Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06351215
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-08
First Post:
2024-04-01
Brief Title:
PO Methadone Ortho Outpatient
Sponsor:
Keck School of Medicine of USC
Organization:
Keck School of Medicine of USC
Study Overview
Official Title:
Use of Single-Dose Oral Methadone for Pain Management in Outpatient Arthroscopic Hip and Knee Procedures
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if oral methadone given before surgery works to minimize post-operative pain and opioid usage The main questions it aims to answer are
Does oral methadone improve post-operative pain scores as compared to standard treatment Does oral methadone lead to reduced use of post-operative and post-discharge opioid usage as compared to the current standard treatment
Researchers will compare oral methadone to a placebo a look-alike substance that contains no drug to assess the questions above
Participants will
Receive either oral methadone or a look-alike placebo before surgery Receive standard intraoperative and immediate post-operative pain control at the anesthesiologists discretion Be asked about their pain levels in the recovery area Keep a diary of pain and opioid usage over the first 2 days after surgery
Does oral methadone improve post-operative pain scores as compared to standard treatment Does oral methadone lead to reduced use of post-operative and post-discharge opioid usage as compared to the current standard treatment
Researchers will compare oral methadone to a placebo a look-alike substance that contains no drug to assess the questions above
Participants will
Receive either oral methadone or a look-alike placebo before surgery Receive standard intraoperative and immediate post-operative pain control at the anesthesiologists discretion Be asked about their pain levels in the recovery area Keep a diary of pain and opioid usage over the first 2 days after surgery
Detailed Description:
STUDY METHOD We plan to perform a double-blinded randomized control study where the participants anesthesiologist data collectors and study team will be unaware of the intervention offered Participants will be randomly assigned to the control group standard intraoperative pain control using short-acting opioids with drug choice and dosing at the practitioners discretion or to the intervention group a single dose of perioperative oral methadone
Patients will be recruited and consented to whether they want to participate in the study by a member of the team during a pre-operative clinic visit Anesthesia START clinic or orthopedic surgery clinic or on day-of-surgery in the pre-op holding area
Participants will be randomized to either the control group or treatment group using randomization software Participants assigned to the intervention group will receive a single dose of oral methadone will be administered in the pre-operative holding area Dosing will be weight dependent using 015mgkg ideal body weight IBW as a reference participants weighing less than 50kg will receive 5mg oral methadone while participants weighing more than 50kg will receive 10mg oral methadone Participants assigned to the control group will receive an identical-looking placebo sugar pill A study pharmacist will deliver the appropriate pill to the patient or pre-op nurse in the pre-op holding area on the day of surgery
Pre-operatively all participants will complete a survey collecting data on visual analog scale VAS pain scores for the 2 weeks leading up to surgery whether this is different from their baseline pain score at home if applicable and pre-operative opioid usage if applicable All participants will receive standard-of-care pre-operative non-opioid medications as determined by the orthopedic surgical team if needed
Intraoperatively participants will receive either GA or monitored anesthesia care at the discretion of the anesthesia care team
In the post-anesthesia acute care unit PACU all participants will receive standard PACU medications ie intravenous dilaudid or oral oxycodone and acetaminophen as needed for pain relief Pain scores on a 1-10 scale and amount of opioid usage will be collected per standard PACU protocol upon arrival after 30 minutes and after 60 minutes Post-discharge all participants will receive oxycodone-acetaminophen for at-home pain as standardized by the orthopedic surgery team to be used as needed for breakthrough pain refractory to acetaminophenibuprofen or in patients where these medications are contraindicated
Following discharge a member of the study team will call participants on post-operative day 1 and post-operative day 2 to assess pain scores and opioid usage Participants will also be discharged with a pain diary to assist in documenting endpoints They will also be asked to document any complications or adverse events at each of these time intervals
Once the data collection is complete we will perform statistics detailed below to determine if there is any significant difference The primary outcome will be post-discharge opioid usage and the secondary outcome will be patient-perceived pain scores at the time intervals above
