Spinal Morphine for Postoperative Analgesia in Urology

Phase 4

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: Morphine

• Registration Number: NCT03675646
• Lead Sponsor: Charles University, Czech Republic

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.

Study Timeline

• Study Start: 2016-03-05
• Primary Completion: 2017-06-30
• Study Completion: 2017-07-10
• Study First Submitted: 2018-08-23
• Status Verified: 2018-09
• Study First Submitted QC: 2018-09-17
• Last Update Submitted: 2018-09-17
• Study First Posted: 2018-09-18
• Last Update Posted: 2018-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Morphine group M	Morphine	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.

Primary Outcome Measures

Name	Time	Method
Duration of analgesia	48 hours	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

Name	Time	Method
Morphine side effects	48 hours	respiratory rate \<8, SpO2\<90 %, nausea, vomiting, naloxone administration for SpO2\<88 %, itching

Trial Locations

Locations (1)

University Hospital Kralovske Vinohrady; 🇨🇿 Praha, Czechia