Clinical trial · Interventional
Precision Pain Management for Major Abdominal Surgery in Colorectal Surgery
NCT03455751CI-TRIAL-00037657PPaMterminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Failed to meet enrollment goals
Summary
Brief summary (as posted)
The primary objectives of this study are to evaluate the potential for preoperative pharmacogenomics (PGx) testing to positively influence postoperative opioid use through visual analog scale (VAS) guided administration of narcotic equivalent and lower pain scores as measured by OBAS in patients undergoing major abdominal surgery.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Crohn Disease | — | UNRESOLVED | — |
| Diverticular Disease | — | UNRESOLVED | — |
| Ulcerative Colitis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PGx-guided post-operative pain management | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control
- description
- The control arm will receive no intervention and will follow standard of care for post-operative pain management.
- type
- EXPERIMENTAL
- label
- PGx-guided
- description
- The PGx-guided arm will received altered post-operative pain management based on the results of pharmacogenomic testing.
- interventionNames
- Genetic: PGx-guided post-operative pain management
Primary outcomes (2)
- measure
- Post-operative opioid use
- timeFrame
- Post-op day 1
- description
- Post-operative opioid use through visual analog scale guided administration of narcotic equivalent
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Subject capable of giving consent * Age 18-80 * Scheduled for open colorectal resection at Cleveland Clinic main campus (with preoperative appointment scheduled at least five days before date of surgery) Exclusion Criteria: * Patient does not speak English * Patient with substance-use disorder (including alcohol) * Patient diagnosed with major depression * Patient currently taking opioids * Previous long-term opioid use (\> 3 months) * Previous opioid use with a dose of \>100 milligram morphine equivalent (MME) * Patient has pain-related disorder (e.g. fibromyalgia, sympathetic dystrophy, etc.) * Documented allergy to pain medication
References
Publications (0)
Data not yet available
No reference posted for this study.