Clinical trial · Interventional
Local Anesthetic Wound Infusion and Functional Recovery After Colon Surgery
Postoperative Determinants of Functional Recovery Following Colon Surgery: The Effect of Wound Infiltration With Local Anesthetics
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low recruitment rate - \>70% of colorectal procedures are done laparoscopically
Summary
Brief summary (as posted)
This is a double blinded randomized controlled trial in patients undergoing colon open surgery. The purpose is to evaluate the effectiveness of two different analgesic techniques on functional recovery after surgery. Twenty five patients will receive thoracic epidural analgesia plus patient controlled analgesia (PCA) (epidural analgesia group) and 25 patients wound infiltration of local anesthetic plus PCA (wound infusion group). Hypothesis: the postoperative recovery of patients receiving local anesthetic wound infusion will be faster than patients receiving thoracic epidural analgesia. Functional recovery, pain intensity, opioid consumption and side effects, length of hospital stay and biological markers of inflammation after surgery will be measured in both groups.
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 |
|---|---|---|---|
| Epidural analgesia | Procedure | — | UNRESOLVED |
| Wound catheter | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Epidural analgesia group
- description
- patients in the epidural analgesia group will receive ropivacaine 0.2% through the epidural catheter, normal saline in the wound catheter and PCA with morphine.
- interventionNames
- Procedure: Epidural analgesia
- type
- EXPERIMENTAL
- label
- Wound Group
- description
- patients in the epidural analgesia group will receive ropivacaine 0.2% through the wound catheter, normal saline in the epidural catheter and PCA with morphine.
- interventionNames
- Procedure: Wound catheter
Primary outcomes (1)
- measure
- Postoperative functional recovery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * patients undergoing elective open colon surgery Exclusion Criteria: * ASA physical status 4 * history of: * hepatic failure (liver enzymes abnormally elevated) * renal failure (creatinine over 150 mmol/L) * cardiac failure * organ transplant * diabetes * morbid obesity (BMI \> 40 kg/m-2) * chronic use of opioids * allergy to local anaesthetics * History of seizure * contraindications to the insertion of epidural * INR \> 1.3, PTT \> 44 second, platelets \< 150.000 per microliter, * previous spinal surgery limiting the insertion) * inability to comprehend pain assessment
References
Publications (0)
Data not yet available