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Methadone for Pain Management in Spinal Surgery
Study Summary
This trial is testing whether giving methadone during spinal surgery can help manage pain better than other standard pain medications. Researchers will compare methadone with a placebo to see which one works best.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I expect to stay in the hospital for at least 2 nights after surgery.I am currently taking medication that includes opioid blockers.I cannot take certain pain medications like acetaminophen or opioids.I have had spine surgery on less than 2 levels.My spine condition does not require devices for treatment.My BMI is 36 or higher.I have a documented heart condition with weak heart pumping.I have used methadone in the last 6 weeks.I have had surgery to remove a tumor from within my spinal canal.I have had no surgical complications needing immediate correction within 3 days post-surgery.I am between 18-75 years old and scheduled for a specific spine surgery lasting 2+ hours.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Group 1: Methadone bolus during surgery
- Group 2: No Methadone during surgery
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are doctors looking for new patients to enroll in this trial at the moment?
"As indicated by the clinicaltrials.gov website, this clinical trial is currently open for enrolment. The listing was first posted on 6/6/2022 and most recently updated on 11/16/2022."
How many test subjects are needed for this research?
"The correct, as seen on clinicaltrials.gov this trial is looking for 210 participants and was posted on 6/6/2022. The last update to the study was 11/16/20222"
How do I sign up for this opportunity to participate in research?
"This study, which is looking for a 210 participants, requires that patients have already had spinal surgery and are between 18-75 years old."
Does this study include patients below the age of retirement?
"This study is looking for participants who fall between 18-75 years old."
Has the Methadone drug been federally approved in the United States?
"There is both pre-existing data supporting methadone's efficacy and rounds of safety trials, so it received a score of 3."
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