The Safety and Efficacy of Epidural Oxycodone | NCT02573909

Studies
The Safety and Efficacy of Epidural Oxycodone

NCT02573909

Sponsor

Kuopio University Hospital

Status

Unknown status

Last Update Posted

Mar 16, 2023Actual

Enrollment

100Estimated

Phase

Phase 4

Conditions

Pain, Postoperative

Interventions

Oxycodone intravenously
Oxycodone epidurally

Countries

Finland

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

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2015Actual

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Oct 8, 2015

First Submission Date that Met QC Criteria

Oct 9, 2015

First Posted Date

Oct 12, 2015Estimated

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

Mar 14, 2023

Last Update Posted Date

Mar 16, 2023Actual

Name	Class
Admescope Ltd	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

There are conflicting results in earlier studies concerning the safety and efficacy of epidural oxycodone. In a study by Bäcklund and colleagues, epidural oxycodone was as effective as intravenous oxycodone, so they did not recommend epidural use of oxycodone. In another study, Yanagidate and Dohi reported that oxycodone was as effective in pain treatment with double dose compared to epidural morphine. In our previous study, epidural oxycodone provided safe and effective pain relief when compared to intravenous oxycodone.

In the present study, the aim was to compare the efficacy and safety of epidural or intravenous oxycodone in patients undergoing elective gynecological surgery with planned epidural pain treatment.

Detailed Description

Not provided

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oxycodone intravenously	Experimental	Oxycodone 0,1 mg/kg IV	Drug: Oxycodone epidurally
Oxycodone epidurally	Experimental	Oxycodone 0,1 mg/kg epidurally	Drug: Oxycodone intravenously

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oxycodone intravenously	Drug	Oxycodone intravenously 0,1mg/kg	Oxycodone epidurally

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
amount of rescue medicine	The amount of rescue pain medication given after study drug administration up to four hours	from zero hours up to four hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Planned gynecological lower abdomen surgery with epidural pain treatment
Informed consent obtained

Exclusion Criteria:

Planned surgery under regional anesthesia
contraindication to the study drug
contraindication to the lumbar puncture
Contraindication to oxycodone
Pregnancy or lactation
no informed consent

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Merja Kokki, PhD	Kuopio University Hospital, Kuopio, Finland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kuopio University Hospital		Kuopio	Northern Savonia	70029	Finland

IPD Sharing Statement Module

Plan to Share IPD

Undecided

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