Phase 4
N=80
Intrathecal Opioids for Colorectal Resection
Colorectal Surgery · Pain, Postoperative · Analgesic, Opioid
Bottom Line
View on ClinicalTrials.gov: NCT04752033 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Postoperative Pain Control — 4.5; 1.6; 1.75; 2.75 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Morphine (Drug); Hydromorphone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative Pain Control |
3; 2.2; 2.25; 3; 4.25; 7 | — |
| SECONDARY Postoperative Pain Control |
3; 2.2; 2.25; 3; 4.25; 7 | — |
| SECONDARY Presence and Severity of Opioid-related Side Effects at Their Highest Doses |
1; 2; 1; 3; 0; 1 | — |
| SECONDARY Overall Benefits of Analgesia Score (OBAS) |
5.5; 4.8; 2.33; 3.5; 4.5; 3 | — |
| SECONDARY Quality of Recovery (QoR) 15 Score |
114.5; 120.5; 108.5; 123.75; 106.25; 131 | — |
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 using cameras) colorectal surgery.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04752033). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.