Spinal Morphine for Postoperative Analgesia in Urology

NCT ID: NCT03675646

Last Updated: 2018-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-05
• Study Completion Date: 2017-07-10

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.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Morphine

Intervention Type: DRUG

Intrathecal injection of 250 mcg preservative-free morphine before surgery

Control group C

No intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Morphine

Intrathecal injection of 250 mcg preservative-free morphine before surgery

Intervention Type: DRUG

Other Intervention Names

No other names

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charles University, Czech Republic

OTHER

Sponsor Role: lead

Responsible Party

Jiri Malek

Assoc. Prof., M.D., Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jiri Malek, M.D.

Role: PRINCIPAL_INVESTIGATOR

3rd Medical Faculty, Charles University

Locations

University Hospital Kralovske Vinohrady

Prague, , Czechia

Countries

Czechia

Other Identifiers

malekj3

Identifier Type: -

Identifier Source: org_study_id