Clinical trial · Interventional
Spinal Versus Epidural Analgesia in Laparotomic Liver Surgery
Spinal Analgesia Versus Epidural Analgesia in Minor Laparotomic Liver Surgery in an Enhanced Recovery Programme: A Randomized Controlled Trial
NCT02647047CI-TRIAL-00020447unknownN/AClinicalTrials.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)
The purpose of this study is to evaluate the efficacy of spinal analgesia for minor laparotomic hepatectomy compared with epidural analgesia, monitoring visual analog scale (VAS). The investigators expect at least the same post-operative pain control in the two groups (non inferiority of pain control with spinal analgesia compared to epidural analgesia). Second endpoint is to verify whether after spinal analgesia there is a decrease in patient's length of hospitalization according to enhanced recovery after surgery (ERAS) principles.
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 |
|---|---|---|---|
| Liver Diseases | — | UNRESOLVED | — |
| Liver Neoplasms | Liver Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Secondary Malignant Neoplasm of Liver | — | UNRESOLVED | — |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acetaminophen | Drug | — | UNRESOLVED |
| Epidural analgesia | Procedure | — | UNRESOLVED |
| Ketorolac | Drug | — | UNRESOLVED |
| Ropivacaine | Drug | — | UNRESOLVED |
| Spinal analgesia | Procedure | — | UNRESOLVED |
| Sufentanil | Drug | — | UNRESOLVED |
| Surgical wound infiltration | Procedure | — | UNRESOLVED |
| Transversus Abdominis Plane block | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Spinal
- description
- Patients will receive spinal analgesia (morphine 0.2 mg) before general anesthesia for minor laparotomic liver resection.
- interventionNames
- Procedure: Spinal analgesia
- Procedure: Transversus Abdominis Plane block
- Procedure: Surgical wound infiltration
- Drug: Acetaminophen
- Drug: Ketorolac
- Drug: Ropivacaine
- type
- ACTIVE_COMPARATOR
- label
- Epidural
- description
- Patients will receive epidural analgesia (bolus of ropivacaine 0.2% 4-6 mL followed by continuous epidural infusion of ropivacaine 0.2% 99 mL + sufentanil 50 mcg/mL 1 mL) before general anesthesia for minor laparotomic liver resection.
- interventionNames
- Procedure: Epidural analgesia
- Drug: Acetaminophen
- Drug: Ketorolac
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 years old * Hospitalized patients * Surgical indication for minor laparotomic anterior liver resection (II, III, IV and V hepatic segment resection) * Surgical indication for laparotomic liver metastasectomy * Ability to provide an informed consent Exclusion Criteria: * Patient refusal to provide informed consent * Chronical therapy with opioids * Pregnancy or breastfeeding * Alcohol or drug abuse * Planned or unplanned post-operative intensive care unit admission * Contraindication to spinal/epidural analgesia * Severe liver or renal failure * Cognitive disorders, mental retard or psychiatric disorders * Allergy to any drug used
References
Publications (6)
- BACKGROUNDTzimas P, Prout J, Papadopoulos G, Mallett SV. Epidural anaesthesia and analgesia for liver resection. Anaesthesia. 2013 Jun;68(6):628-35. doi: 10.1111/anae.12191. PMID 23662750
- BACKGROUNDRevie EJ, Massie LJ, McNally SJ, McKeown DW, Garden OJ, Wigmore SJ. Effectiveness of epidural analgesia following open liver resection. HPB (Oxford). 2011 Mar;13(3):206-11. doi: 10.1111/j.1477-2574.2010.00274.x. PMID 21309939
- BACKGROUNDKasivisvanathan R, Abbassi-Ghadi N, Prout J, Clevenger B, Fusai GK, Mallett SV. A prospective cohort study of intrathecal versus epidural analgesia for patients undergoing hepatic resection. HPB (Oxford). 2014 Aug;16(8):768-75. doi: 10.1111/hpb.12222. Epub 2014 Jan 28. PMID 24467320
- BACKGROUNDNtinas A, Kardassis D, Konstantinopoulos I, Kottos P, Manias A, Kyritsi M, Zilianiaki D, Vrochides D. Duration of the thoracic epidural catheter in a fast-track recovery protocol may decrease the length of stay after a major hepatectomy: a case control study. Int J Surg. 2013;11(9):882-5. doi: 10.1016/j.ijsu.2013.07.014. Epub 2013 Aug 4. PMID 23924906
- BACKGROUNDKoea JB, Young Y, Gunn K. Fast track liver resection: the effect of a comprehensive care package and analgesia with single dose intrathecal morphine with gabapentin or continuous epidural analgesia. HPB Surg. 2009;2009:271986. doi: 10.1155/2009/271986. Epub 2009 Dec 15. PMID 20029637
- BACKGROUNDHughes MJ, McNally S, Wigmore SJ. Enhanced recovery following liver surgery: a systematic review and meta-analysis. HPB (Oxford). 2014 Aug;16(8):699-706. doi: 10.1111/hpb.12245. Epub 2014 Mar 24. PMID 24661306