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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01704469
Recruitment Status : Completed
First Posted : October 11, 2012
Last Update Posted : October 11, 2012
Information provided by (Responsible Party):
Yonsei University

Brief 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.

Condition or disease Intervention/treatment Phase
Cancer Patients Procedure: The local anesthetic injection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : March 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Arm Intervention/treatment
Experimental: The local anesthetic injection group Procedure: The local anesthetic injection

Primary Outcome Measures :
  1. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01704469

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Korea, Republic of
Severance hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
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Responsible Party: Yonsei University Identifier: NCT01704469    
Other Study ID Numbers: 4-2012-0066
First Posted: October 11, 2012    Key Record Dates
Last Update Posted: October 11, 2012
Last Verified: October 2012
Keywords provided by Yonsei University:
Opioid induced hyperalgesia
Additional relevant MeSH terms:
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Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents