The Safety and Efficacy of Epidural Oxycodone

NCT ID: NCT02573909

Last Updated: 2023-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-01

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
similar syringes equal amount of drug

Study Groups

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Oxycodone intravenously

Oxycodone 0,1 mg/kg IV

Group Type EXPERIMENTAL

Oxycodone epidurally

Intervention Type DRUG

Oxycodone 0,1 mg epidurally

Oxycodone epidurally

Oxycodone 0,1 mg/kg epidurally

Group Type EXPERIMENTAL

Oxycodone intravenously

Intervention Type DRUG

Oxycodone intravenously 0,1mg/kg

Interventions

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Oxycodone intravenously

Oxycodone intravenously 0,1mg/kg

Intervention Type DRUG

Oxycodone epidurally

Oxycodone 0,1 mg epidurally

Intervention Type DRUG

Other Intervention Names

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oxycodoneIV oxycodoneEpid

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Admescope Ltd

INDUSTRY

Sponsor Role collaborator

Kuopio University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Merja Kokki

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Merja Kokki, PhD

Role: PRINCIPAL_INVESTIGATOR

Kuopio University Hospital, Kuopio, Finland

Locations

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Kuopio University Hospital

Kuopio, Northern Savonia, Finland

Site Status

Countries

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Finland

Other Identifiers

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KUH2014-004313-82

Identifier Type: -

Identifier Source: org_study_id

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