Spinal Morphine for Postoperative Analgesia in Urology | NCT03675646

Studies
Spinal Morphine for Postoperative Analgesia in Urology

NCT03675646

Sponsor

Charles University, Czech Republic

Status

Completed

Last Update Posted

Sep 19, 2018Actual

Enrollment

98Actual

Phase

Phase 4

Conditions

Pain, Postoperative

Interventions

Morphine

Countries

Czechia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 5, 2016Actual

Primary Completion Date

Jun 30, 2017Actual

Completion Date

Jul 10, 2017Actual

First Submitted Date

Aug 23, 2018

First Submission Date that Met QC Criteria

Sep 17, 2018

First Posted Date

Sep 18, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 17, 2018

Last Update Posted Date

Sep 19, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jiri Malek, Assoc. Prof., M.D., Ph.D., Charles University, Czech RepublicPrincipal Investigator

Lead Sponsor

Charles University, Czech RepublicOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

98Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Morphine group M	Experimental	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.	Drug: Morphine
Control group C	No Intervention	No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Morphine	Drug	Intrathecal injection of 250 mcg preservative-free morphine before surgery	Morphine group M

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jiri Malek, M.D.	3rd Medical Faculty, Charles University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Kralovske Vinohrady		Prague		100 00	Czechia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009020	Morphine

Ancestor Terms

ID	Term
D009022	Morphine Derivatives
D009019	Morphinans
D053610	Opiate Alkaloids
D000470	Alkaloids

Browse Leaves

Not provided

Browse Branches

Not provided

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.