Actively Recruiting

Phase Not Applicable
Age: 18Years - 84Years
All Genders
Healthy Volunteers
ID06488768

Duration of Peripheral Nerve Blocks in Opioid Tolerant Individuals - A Volunteer Blinded Matched Case-control Study

Led by Charlotte Runge · Updated on 2024-07-05

40

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are examining whether peripheral nerve blocks work differently in people who regularly use opioids compared to those who do not. Peripheral nerve blocks are used to relieve postoperative pain, but prior studies suggest opioid tolerance may reduce their effectiveness. The study aims to compare the onset time and duration of a radial nerve block between opioid-tolerant and opioid-naive individuals to better understand if opioid use affects nerve block duration. Participants will receive an ultrasound-guided radial nerve block using 10 mL of Lidocaine 2%. Twenty opioid-tolerant individuals, who use at least 60 mg of morphine equivalent daily, will be matched by age and sex with opioid-naive individuals who have not used opioids in the last 30 days. The study will measure how long the sensory and motor blocks last and how quickly they begin after the nerve block. During the study, researchers will test and record the onset and duration of sensory and motor blockades up to one hour after the nerve block. Ultrasound images will be stored for documentation. The main focus is the difference in sensory block duration between the two groups. Secondary measures include onset times and motor block duration. The study will provide insights into whether opioid tolerance affects nerve block duration and if special postoperative care is needed for opioid users.

CONDITIONS

Brief Title

Duration of Peripheral Nerve Blocks in Opioid Tolerant Individuals - A Volunteer Blinded Matched Case-control Study

Who Can Participate

Age: 18Years - 84Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years
  • ASA physical status 1 to 3
  • For opioid group: chronic pain lasting more than three months and daily use of over 60 mg morphine equivalent for more than 7 days
  • For opioid naive group: no opioid use within 30 days prior to participation
  • Legally competent and able to give informed consent
Not Eligible

You will not qualify if you...

  • Age over 84 years
  • Inability to cooperate with the study
  • Inability to understand or speak Danish
  • Allergy to lidocaine or preservatives used in the study
  • Alcohol or drug abuse other than opioids
  • Peripheral neuropathy in the non-dominant upper limb
  • Previous major surgery or pathology of the upper limb
  • Active infection at the injection site
  • Pregnancy at the time of the trial
  • Second or third degree atrioventricular heart block without pacemaker
  • Severe liver disease
  • Severe kidney disease with eGFR below 30 mL/min
  • Daily treatment with drugs related to local analgesics or class IB antiarrhythmics
  • Daily treatment with class III antiarrhythmics such as amiodarone

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to one hour after nerve block placement

Participants receive an ultrasound-guided radial nerve block using 10 mL of Lidocaine 2%.

1 treatment visit (in-person)

Trial Site Locations

Total: 1 location

1

Silkeborg Regional Hospital

Silkeborg, Denmark, 8600

Actively Recruiting

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Research Team

M

Mikkel SH Jensen, MD

C

Charlotte Runge, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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