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

Not Applicable

Completed

• Conditions: Cancer Patients
• Interventions: Procedure: The local anesthetic injection

• Registration Number: NCT01704469
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2012-10
• Study First Submitted: 2012-10-08
• Study First Submitted QC: 2012-10-08
• Last Update Submitted: 2012-10-08
• Study First Posted: 2012-10-11
• Last Update Posted: 2012-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
The local anesthetic injection group	The local anesthetic injection	-

Primary Outcome Measures

Name	Time	Method
Post-injection pain intensity	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).

Trial Locations

Locations (1)

Severance hospital; 🇰🇷 Seoul, Korea, Republic of