NCT03675646

Spinal Morphine for Postoperative Analgesia in Urology

Comparison of Spinal Morphine With Systemic Analgesia After Urologic Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Charles University, Czech Republic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	Morphine	Intrathecal injection of 250 mcg preservative-free morphine before surgery

Timeline

• Start date: 2016-03-05
• Primary completion: 2017-06-30
• Completion: 2017-07-10
• First posted: 2018-09-18
• Last updated: 2018-09-19

Locations

1 site across 1 country: Czechia