Spinal Morphine for Postoperative Analgesia in Urology

Comparison of Spinal Morphine With Systemic Analgesia After Urologic Surgery

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03675646

Enrollment

Registered

2018-09-18

Start date

2016-03-05

Completion date

2017-07-10

Last updated

2018-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Keywords

morphine spinal, prostatectomy, nephrectomy

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.

Interventions

DRUGMorphine

Intrathecal injection of 250 mcg preservative-free morphine before surgery

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Masking description

Only ICU personnel was blinded to the method used

Intervention 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.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026