Comparison of Intrathecal and Intravenous Analgesia in Patients Undergoing Liver Resection

Liver Cancer Clinical Trial

Official title:

Comparison of the Efficacy of Postoperative Analgesia by a Single Dose of Intrathecal Morphine and Intravenous Morphine: a Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03620916
• Other study ID #: 1WB1/2018/1
• Status: Recruiting
• Phase: N/A
• Start date: August 17, 2018
• Est. completion date: January 2019

Study information

• Verified date: August 2018
• Source: Medical University of Warsaw
• Contact: Michal Grat, MD, PhD
• Phone: +48225992541
• Email: michal.grat[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: January 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Cancer
• Liver Diseases
• Liver Metastases
• Liver Neoplasms

Intervention

Procedure:
• Intravenous morphine
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
• Intrathecal morphine
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

Locations

Country	Name	City	State
Poland	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

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of pain at rest	Severity of pain assessed in numerical rating scale twice daily	3 days
Secondary	Severity of pain at coughing	Severity of pain assessed in numerical rating scale twice daily	3 days
Secondary	Morphine usage	Total dose of morphine administered intravenously and subcutaneously	3 days
Secondary	Time to mobilization	Time to self-standing after the operation	90 days
Secondary	Grade of sedation	Richmond Agitation and Sedation Scale	3 days
Secondary	Solid food tolerance	Time to solid food intake	90 days
Secondary	Duration of hospitalization	Postoperative hospital stay	90 days
Secondary	Postoperative complications	Postoperative complications according to Clavien-Dindo classification	90 days