Spinal Morphine for Postoperative Analgesia in Urology

Pain, Postoperative Clinical Trial

Official title:

Comparison of Spinal Morphine With Systemic Analgesia After Urologic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03675646
• Other study ID #: malekj3
• Status: Completed
• Phase: Phase 4
• Start date: March 5, 2016
• Est. completion date: July 10, 2017

Study information

• Verified date: September 2018
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: July 10, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Morphine
Intrathecal injection of 250 mcg preservative-free morphine before surgery

Locations

Country	Name	City	State
Czechia	University Hospital Kralovske Vinohrady	Praha

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

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