- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01704469
A Comparison of the Perception of a Needle Injection Pain Between Cancer Patients Receiving Opioid Therapy Versus Opioid-naive Patients
October 8, 2012 updated by: Yonsei University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Seoul, Korea, Republic of, 120-752
- Severance Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: The local anesthetic injection group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-injection pain intensity
Time Frame: 1 min after lidocaine anesthetic injection
|
The local anesthetic injection before main procedure was performed by one pain physician using a 25-gauge needle and 1 ml of 1% lidocaine to raise a small skin wheel.
Before and immediately following the injection, patients were asked to rate injection-specific pain and unpleasantness intensity on a 0 to 10 numerical rating scale (NRS).
|
1 min after lidocaine anesthetic injection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (ACTUAL)
September 1, 2012
Study Completion (ACTUAL)
September 1, 2012
Study Registration Dates
First Submitted
October 8, 2012
First Submitted That Met QC Criteria
October 8, 2012
First Posted (ESTIMATE)
October 11, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
October 11, 2012
Last Update Submitted That Met QC Criteria
October 8, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4-2012-0066
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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