Clinical trial NCT02444559: Does Perineural Clonidine Prolong Duration of a Nerve Block?
Official title: Does Perineural Clonidine Prolong the Duration of an Adductor Canal Block When Controlling for a Systemic Effect? - A Randomised Paired Trial in Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy
Keywords: Volunteers
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2015-05-14
Enrollment: 21
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this trial is to investigate if clonidine prolongs the duration of an adductor canal block. By using healthy volunteers the investigators can perform a bilateral adductor canal block and thereby control for a systemic effect to clarify if the effect is actually peripheral or systemic. The investigators hypothesis is that clonidine/dexmedetomidine as an adjunct to a local anaesthetic prolongs the duration of a peripheral nerve block by a peripheral mechanism.

Detailed description: Background:

Efficient pain management promoting mobilization and convalescence is essential in an ideal perioperative course. Regional nerve blocks are a central element in postoperative regimes for many patients and it is therefore important that these nerve blocks are both long lasting and efficient. This trial will investigate whether it is possible to optimize the postoperative pain management when adding clonidine to the local anaesthetic ropivacaine in peripheral nerve blocks.

The prolonging effect of using clonidine as adjuncts in peripheral nerve blocks have been investigated in several studies. However, it remains uncertain whether the effect is mediated by a systemic-, a peripheral- or a combined systemic/peripheral mechanism. In this trial the adjuvating effect of clonidine will be investigated using the adductor canal block. This is a nerve block that besides being efficient as pain treatment after knee surgery, is primarily sensory, and therefore augments mobilization after total knee arthroplasty.

Method:

On the trial day the volunteers will receive bilateral adductor canal blocks. In one thigh they will receive the local anaesthetic ropivacaine 20ml 5mg/ml and placebo (saline) and in the other thigh ropivacaine 20ml 5mg/ml and Clonidine 150μg. The allocation is blinded to volunteer and investigator.

The duration of the nerve block will be measured by five different tests: Temperature test, Pinprick, Pain during tonic heat stimulation, Warmth detection threshold and pain detection threshold. All tests are validated within pain research.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists class 1
* Body Mass Index 18-30

Exclusion Criteria:

* Allergy to study medication
* Earlier trauma or surgery to lower limb
* Diabetes Mellitus
* Alcohol or drug abuse
* Daily intake of opioids or steroids last 4 weeks
* Daily intake of any analgesics last 48 hours Heart block Sick sinus node.

Primary outcomes:
measure: Difference in duration of sensory block between clonidine and placebo assessed as cold sensation with an alcohol swab
timeFrame: 0-36 hours
Secondary outcomes:
measure: Difference between Clonidine and placebo in the duration of a sensory block assessed by pin-prick
timeFrame: 0-36 hours
measure: Difference between clonidine and placebo in the duration of a sensory block assessed as maximum pain during a tonic heat stimulation test
timeFrame: 0-36 hours
measure: Difference between clonidine and placebo in the duration of a sensory block assessed as warmth detection threshold
timeFrame: 0-36 hours
measure: Difference between clonidine and placebo in the duration of a sensory block assessed as heat pain detection threshold
timeFrame: 0-36 hour
measure: Difference in maximum pain scores between clonidine and placebo during block and after recovery of normal sensation.
timeFrame: 0-36 hours
Other outcomes:
Locations:
city: Koege
country: Denmark
facility: Department of Anesthesiology Koege Hospital
Study officials:
affiliation: Department of Anesthesiology Koege Hospital
name: Jakob H Andersen, MD
role: PRINCIPAL_INVESTIGATOR
References: