Dexmedetomidine for Pain Relief

JA
Overseen ByJulián Aliste, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests dexmedetomidine, a sedative and pain relief medication, to determine the optimal dose for pain relief after upper arm surgery. Researchers are examining how long each dose can block pain signals when combined with standard local anesthetics. They expect the highest dose to provide the longest-lasting effect. Individuals undergoing surgery on their arm below the elbow, without certain medical conditions, might be suitable candidates for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that dexmedetomidine is generally safe when combined with local anesthetics for nerve blocks in the shoulder area. In past studies, most patients tolerated it well. However, about 7% experienced temporary bradycardia, or a slower heart rate. Importantly, no patients encountered breathing problems.

Some studies also found that dexmedetomidine might increase the risk of other side effects, though these were not detailed. Awareness of potential side effects is important. Overall, the treatment appears well-tolerated, but like any medication, it carries potential risks.12345

Why are researchers excited about this trial's treatments?

Dexmedetomidine is unique because it enhances pain relief when added to local anesthetics during infraclavicular brachial plexus blocks. While standard pain management options like opioids can have significant side effects and addiction potential, dexmedetomidine offers a non-opioid alternative. This treatment works by targeting specific receptors in the nervous system to provide sedation and analgesia without respiratory depression. Researchers are excited because it could potentially improve pain management with fewer side effects and lower risk of addiction.

What evidence suggests that this trial's treatments could be effective for pain relief?

Research shows that adding dexmedetomidine to local anesthetics enhances the effectiveness and duration of nerve blocks. Studies have found that combining dexmedetomidine with local anesthetics accelerates the onset and prolongs the duration of nerve blocks. Specifically, dexmedetomidine increases the duration of pain relief and reduces postoperative pain, making it a promising option for enhancing nerve blocks, such as those used in the shoulder area. In this trial, researchers are testing different doses of dexmedetomidine—1 mcg/kg, 0.67 mcg/kg, and 1.33 mcg/kg—to determine the optimal dose for pain relief.46789

Who Is on the Research Team?

JA

Julián Aliste, MD

Principal Investigator

McGill University Health Centre/Research Institute of the McGill University Health Centre

Are You a Good Fit for This Trial?

This trial is for individuals experiencing acute or postoperative pain, specifically those undergoing hand surgery that requires an infraclavicular block. Participants should be suitable for caudal epidural block therapy and not have anosognosia or other conditions that would exclude them from the study.

Inclusion Criteria

Body mass index between 18 and 35 kg/m2
I am between 18 and 75 years old.
I am having surgery on my arm at or below the elbow.
See 1 more

Exclusion Criteria

Breastfeeding
Allergy or contraindication to dexmedetomidine
Allergy to LA
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day
1 visit (in-person)

Preoperative Preparation

Preparation and randomization of patients for the infraclavicular brachial plexus block

1 day
1 visit (in-person)

Treatment

Administration of the infraclavicular brachial plexus block with different doses of dexmedetomidine

1 day
1 visit (in-person)

Immediate Postoperative Monitoring

Monitoring of motor and sensory block duration and other immediate postoperative outcomes

2 hours
Continuous monitoring (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including motor function return and any side effects

7 days
1 visit (in-person), phone follow-up

What Are the Treatments Tested in This Trial?

Interventions

  • Dexmedetomidine
Trial Overview The study tests three doses of dexmedetomidine (0.67 mcg/kg, 1 mcg/kg, and 1.33 mcg/kg) used with local anesthetics in ultrasound-guided infraclavicular blocks to determine which dose provides the longest motor block duration after hand surgery.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: 1.33 mcg/kgExperimental Treatment1 Intervention
Group II: 1 mcg/kgExperimental Treatment1 Intervention
Group III: 0.67 mcg/kgExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

McGill University Health Centre/Research Institute of the McGill University Health Centre

Lead Sponsor

Trials
476
Recruited
170,000+

Citations

A Comprehensive Review and Update of the Use ...Dexmedetomidine is an effective additive for nerve blockade in multiple locations and it may inclusively decrease the risk of nerve injury.
Evaluation of dexmedetomidine as an adjuvant to low ...Dexmedetomidine (DEX) can be used with local anesthetics (LAs) to enhance the efficiency of a peripheral nerve block.
Investigating the Efficacy of Dexmedetomidine as an ...Conclusions Dexmedetomidine has the ability to hasten the onset and prolong the duration of blockade when used as an adjuvant to local anesthesia for brachial ...
Dexmedetomidine as an adjuvant to local anesthetics in...One recent meta-analysis concluded that DEX as neuraxial adjuvant decreased postoperative pain intensity with 24 hours, prolonged analgesic duration by ...
Effects of Dexmedetomidine Versus Ketorolac as Local ...In this study we compared dexmedetomidine and ketorolac effects as local anesthetic adjuvants upon the onset and duration of sensory and motor ...
The effect and safety of dexmedetomidine added to ...The aim of this meta-analysis was to investigate the effect and safety of dexmedetomidine added to ropivacaine in brachial plexus block (BPB).
Study Details | Dexmedetomidine and Dexamethasone ...The aim of this study was to investigate the effect of dexmedetomidine and dexamethasone added during USG-guided infraclavicular block on block onset time, ...
Adverse event reporting in ultrasound-guided brachial ...Interscalene blocks accounted for 58 % of all reported adverse events, with hemidiaphragmatic paresis and Horner's syndrome being the most reported outcomes.
Facilitatory effects of perineural dexmedetomidine on ...Dexmedetomidine produced reversible bradycardia in 7% of BP block patients, but no effect on the incidence of hypotension. No patients experienced respiratory ...
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