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Th Effects of a Drug Dexmedotemidine in Regional Anesthesia in Participants Undergoing Upper Limb Surgeries

Z

Zaher Nazzal

Status

Enrolling

Conditions

Supraclavicular Brachial Plexus Block

Treatments

Drug: Dexmedetomidine

Study type

Interventional

Funder types

Other

Identifiers

NCT04981951
F.Med.25th August/2020/10

Details and patient eligibility

About

In this study, we will assess the effect of combined Dexmedetomidine and Bupivacaine analgesia on the onset and duration of anesthesia in supraclavicular plexus block compared to Bupivacaine alone.

Full description

Participants who fulfill the inclusion criteria will be enrolled in this study to achieve sample size of 140 participants, 70 participants in each group.

Participants were blindly randomized into two groups: group A (Bupivacaine alone) and group B (Bupivacaine with Dexmedetomidine).

On the morning of the surgery day, and before performing the procedure on the targeted hand, a venous cannula 18gauze was secured on the opposite hand. Routine monitors like pulse oximetry, non-invasive blood pressure, and electrocardiogram were attached during the procedure.

Study medications were prepared for each group, which is Bupivacaine (30ml) only for group A and Bupivacaine (30 ml) with Dexmedetomidine (1 mcg /kg) for group B. Then, SCPB was done under ultrasound guidance which increases the safety due to improved monitoring of anatomy and needle placement. A needle was placed within the brachial plexus sheath posterior to the subclavian artery, and the local anesthetic injected to surround the trunks and divisions of the brachial plexus at this level.

Patients were evaluated for the onset of the sensory and motor block every 3 minutes after completion of injection till their onset, and, at 15, 30, 45, 60, 90, and 120 min; and then hourly (even after surgery), until they had resolved.

Enrollment

70 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Aged between 18-75 years.
  • Classified as grades 1 or 2 by the American Society of Anesthesiology Classification of .physical status.
  • Willing and able to sign a consent form.

Exclusion criteria

  • Patients under the following conditions will be excluded: Known hypersensitivity to Bupivacaine, Dexmedetomidine, and local anesthetics.
  • Uncontrolled diabetes mellitus.
  • Peripheral neuropathy.
  • SevereCoagulopathy.
  • Infection at the site of block.
  • Pregnancy.
  • Cardiac arrhythmias.
  • Prescription of beta blockers.
  • Psychological disorders.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

70 participants in 2 patient groups

Dexmedetomidine and Bupivacaine
Experimental group
Description:
Patients will be given Dexemtomidine ( the intervention) added to the Bupivacaine
Treatment:
Drug: Dexmedetomidine
Bupivacaine alone
No Intervention group
Description:
patients will be given Bupivacaine alone

Trial contacts and locations

1

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Central trial contact

Zaher Nazzal, MD

Data sourced from clinicaltrials.gov

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