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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01704469
Other study ID # 4-2012-0066
Secondary ID
Status Completed
Phase N/A
First received October 8, 2012
Last updated October 8, 2012
Start date March 2012
Est. completion date September 2012

Study information

Verified date October 2012
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date September 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 80 Years
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Procedure:
The local anesthetic injection


Locations

Country Name City State
Korea, Republic of Severance hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Post-injection pain intensity 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 No
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