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
1 other identifier
interventional
36
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2018
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 2, 2018
CompletedFirst Posted
Study publicly available on registry
August 8, 2018
CompletedStudy Start
First participant enrolled
August 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedOctober 4, 2018
August 1, 2018
4 months
August 2, 2018
October 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Severity of pain at rest
Severity of pain assessed in numerical rating scale twice daily
3 days
Secondary Outcomes (7)
Severity of pain at coughing
3 days
Morphine usage
3 days
Time to mobilization
90 days
Grade of sedation
3 days
Solid food tolerance
90 days
- +2 more secondary outcomes
Study Arms (2)
Intrathecal morphine
EXPERIMENTALIntrathecal morphine (0,4 mg) immediately before operation
Intravenous morphine
ACTIVE COMPARATORIntravenous morphine (0,15 mg/kg body mass) immediately after the operation
Interventions
Single dose of intravenous morphine (0,15 mg/kg body mass) immediately after the operation, patient controlled analgesia with morphine (2 mg intravenously, a least 20 min interval) over first 24 postoperative hours and subcutaneous morphine (5 mg in case of numerical rating scale\>4, at least 6 hour interval) over next two days
Single dose (0,4 mg) intrathecal morphine immediately before operation, patient-controlled analgesia with morphine (2 mg intravenously, a least 20 min interval) over first 24 postoperative hours and subcutaneous morphine (5 mg in case of numerical rating scale\>4, at least 6 hour interval) over next two days in the postoperative period
Eligibility Criteria
You may qualify if:
- liver resection
- liver malignancy
You may not qualify if:
- \>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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Department of General, Transplant and Liver Surgery, Medical University of Warsaw
Warsaw, Masovian Voivodeship, 02-097, Poland
II Department of Anaesthesiology and Intensive Care, Medical University of Warsaw
Warsaw, Masovian Voivodeship, 02-097, Poland
Related Publications (1)
Niewinski 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: 32112166DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Grzegorz Niewiński, MD, PhD
Medical University of Warsaw
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2018
First Posted
August 8, 2018
Study Start
August 17, 2018
Primary Completion
December 1, 2018
Study Completion
January 1, 2019
Last Updated
October 4, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share