NCT02573909

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2015

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 12, 2015

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 16, 2023

Status Verified

March 1, 2023

Enrollment Period

9 years

First QC Date

October 8, 2015

Last Update Submit

March 14, 2023

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

Oxycodone intravenouslyDRUG

Oxycodone intravenously 0,1mg/kg

Also known as: oxycodoneIV
Oxycodone epidurally
Oxycodone epidurallyDRUG

Oxycodone 0,1 mg epidurally

Also known as: oxycodoneEpid
Oxycodone intravenously

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kuopio University Hospital

Kuopio, Northern Savonia, 70029, Finland

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Merja Kokki, PhD

    Kuopio University Hospital, Kuopio, Finland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
similar syringes equal amount of drug
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 8, 2015

First Posted

October 12, 2015

Study Start

January 1, 2015

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

March 16, 2023

Record last verified: 2023-03

Locations

FI(1)