Spinal Morphine for Postoperative Analgesia in Urology
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Phase 4
Locations
Czechia
Study Type
Interventional
Intervention
Morphine
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring morphine spinal, prostatectomy, nephrectomy
Eligibility Criteria
Inclusion Criteria
- elicited open prostatectomy or open nephrectomy
Exclusion Criteria
- drug or alcohol dependence
- psychiatric drug use
- ASA classification IV or V
- general contraindication to neuroaxial injection
Sites / Locations
- University Hospital Kralovske Vinohrady
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Morphine group M
Control group C
Arm Description
Experimental group M were administered preservative-free morphine 250 mcg in 2.5 ml NS intrathecal using 25 G needle in L1/2 - L5/S1 interspaces.
No intervention
Outcomes
Primary Outcome Measures
Duration of analgesia
Time to the first morphine request during the first two days of ICU stay after surgery (in hours) and total morphine consumption during the first two days of ICU stay (in mg)
Secondary Outcome Measures
Morphine side effects
respiratory rate <8, SpO2<90 %, nausea, vomiting, naloxone administration for SpO2<88 %, itching
Full Information
NCT ID
NCT03675646
First Posted
August 23, 2018
Last Updated
September 17, 2018
Sponsor
Charles University, Czech Republic
1. Study Identification
Unique Protocol Identification Number
NCT03675646
Brief Title
Spinal Morphine for Postoperative Analgesia in Urology
Official Title
Comparison of Spinal Morphine With Systemic Analgesia After Urologic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
March 5, 2016 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
July 10, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charles University, Czech Republic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study was performed in urology patients elicited for open prostatectomy or open nephrectomy. Comparison of analgesic effect between group (M) with spinal morphine before general anaesthesia and group without this intervention was measured.
Detailed Description
Patients elicited for open prostatectomy or open nephrectomy were randomly divided in 2 groups. Group M were administered preservative-free morphine 250 mcg in 2.5 ml NS intrathecal using 25 G needle in L1/2 - L5/S1 interspaces. Control group (C) were given no intervention. Placebo intrathecal injection in C was not used because of ethical reason. Standard general anaesthesia was used in both groups. After surgery all patients were transferred to urology ICU and were given standard analgesic regimen according to level of pain measured by numeric rating scale (NRS) 0 - 10: NRS > 3 metamizol 1 g IV every 6 h., max. 4 g/24 h., NRS > 3 paracetamol 1g IV every 6 h., max. 4 g/24 h., NRS > 3 lasting 30 min. after administration of previous ones diclofenac 75 mg IM á 12 h., max. 150 mg/24 h., NRS > 4 morphine 10 mg SC á 6 h. Personnel of ICU was blinded to the analgesic method used.
Noticed parameters: pain intensity (NRS), time to NRS ≥ 4, time to the first morphine request, side effects (respiratory rate <8, SpO2<90 %, nausea, vomiting, naloxone administration for SpO2<88 %, itching).
Standard statistical analysis was used, p value < 0.05 was considered significant.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
morphine spinal, prostatectomy, nephrectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Patient elicited for open prostatectomy or open nephrectomy were given intrathecal morphine in normal saline before induction to general anaesthesia (GA) or GA only. After surgery, time to the first opioid request, total opioid consumption during first 24 hours and 48 hours after surgery and opioid side effects were noticed.
Masking
Outcomes Assessor
Masking Description
Only ICU personnel was blinded to the method used
Allocation
Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Morphine group M
Arm Type
Experimental
Arm Description
Experimental group M were administered preservative-free morphine 250 mcg in 2.5 ml NS intrathecal using 25 G needle in L1/2 - L5/S1 interspaces.
Arm Title
Control group C
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Drug
Intervention Name(s)
Morphine
Other Intervention Name(s)
No other names
Intervention Description
Intrathecal injection of 250 mcg preservative-free morphine before surgery
Primary Outcome Measure Information:
Title
Duration of analgesia
Description
Time to the first morphine request during the first two days of ICU stay after surgery (in hours) and total morphine consumption during the first two days of ICU stay (in mg)
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Morphine side effects
Description
respiratory rate <8, SpO2<90 %, nausea, vomiting, naloxone administration for SpO2<88 %, itching
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
elicited open prostatectomy or open nephrectomy
Exclusion Criteria
drug or alcohol dependence
psychiatric drug use
ASA classification IV or V
general contraindication to neuroaxial injection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiri Malek, M.D.
Organizational Affiliation
3rd Medical Faculty, Charles University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Kralovske Vinohrady
City
Praha
ZIP/Postal Code
100 00
Country
Czechia
12. IPD Sharing Statement
Plan to Share IPD
No
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Spinal Morphine for Postoperative Analgesia in Urology
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