Comparison of Intrathecal and Intravenous Analgesia in Patients Undergoing Liver Resection
- Conditions
- Liver CancerLiver DiseasesLiver Metastases
- Interventions
- Procedure: Intravenous morphineProcedure: Intrathecal morphine
- Registration Number
- NCT03620916
- Lead Sponsor
- Medical University of Warsaw
- Brief Summary
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.
- Detailed Description
Effective analgesia in patients undergoing liver resection is an important measure to enhance the process of postoperative recovery. 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 patients scheduled for liver resection in the Department of General, Transplant and Liver Surgery (Medical University of Warsaw) will be screened for eligibility basing on inclusion and exclusion criteria. Eligible patients will be included in the study following provision of informed consent. Randomization will be performed immediately before the surgical procedure in the operating theatre. 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. Side effects of intrathecal morphine injection and intravenous morphine administration will be monitored. The thresholds for type I and type II errors will be set at 0.05 and 0.20, respectively.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 36
- liver resection
- liver malignancy
- >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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intravenous morphine Intravenous morphine Intravenous morphine (0,15 mg/kg body mass) immediately after the operation Intrathecal morphine Intrathecal morphine Intrathecal morphine (0,4 mg) immediately before operation
- Primary Outcome Measures
Name Time Method Severity of pain at rest 3 days Severity of pain assessed in numerical rating scale twice daily
- Secondary Outcome Measures
Name Time Method Time to mobilization 90 days Time to self-standing after the operation
Postoperative complications 90 days Postoperative complications according to Clavien-Dindo classification
Severity of pain at coughing 3 days Severity of pain assessed in numerical rating scale twice daily
Morphine usage 3 days Total dose of morphine administered intravenously and subcutaneously
Grade of sedation 3 days Richmond Agitation and Sedation Scale
Solid food tolerance 90 days Time to solid food intake
Duration of hospitalization 90 days Postoperative hospital stay
Trial Locations
- Locations (2)
Department of General, Transplant and Liver Surgery, Medical University of Warsaw
🇵🇱Warsaw, Mazowieckie, Poland
II Department of Anaesthesiology and Intensive Care, Medical University of Warsaw
🇵🇱Warsaw, Mazowieckie, Poland