Clinical trial · Interventional
Comparison of Intrathecal and Intravenous Analgesia in Patients Undergoing Liver Resection
Comparison of the Efficacy of Postoperative Analgesia by a Single Dose of Intrathecal Morphine and Intravenous Morphine: a Randomized Trial
- 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 aim of this prospective, interventional, randomized trial is to compare the effectiveness of postoperative analgesia using single-dose intrathecal morphine and intravenous morphine in patients undergoing liver resection. The study is to include a total 36 patients randomized in a 1:1 ratio into two groups. The study will be single-blinded with respect to outcome assessors. Patients in the experimental group (n=18) will receive a single dose (0,4 mg) intrathecal morphine immediately before operation and patient-controlled analgesia (PCA) with morphine over first 24 postoperative hours and subcutaneous morphine (5 mg in case of numerical rating scale\>4) over next two days in the postoperative period. Patients in the control group (n=18) will receive a single dose of intravenous morphine (0,15 mg/kg body mass) immediately after the operation and PCA with morphine over first 24 postoperative hours and subcutaneous morphine (5 mg in case of numerical rating scale\>4) over next two days. Both groups will receive antiemetic prophylaxis with dexamethasone (4 mg) and ondansetron (4 mg) and standard baseline analgesia with paracetamol (1,0 g every 6 hours) and dexketoprofen (50 mg every 8 hours). Severity of pain at rest evaluated with numerical rating scale twice daily over 3 first postoperative days will be the primary outcome measure. Secondary outcome measures will include: severity of pain at coughing evaluated with numerical rating scale twice daily over 3 first postoperative days, total dose of morphine administered with PCA, time to patient mobilization, grade of sedation, intestinal motility, solid food intake tolerance, duration of hospitalization, and postoperative complications.
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 Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Liver Diseases | — | UNRESOLVED | — |
| Liver Metastases | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intrathecal morphine | Procedure | — | UNRESOLVED |
| Intravenous morphine | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intrathecal morphine
- description
- Intrathecal morphine (0,4 mg) immediately before operation
- interventionNames
- Procedure: Intrathecal morphine
- type
- ACTIVE_COMPARATOR
- label
- Intravenous morphine
- description
- Intravenous morphine (0,15 mg/kg body mass) immediately after the operation
- interventionNames
- Procedure: Intravenous morphine
Primary outcomes (1)
- measure
- Severity of pain at rest
- timeFrame
- 3 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * liver resection * liver malignancy Exclusion Criteria: * \>3 points in American Society of Anesthesiology (ASA) scale * contra-indications for intrathecal morphine administration * chronic preoperative intake of analgetics * a history of opioid dependency * body mass index \>45 kg/m2 * allergy to any analgetic drug administered in the study
References
Publications (1)
- DERIVEDNiewinski G, Figiel W, Grat M, Dec M, Morawski M, Patkowski W, Zieniewicz K. A Comparison of Intrathecal and Intravenous Morphine for Analgesia After Hepatectomy: A Randomized Controlled Trial. World J Surg. 2020 Jul;44(7):2340-2349. doi: 10.1007/s00268-020-05437-x. PMID 32112166