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Opioid Analgesic
Methadone Dosing for Postoperative Pain
Phase < 1
Recruiting
Led By Nelson Algarra, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Undergoing multilevel thoracic, thoracolumbar and/or lumbar spine surgery with instrumentation and fusion.
At or between the ages 18 to 75 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up changes from baseline (pre-op) up to 72 hours post-op
Awards & highlights
Study Summary
This trial found that a weight-based dosing method of methadone was more effective than a standard dosing method for treating pain after spine surgery.
Who is the study for?
This trial is for individuals aged 18-75 undergoing complex spine surgery with fusion and instrumentation, who consent to participate. It's not for those using methadone or buprenorphine, severely obese people, those with chronic kidney or liver failure, a history of substance abuse, certain heart conditions (prolonged QTc), very high surgical risk (ASA IV/V), or spine issues due to tumor, infection, or trauma.Check my eligibility
What is being tested?
The study compares two ways of giving methadone during complex spine surgeries: the standard dosing method versus titrated doses based on the patient's breathing response. The goal is to see which method better manages postoperative pain.See study design
What are the potential side effects?
Methadone can cause side effects like nausea, vomiting, constipation, lightheadedness or dizziness. In some cases it might lead to slow breathing rates and changes in heartbeat rhythm.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am having spine surgery with hardware and fusion at multiple levels.
Select...
I am between 18 and 75 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ changes from baseline (pre-op) up to 72 hours post-op
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~changes from baseline (pre-op) up to 72 hours post-op
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in opioid requirement for complex spine surgery patients
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Aliquots of methadone titrated to apneaExperimental Treatment1 Intervention
Receive incremental aliquots of methadone up to 0.5 mg/Kg based on ideal body weight titrated to apnea. Each subject will receive a 5-10 mg loading dose then aliquots of 5mg each, given at 3 to 5 minute time intervals. The practitioner will continue to coach patient to take deep breaths. After reaching the apnea threshold as determined by respiratory rate less than 8 breaths/min, induction of general anesthesia and intubation will proceed.
Group II: Standard dosing of methadoneActive Control1 Intervention
Receive 0.2 mg/kg based on ideal body weight of methadone after the intubation and before positioning.
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Who is running the clinical trial?
University of FloridaLead Sponsor
1,340 Previous Clinical Trials
715,615 Total Patients Enrolled
2 Trials studying Postoperative Pain
108 Patients Enrolled for Postoperative Pain
Nelson Algarra, MDPrincipal InvestigatorUniversity of Florida
1 Previous Clinical Trials
100 Total Patients Enrolled
Basma Mohamed, MDPrincipal InvestigatorUniversity of Florida
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am having spine surgery with hardware and fusion at multiple levels.My kidney function is low with high creatinine levels.I have liver failure due to cirrhosis or a severe liver episode.I have a spine condition due to a tumor, infection, or injury.I am currently using methadone or buprenorphine.You currently use or have used drugs in the past.My BMI is over 40, indicating morbid obesity.My health is severely limited by my illness.I am between 18 and 75 years old.You have a history of drinking too much alcohol.You have a history of a heart condition that makes your heart rhythm last longer than it should.
Research Study Groups:
This trial has the following groups:- Group 1: Standard dosing of methadone
- Group 2: Aliquots of methadone titrated to apnea
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research include test subjects who are elderly?
"In order to be included in this trial, patients must be of age (18-65 years old). There are 79 other studies for patients that are under 18 and 424 for patients that are older than 65."
Answered by AI
To be eligible for this experiment, what are the participant requirements?
"This study requires 90 participants, all of whom must be postoperative and between 18-65 years of age. Furthermore, the individuals must meet the following specific criteria: They must have pain and sign the IRB approved informed consent before beginning any study procedures, have undergone multiple thoracolumbar spine surgery with instrumentation and fusion."
Answered by AI
Have there been other medical studies like this one in the past?
"Since 2011, Aliquots of methadone titrated to apnea has been an active area of research with the first clinical trial being completed in the same year. The study was sponsored by Laboratoires Bouchara-Recordati and after the successful completion of the trial with 146 participants, Aliquots of methadone titrated to apnea received its Phase 3 drug approval. As of now, there are 13 active studies being conducted for Aliquots of methadone titrated to apnea across 31 cities in 5 countries."
Answered by AI
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