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Completed

NCT Number: NCT03940469

Dexmedetomidine Versus Dexamethasone With Levobupivacaine in Interscalene Block

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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ashraf Eskandr

Shibīn al Kawm, Monufia Governorate, 1234, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Saline

Drug

2 ml normal saline

Other names: normal saline

Dexamethasone Injection

Drug

8 mg dexamethasone

Other names: dexamethsone

Dexmedetomidine Hydrochloride

Drug

100 microgram dexmedetomidine

Other names: dexmedetomidine

Primary outcomes

  1. Changes in postoperative analgesia

    Time frame: During first 2 days after surgery

    Assessed by measuring severity of pain by visual analog score(score 0 to 10 cm with 0= no pain and 10=worst pain imaginable).

Secondary outcomes

  1. Postoperative analgesic requirement

    Time frame: During first 2 days after surgery

    Total amount of paracetamol required in mg

  2. Hemodynamic parameter

    Time frame: During first 2 days after surgery

    Heart rate

  3. Hemodynamic parameter

    Time frame: During first 2 days after surgery

    Mean arterial blood pressure

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Collaborators

  • Basma Abdelhamid Fathy
  • Mamdoh Elsayed Lotfy
  • Osama Abdallah Elsharkawy

Registry information

Official study title

Comparison Between Dexmedetomidine Versus Dexamethasone With Levobupivacaine in Ultrasound Guided Interscalene Block During Shoulder Arthroscopy: A Randomized Controlled Study

Acronym: IBBB

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
May 7, 2019
Registry last updated
May 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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