Clinical trial NCT06488768: Duration of Peripheral Nerve Blocks in Opioid Tolerant Individuals - A Volunteer Blinded Matched Case-control Study
Official title: Duration of Peripheral Nerve Blocks in Opioid Tolerant Individuals - A Volunteer Blinded Matched Case-control Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nerve Block
Opioid Tolerance
Keywords: Nerve Block
Opioid tolerance
Radialis Nerve block
Lead sponsor: Regionshospitalet Silkeborg
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A volunteer blinded matched case-control study.
Primary purpose: TREATMENT

Brief summary: Do peripheral nerve blocks work shorter if you are on opioids?

Background:

Peripheral nerve blocks effectively alleviate postoperative pain. Animal studies and human research indicate that opioid tolerance results in reduced effectiveness of local analgesics. This applies to both central nerve blockade and infiltration anaesthesia. The impact on peripheral nerve block in humans has not been evaluated. The aim of the study is to assess the onset time and duration of a radial nerve block in opioid tolerant individuals compared to opioid naive individuals. We hypothesise that peripheral nerve blocks cause shorter sensory and motor block in opioid-tolerant compared to opioid-naive counterparts.

Methods:

Twenty opioid-tolerant individuals will be matched by sex and age with opioid-naïve counterparts. Participants will undergo an ultrasound-guided radial nerve block. The onset time and duration of motor and sensory blockade will be tested and measured. The primary outcome is difference in duration of sensory nerve blockade between the two groups. The secondary outcomes include the onset time of sensory blockade, onset time of motor blockade, and difference in duration of motor nerve blockade.

Perspectives:

The data from this study will provide evidence for the duration of peripheral nerve block in opioid tolerant individuals and support if a specific postoperative protocol for opioid tolerant individuals is needed or it should be of special attention.


Eligibility criteria: Inclusion criteria for opioid group

* Age \> 18 years old
* ASA 1-3
* Chronic pain, defined as persisting pain for more than three months
* Daily use of more than 60 mg of morphine equivalent in more than 7 days
* Legally competent and able to give informed consent

Inclusion criteria for the opioid naive control group

* Age \> 18 years old
* ASA 1-3
* No use of opioids within 30 days prior to participation
* Legally competent and able to give informed consent

Exclusion Criteria:

* Age \> 84 years old
* Volunteers who cannot cooperate with the study
* Volunteers who cannot understand or speak Danish
* Allergy to the lidocaine or the preservatives used in the study
* Alcohol or drug abuse other than opioids
* Peripheral neuropathy at the upper limb non-dominant arm
* Pathology or previous major surgery to the upper limb
* Active signs of infection in the cutaneous area of injection
* Pregnancy at the time of the trial
* Partial or complete 2nd or 3rd degree atrioventricular heart block without a pacemaker
* Severe liver disease
* Severe kidney disease and reduced kidney function (eGFR below 30 mL/min)
* Daily treatment with drugs that are structurally related to local analgesics or class IB antiarrhythmics, as the toxic effects are additive
* Daily treatment with class III antiarrhythmics e.g., amiodarone.

Primary outcomes:
measure: The difference in the duration of sensory block for a radial nerve block between opioid-tolerant and opioid-naive individuals.
timeFrame: Up to one hour after nerve block placement.
Secondary outcomes:
measure: The difference in the onset time of sensory block from a radial nerve block between opioid-tolerant and opioid-naive individuals.
timeFrame: Up to one hour after nerve block placement.
measure: The difference in the onset time of motor block from a radial nerve block between opioid-tolerant and opioid-naive individuals.
timeFrame: Up to one hour after nerve block placement.
measure: The difference in the duration of motor block for a radial nerve block between opioid-tolerant and opioid-naive individuals.
timeFrame: Up to one hour after nerve block placement.
Other outcomes:
Locations:
city: Silkeborg
country: Denmark
facility: Silkeborg Regional Hospital
Study officials:
References: