of morphine formulations, including methadone and dihydrocodeine, can be helpful in relieving postoperative pain. The use of opioid-antagonists can be helpful in reducing the use of morphine.

Unverified Answer

Does pain, postoperative run in families?

Add answer

This family study of individuals and families with the genetic disease familial dysautonomia revealed no evidence for significant pain reporting by any individual and no evidence for significant pain reporting by any individual who had a genetic relative with the disease. Data from a recent study add to considerable evidence that pain is likely not an important gene, or polymorphism, for familial dysautonomia.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Pain, Postoperative by sharing your contact details with the study coordinator.