Clinical trial · Interventional
Spinal Analgesia for Colonic Resection Using an Enhanced Recovery After Surgery (ERAS) Program
NCT01477190CI-TRIAL-00005819completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a blinded randomized controlled trial in patients undergoing laparoscopic colon surgery. The aim of this study is to assess whether spinal analgesia with a mixture of bupivacaine and morphine provides better pain relief than systemic morphine in a group of patients undergoing colonic resection and using the Enhanced Recovery After Surgery (ERAS) program. Twenty patients will receive spinal analgesia and twenty patients will receive only Patient Control Analgesia (PCA).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Diverticulitis | — | UNRESOLVED | — |
| Inflammatory Bowel Diseases | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patient Control Analgesia (PCA) Morphine | Drug | — | UNRESOLVED |
| Spinal analgesia | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Spinal group
- description
- Isobaric bupivacaine 0.5% 10 mg together with preservative-free morphine was injected. The dose of morphine was based on patient's age, with 200 μg in patients aged ≤ 75 years and 150 μg in patients aged \> 75 years.
- interventionNames
- Drug: Spinal analgesia
- type
- ACTIVE_COMPARATOR
- label
- PCA group
- description
- PCA Morphine is set to the patient for 48 hours postoperative. 2 mg. of morphine is given to a patient as much as patient requires, maximum at every 7 minutes.
- interventionNames
- Drug: Patient Control Analgesia (PCA) Morphine
Primary outcomes (1)
- measure
- postoperative pain
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * patients scheduled to undergo laparoscopic colonic resection Exclusion Criteria: * patients who have trouble to understand, read or communicate either in French or in English * dementia * patients suffering from severe physical disability (arthritis, neuromuscular dysfunction, stroke, paraplegia) or inability to walk or conduct daily activity * patients suffering from severe cardiac or respiratory disease (status ASA IV) * patients suffering from metastatic carcinoma * patients who have a history of chemoradiation within the six months preceding surgery * morbid obesity * contraindication to spinal analgesia
References
Publications (0)
Data not yet available
No reference posted for this study.