Spinal Morphine for Postoperative Analgesia in Urology

NCT03675646 | Completed Phase 4

• 1 other identifier: malekj3
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Keywords

morphine spinal; prostatectomy; nephrectomy

Outcome Measures

Primary Outcomes (1)

• 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)

  48 hours

Secondary Outcomes (1)

• Morphine side effects

  48 hours

Study Arms (2)

Morphine group M

EXPERIMENTAL

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.

Drug: Morphine

Control group C

NO INTERVENTION

No intervention

Interventions

Morphine DRUG

Intrathecal injection of 250 mcg preservative-free morphine before surgery

Also known as: No other names

Morphine group M

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elicited open prostatectomy or open nephrectomy

You may not qualify if:

• drug or alcohol dependence
• psychiatric drug use
• ASA classification IV or V
• general contraindication to neuroaxial injection

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Study Sites (1)

University Hospital Kralovske Vinohrady

Prague, 100 00, Czechia

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Morphine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Jiri Malek, M.D.

  3rd Medical Faculty, Charles University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Only ICU personnel was blinded to the method used
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof., M.D., Ph.D.

Model Details: 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.

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: September 18, 2018
• Study Start: March 5, 2016
• Primary Completion: June 30, 2017
• Study Completion: July 10, 2017
• Last Updated: September 19, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)