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

NCT01704469 | Completed

• 1 other identifier: 4-2012-0066
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Patients

Keywords

Opioid induced hyperalgesia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

The local anesthetic injection group

EXPERIMENTAL

Procedure: The local anesthetic injection

Interventions

The local anesthetic injection PROCEDURE

The local anesthetic injection group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance hospital

Seoul, Seoul, 120-752, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2012
• First Posted: October 11, 2012
• Study Start: March 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: October 11, 2012

Record last verified: 2012-10

Locations

KR (1)