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

NCT ID: NCT04266145

Last Updated: 2022-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-29

Study Completion Date

2022-08-25

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Post Spinal Anesthesia Shivering

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The study anesthetic drugs both for adductor-canal-blockade and for intravenous infusion were prepared according to the group by an anesthetist who was not involved in its injection or the perioperative assessment

Study Groups

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intravenous dexmedetomidine

20 mL 0.25% levobupivacaine plus 1 mL normal saline will be administrated for adductor-canal-blockade while for intravenous solution; 0.5µg.kg-1 dexmedetomidine diluted in 20 mL normal saline will be prepared

Group Type ACTIVE_COMPARATOR

intravenous dexmedetomidine

Intervention Type 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-blockade dexmedetomidine

20 mL 0.25% levobupivacaine containing 1 mL of 0.5 mcg.kg-1 dexmedetomidine will be used for adductor-canal-blockade whereas, 20 mL 0.9% saline will be prepared for intravenous infusion

Group Type ACTIVE_COMPARATOR

adductor canal block dexmedetomidine

Intervention Type 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

Interventions

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intravenous dexmedetomidine

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

Intervention Type DRUG

adductor canal block dexmedetomidine

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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maha abou-zeid

lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maha Abozeid, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine - Mansoura University

Locations

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Mansoura University Hospitals

Al Mansurah, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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dexmedetomidine

Identifier Type: -

Identifier Source: org_study_id

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