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A Comparison of the Perception of a Needle Injection Pain Between Cancer Patients Receiving Opioid Therapy Versus Opioid-naive Patients

NCT ID: NCT01704469

Last Updated: 2012-10-11

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

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-09-30

Brief Summary

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Opioid-induced hyperalgesia (OIH) is most broadly defined as a state of nociceptive sensitization caused by exposure to opioids. In humans, the evidence of OIH is strong but conflicting. Previous clinical studies mostly used experimental or non-standardized surgical stimuli to assess OIH. We therefore sought to certify a presence of OIH using a standardized, clinical pain stimuli in cancer patients receiving opioid therapy and opioid-naive patients.

Detailed Description

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Conditions

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Cancer Patients

Keywords

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Opioid induced hyperalgesia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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The local anesthetic injection group

Group Type EXPERIMENTAL

The local anesthetic injection

Intervention Type PROCEDURE

Interventions

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The local anesthetic injection

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* age 20-80
* cancer patient
* patient whom receiving opioid treatment, any acute or chronic pain condition amenable to a diagnostic/therapeutic nerve block or neuromodulation,and a regular analgesic regimen.

Exclusion Criteria

* patient who has any change in opioid or other analgesic medications less than 14 days prior to the scheduled procedure
* an inability to understand English or adequately respond to the relevant questions
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Severance hospital

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2012-0066

Identifier Type: -

Identifier Source: org_study_id