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Dexmedetomidine Versus Dexamethasone With Levobupivacaine in Interscalene Block (IBBB)

M

Menoufia University

Status and phase

Completed
Phase 4

Conditions

Postoperative Complications
Postoperative Analgesia

Treatments

Drug: Dexmedetomidine Hydrochloride
Drug: Saline
Drug: Dexamethasone Injection

Study type

Interventional

Funder types

Other

Identifiers

NCT03940469
Interscalene Dexmedetomidine

Details and patient eligibility

About

The investigators compared between dexamethasone and dexmedetomidine when added to levobupivacaine in the quality and duration of ultrasound-guided interscalene block during shoulder arthroscopy.

Full description

Sixty patients were enrolled and divided into three groups 20 each, Group C received 35ml levobupivacaine+2ml normal saline under ultrasound guided interscalene block. Group H received 35ml levobupivacaine+8mg dexamethasone under ultrasound guided interscalene block. Group D received 35ml levobupivacaine+100umg dexmedetomidine+1ml normal saline. The primary outcome was the postoperative pain which was assessed by Visual analog score(VAS), the secondary outcomes were the onset and duration of sensory and motor block, the total amount of analgesic requirement, and blood cortisol level.

Enrollment

60 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Sixty healthy patients ASA I-II
  • Aged 18-60 years
  • Of both sexes
  • Scheduled for shoulder arthroscopy using ultrasound interscalene block were enrolled.

Exclusion criteria

  • Patients with a history of any allergic reactions to levobupivacaine, dexamethasone or α2 agonists
  • All patients with hypertension, cardiac, hepatic, renal or pulmonary diseases, - Patients who were under treatment by α2 agonist or antagonists
  • Pregnant women
  • Psychiatric patients
  • Patients with a previous history or clinical evidence of central or peripheral neurological disease
  • Coagulopathy or anticoagulant/antiaggregant therapy
  • Contralateral phrenic nerve paresis
  • Patients who have an infection at the site of the block.
  • Every patient who had an anatomical or vascular abnormality in the upper extremity were excluded from this study.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 3 patient groups, including a placebo group

Control group
Placebo Comparator group
Description:
received 35ml levobupivacaine+2ml normal saline under ultrasound guided interscalene block.
Treatment:
Drug: Saline
Dexamethasone group
Active Comparator group
Description:
received 35ml levobupivacaine+8mg dexamethasone
Treatment:
Drug: Dexamethasone Injection
Dexmeteomidine group
Active Comparator group
Description:
received 35ml levobupivacaine+100umg dexmedetomidine+1ml normal saline.
Treatment:
Drug: Dexmedetomidine Hydrochloride

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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