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Efficacy and Safety of Dexmedetomidine to Bupivacaine in Supraclavicular Brachial Plexus Block

K

Kafrelsheikh University

Status

Completed

Conditions

Supraclavicular Brachial Plexus Block
Bupivacaine
Dexmedetomidine

Treatments

Drug: bupivacaine only
Drug: bupivacaine and dexmedetomidine.
Drug: bupivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT06020781
KFSIRB200-51

Details and patient eligibility

About

The study aims to evaluate the analgesic efficacy and safety of addition of 1µg/kg dexmedetomidine to 20ml bupivacaine compared to 20ml and 30ml bupivacaine without additives in ultrasound-guided supraclavicular brachial plexus block for anesthesia.

Full description

Dexmedetomidine, a highly selective α2 adrenergic agonist, has been used as an adjuvant to local anesthetics. Various clinical trials performed have shown dexmedetomidine to be safe when used as an adjuvant to local anesthetic in subarachnoid, caudal, and epidural Different doses of dexmedetomidine are commonly used as an additive in Ultrasound-guided supraclavicular brachial plexus block, 1 μg/kg and 2 μg/kg in which a high dose of dexmedetomidine does not prolong the duration of analgesia, but it is associated with lower heart rate and blood pressure. Incidence of hypotension and bradycardia is also more. Hence, a lower dose of 1 μg/kg dexmedetomidine is a good balance between safety and efficacy

Enrollment

75 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • American Society of Anesthesiologist (ASA) grade I or II patients
  • both sexes
  • scheduled for elective upper limb surgery below mid-humerus level under Ultrasound -guided Supraclavicular brachial plexus block .

Exclusion criteria

  • with pre-existing peripheral neuropathy of upper limb.
  • Bleeding disorders.
  • Infection at injection site.
  • Untreated pneumothorax.
  • Patients on adrenoreceptor agonist or antagonist therapy.
  • History of severe cardiac,.respiratory, hepatic, or renal disease.
  • pregnancy and known hypersensitivity to the study drugs.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

75 participants in 3 patient groups

Bupivacaine and Dexmedetomidine
Experimental group
Description:
Patients will receive ultrasound-guided Supraclavicular brachial plexus block with 20 ml bupivacaine 0.5% + 1 μg/kg dexmedetomidine.
Treatment:
Drug: bupivacaine and dexmedetomidine.
20 ml Bupivacaine without additives
Active Comparator group
Description:
Patients will receive ultrasound-guided Supraclavicular brachial plexus block with 20 ml bupivacaine 0.5% without additives.
Treatment:
Drug: bupivacaine only
30 ml bupivacaine without additives
Active Comparator group
Description:
Patients will receive ultrasound-guided Supraclavicular brachial plexus block with 30 ml bupivacaine 0.5% without additives as a control group.
Treatment:
Drug: bupivacaine

Trial contacts and locations

1

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Central trial contact

Gamal H Shams, MD

Data sourced from clinicaltrials.gov

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