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Completed

NCT Number: NCT04266145

Intravenous Versus Perineural Dexmedetomidine as Adjuvant in Adductor Canal Block for Total Knee Arthroplasty

Shivering increases the cardiac and systemic energy expenditure, oxygen consumption and carbon dioxide production. Definitive prevention and treatment of shivering is necessary to decrease the related complications and increase post-anesthetic comfort.

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Key information

Conditions

Post Spinal Anesthesia Shivering

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University Hospitals

Al Mansurah, Egypt

About this study

Dexmedetomidine a highly selective α2 adrenergic agonist used effectively as a safe analgesic via different routes and mechanisms, including intravenous (i.v.), neuraxial and perineural routes. Dexmedetomidine has been used for prevent shivering but, the results of its efficacy is still controversy.

No studies to date have investigated the best administration route of dexmedetomidine to dominantly prevent the occurrence of shivering after spinal anesthesia or associated with the least grade.

This prospective, randomized, double blinded study was designed to investigate the best administrative route of dexmedetomidine firstly, as a preventive of neuraxial shivering and secondly as adjunctive analgesic.

The incidence of post-spinal anesthesia shivering was the primary outcome. Perioperative hemodynamics, postoperative pain scores during rest and at 45-degree flexion of the knee, the analgesic duration, the first postoperative day analgesic consumption, the sedation score and early ambulation ability were the secondary outcomes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • adult patients
  • both genders
  • American Society of Anesthesiologists physical status I and II
  • scheduled for unilateral primary TKA under spinal anesthesia

Exclusion criteria

  • chronic opioid use
  • known allergy to the used drugs
  • any contraindications to regional anesthesia like; patient refusal, coagulopathy, neuropathy or infection at the injection site

Treatment and study plan

Intravenous dexmedetomidine

Drug

adductor-canal-blockade with 20 mL 0.25% levobupivacaine plus 1 mL normal saline while, the intravenous solution; consists of 0.5µg.kg-1 dexmedetomidine diluted in 20 mL normal saline

adductor canal block dexmedetomidine

Drug

adductor-canal-blockade with 20 mL 0.25% levobupivacaine plus 1 mL of 0.5µg.kg-1 dexmedetomidineline while, the intravenous solution;consists of 20 mL normal saline

Primary outcomes

  1. incidence of post-spinal anesthesia shivering

    Time frame: up to 24 hours

    5-point scale (0= no shivering, 1 =piloerection or peripheral vasoconstriction but no visible shivering; 2 =muscular activity in only one muscle group; 3 =muscular activity in more than one muscle group but not generalized and 4 = shivering involving the whole body)

Secondary outcomes

  1. The analgesic duration

    Time frame: during the first postoperative 24 hours

    the time from adductor-canal-blockade injection till the first of postoperative dose of rescue analgesic

  2. total cumulative doses of rescue analgesic

    Time frame: after the first postoperative 24 hours

    given when visual analog scale for pain ≥ 40

  3. Modified Ramsay sedation scale

    Time frame: after 0.5 hour from adductor-canal-blockade then, 2, 4, 6, 8, 10, 12 and 24 hours postoperatively

    • Awake and alert, minimal or no cognitive impairment
    • Awake but tranquil, purposeful responses to verbal commands at a conversational level
    • Appears asleep, purposeful response to verbal commands at a conversational level
    • Appears asleep, purposeful responses to commands but at a louder than conversational level, requiring light glabellar tap, or both
    • Asleep, sluggish purposeful responses only to loud verbal commands, strong glabellar tap, or both
    • Asleep, sluggish purposeful responses only to painful stimuli
    • Asleep, reflex withdrawal to painful stimuli only
    • Unresponsive to external stimuli, including pain

  4. non-invasive arterial blood pressure

    Time frame: every 15 minutes after spinal anesthesia till the end of the surgery then at 0.5, 1, 3, 6, 12 hours postoperative

    mmHg

  5. Heart rate

    Time frame: every 15 minutes after spinal anesthesia till the end of the surgery then at 0.5, 1, 3, 6, 12 hours postoperative

    beat per minute

  6. postoperative pain

    Time frame: preoperative, 2, 4, 6, 8, 10, 12 and 24 hours postoperatively

    visual analog scale for pain (0 mm= no pain, and 100 = the worst possible pain)

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Acronym: dexmed_ACB

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 12, 2020
Registry last updated
Aug 29, 2022

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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