STRATIFICATIONDESCRIPTIVE FACTORSRANDOMIZATION SCHEME
Participants will not be stratified prior to randomization
Descriptive factors age gender BMI will be looked to assess for possible confounding variables but will not affect group assignment
The website randomizerorg will assist in our randomization of participants enrolled in the study The software randomly determines which participant will be assigned to Control vs Treatment group in a 11 ratio At the onset of the study we will create a predetermined randomization list containing study participant code and treatment arm assignment and provide it to the study pharmacist who will then be the only one with access to this linked info The study pharmacist will be informed of the new enrollment and will read back the study code to the team member who will record it in a separate data collection form that contains link between Medical Record Number and participant code The pharmacist will strike out the participant code on their sheet to keep track of used codes then prepare the appropriate medication and deliver it to the participant or pre-op nurse in the pre-op holding area on the day of surgery
Patients will be recruited and consented to whether they want to participate in the study by a member of the team during a pre-operative clinic visit Anesthesia START clinic or orthopedic surgery clinic or on day-of-surgery in the pre-op holding area
Participants will be randomized to either the control group or treatment group using randomization software Participants assigned to the intervention group will receive a single dose of oral methadone will be administered in the pre-operative holding area Dosing will be weight dependent using 015mgkg ideal body weight IBW as a reference participants weighing less than 50kg will receive 5mg oral methadone while participants weighing more than 50kg will receive 10mg oral methadone Participants assigned to the control group will receive an identical-looking placebo sugar pill A study pharmacist will deliver the appropriate pill to the patient or pre-op nurse in the pre-op holding area on the day of surgery
Pre-operatively all participants will complete a survey collecting data on visual analog scale VAS pain scores for the 2 weeks leading up to surgery whether this is different from their baseline pain score at home if applicable and pre-operative opioid usage if applicable All participants will receive standard-of-care pre-operative non-opioid medications as determined by the orthopedic surgical team if needed
Intraoperatively participants will receive either GA or monitored anesthesia care at the discretion of the anesthesia care team
In the post-anesthesia acute care unit PACU all participants will receive standard PACU medications ie intravenous dilaudid or oral oxycodone and acetaminophen as needed for pain relief Pain scores on a 1-10 scale and amount of opioid usage will be collected per standard PACU protocol upon arrival after 30 minutes and after 60 minutes Post-discharge all participants will receive oxycodone-acetaminophen for at-home pain as standardized by the orthopedic surgery team to be used as needed for breakthrough pain refractory to acetaminophenibuprofen or in patients where these medications are contraindicated
Following discharge a member of the study team will call participants on post-operative day 1 and post-operative day 2 to assess pain scores and opioid usage Participants will also be discharged with a pain diary to assist in documenting endpoints They will also be asked to document any complications or adverse events at each of these time intervals
Once the data collection is complete we will perform statistics detailed below to determine if there is any significant difference The primary outcome will be post-discharge opioid usage and the secondary outcome will be patient-perceived pain scores at the time intervals above
STRATIFICATIONDESCRIPTIVE FACTORSRANDOMIZATION SCHEME
Participants will not be stratified prior to randomization
Descriptive factors age gender BMI will be looked to assess for possible confounding variables but will not affect group assignment
The website randomizerorg will assist in our randomization of participants enrolled in the study The software randomly determines which participant will be assigned to Control vs Treatment group in a 11 ratio At the onset of the study we will create a predetermined randomization list containing study participant code and treatment arm assignment and provide it to the study pharmacist who will then be the only one with access to this linked info The study pharmacist will be informed of the new enrollment and will read back the study code to the team member who will record it in a separate data collection form that contains link between Medical Record Number and participant code The pharmacist will strike out the participant code on their sheet to keep track of used codes then prepare the appropriate medication and deliver it to the participant or pre-op nurse in the pre-op holding area on the day of surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None