Spinal Morphine for Postoperative Analgesia in Urology

Comparison of Spinal Morphine With Systemic Analgesia After Urologic Surgery

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Morphine

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.

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Phase 4

Contacts and Locations

Study Locations

• Czechia
  • Praha, Czechia, 100 00
    • University Hospital Kralovske Vinohrady

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Morphine group M; 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; Intrathecal injection of 250 mcg preservative-free morphine before surgery; Other Names: No other names
NO_INTERVENTION: Control group C; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine side effects	respiratory rate <8, SpO2<90 %, nausea, vomiting, naloxone administration for SpO2<88 %, itching	48 hours

Collaborators and Investigators

• Sponsor: Charles University, Czech Republic
• Investigators: Principal Investigator: Jiri Malek, M.D., 3rd Medical Faculty, Charles University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 5, 2016
• Primary Completion (ACTUAL): June 30, 2017
• Study Completion (ACTUAL): July 10, 2017

Study Registration Dates

• First Submitted: August 23, 2018
• First Submitted That Met QC Criteria: September 17, 2018
• First Posted (ACTUAL): September 18, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 19, 2018
• Last Update Submitted That Met QC Criteria: September 17, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: nephrectomy; prostatectomy; morphine spinal
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: malekj3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No