Status:
COMPLETED
Intrathecal Opioids for Colorectal Resection
Lead Sponsor:
Mayo Clinic
Conditions:
Colorectal Surgery
Pain, Postoperative
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
This research study is being done to determine the optimal dose of spinal morphine and hydromorphone in patients undergoing minimally-invasive (i.e., surgery performed through small entry sites and us...
Detailed Description
Intrathecal (IT) opioids have been established as a safe and efficacious modality to treat postoperative pain. In the setting of colorectal surgery, studies have shown that intrathecal opioids togethe...
Eligibility Criteria
Inclusion
- Adult patients with an American Society of Anesthesiologists (ASA) physiological status I-III.
- Undergoing colorectal minimally invasive surgery (MIS).
- Age between 18 and 75 years of age.
- Body mass index (BMI) between 18.5 and 40.
- Ability to understand and read English.
Exclusion
- Not able or unwilling to sign consent.
- Patients undergoing ileostomy closure.
- 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.
- Patient intolerant or allergic to opioids, NSAIDs, or acetaminophen.
- Patients requiring emergent surgery.
- Any contraindication to neuraxial anesthesia (coagulopathy, localized infection at the site of injection, pre-existing spinal pathology, or peripheral neuropathy).
- Any patients currently receiving any anticoagulation medication other than aspirin and who have not discontinued the medication per American Society of Regional Anesthesia anticoagulation guidelines22, and/or an abnormal INR.
- Patients with hepatic or renal insufficiency in as much as the patient is not a candidate for acetaminophen or NSAIDs, respectively.
Key Trial Info
Start Date :
March 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 17 2023
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04752033
Start Date
March 10 2021
End Date
February 17 2023
Last Update
March 26 2024
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905