Phase 4
Completed N=80
Intrathecal Opioids for Colorectal Resection
Colorectal Surgery · Pain, Postoperative · Analgesic, Opioid
Source: ClinicalTrials.gov NCT04752033 ↗
Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcomePrimary: Postoperative Pain Control — 4.5; 1.6; 1.75; 2.75 score on a scale
◆ Published Evidence
Emerging
2citations · ~2 / year
A Prospective Randomized Dose-Finding Study of Intrathecal Opioids for Postoperative Analgesia After Minimally Invasive Colorectal Operation.
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.
Linked Publications
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A Prospective Randomized Dose-Finding Study of Intrathecal Opioids for Postoperative Analgesia After Minimally Invasive Colorectal Operation.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.