BridgeMD
Compares treatment options for Pain, Postoperative
Official title Pain Control and Quality of Recovery After Intravenous Methadone Versus Intrathecal Morphine in Major Abdominal Surgery
ClinicalTrials.gov ID: NCT06387303
What this study is testing
What is Methadone?
Methadone is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pain, postoperative.
Also referred to as Intrathecal Methadone.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Moderate to severe postoperative pain is relatively common after major abdominal surgery. It is associated with less than optimal surgical experience, poor quality of recovery, and the development of persistent postsurgical pain.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Adult patients with an American Society of Anesthesiologists (ASA) physiological status I-III
- Undergoing laparotomy with midline incision
- Body mass index (BMI) between 18.5 and 45
- Ability to understand and read English
- Willingness and ability to comply with scheduled visits and study procedures
You likely can't join if
- Not able or unwilling to sign consent
- Patients undergoing ambulatory surgery or anticipated to be discharged sooner than 24 hours after surgery
- Patients with chronic pain, requiring daily opioid use at the time of surgery, MME \>60 as the FDA defines opioid tolerant as 60 MME, long-acting...
- Pregnant Women
- Patients requiring emergent surgery
- Contraindications to neuraxial anesthesia including:
See the full eligibility criteria
- Adult patients with an American Society of Anesthesiologists (ASA) physiological status I-III
- Undergoing laparotomy with midline incision
- Body mass index (BMI) between 18.5 and 45
- Ability to understand and read English
- Willingness and ability to comply with scheduled visits and study procedures
- Not able or unwilling to sign consent
- Patients undergoing ambulatory surgery or anticipated to be discharged sooner than 24 hours after surgery
- Patients with chronic pain, requiring daily opioid use at the time of surgery, MME \>60 as the FDA defines opioid tolerant as 60 MME, long-acting forms of opioids such as fentanyl patch, oxycontin.
- Pregnant Women
- Patients requiring emergent surgery
- Contraindications to neuraxial anesthesia including:
- Coagulopathy
- localized infection at the site of injection
- pre-existing spinal pathology, specifically defined as active radiculopathy, severe central canal stenosis in the lumbar region, or an acute fracture in the lumbar region
- length of the QT interval (QTc) \>450 on the most recent preoperative electrocardiogram (EKG)
- Prior spinal fusion
- Active or Prior Substance Use Disorder, undergoing active treatment with Medication of Opioid Use Disorder including methadone (once daily dosing), Buprenorphine (any formulation) and Naltrexone
The study team makes the final eligibility decision.
Where it's taking place
- Charlottesville, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charlottesville, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.