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Dexamethasone Versus Dexmedetomidine as Adjuvants for Nerve Blocks

U

University of Chile

Status

Completed

Conditions

Pain, Acute
Pain, Postoperative
Upper Extremity Injury

Treatments

Drug: Dexmedetomidine
Drug: Dexamethasone

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

When used as perineural (PN) adjuvants to local anesthetics (LAs), dexamethasone (DX) and dexmedetomidine (DXD) have been well documented to prolong the duration of peripheral nerve blocks. These drugs have important differences in terms of cost and safety profiles. This randomized controlled trial (RCT) will compare PN DX and PN DXD for ultrasound-guided infraclavicular brachial plexus blocks (ICBs).

Since analgesic and sensory duration can be influenced by factors different to block, motor block duration is the main outcome. The protocol is designed as an equivalency trial and hypothesize that both drugs result in similar durations. The equivalency margin is set at 3 hrs.

Enrollment

120 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • age between 18 and 75 years
  • American Society of Anesthesiologists classification 1-3
  • body mass index between 20 and 35

Exclusion criteria

  • adults who are unable to give their own consent
  • pre-existing neuropathy (assessed by history and physical examination)
  • coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
  • renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
  • hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
  • allergy to local anesthetics (LAs)
  • pregnancy
  • prior surgery in the infraclavicular region
  • chronic pain syndromes requiring opioid intake at home

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

120 participants in 2 patient groups

Perineural dexamethasone
Active Comparator group
Description:
addition of dexamethasone to local anesthetics in infraclavicular brachial plexus block
Treatment:
Drug: Dexamethasone
Perineural dexmedetomidine
Active Comparator group
Description:
addition of dexmedetomidine to local anesthetics in infraclavicular brachial plexus block
Treatment:
Drug: Dexmedetomidine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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