Clinical trial NCT04266145: Intravenous Versus Perineural Dexmedetomidine as Adjuvant in Adductor Canal Block for Total Knee Arthroplasty
Official title: Intravenous Versus Perineural Dexmedetomidine as Adjuvant in Adductor Canal Block for Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Spinal Anesthesia Shivering
Keywords: dexmedetomidine-adductor canal block
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-02-12
Enrollment: 56
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: incidence of post-spinal anesthesia shivering
timeFrame: up to 24 hours
Secondary outcomes:
measure: The analgesic duration
timeFrame: during the first postoperative 24 hours
measure: total cumulative doses of rescue analgesic
timeFrame: after the first postoperative 24 hours
measure: Modified Ramsay sedation scale
timeFrame: after 0.5 hour from adductor-canal-blockade then, 2, 4, 6, 8, 10, 12 and 24 hours postoperatively
measure: non-invasive arterial blood pressure
timeFrame: every 15 minutes after spinal anesthesia till the end of the surgery then at 0.5, 1, 3, 6, 12 hours postoperative
measure: Heart rate
timeFrame: every 15 minutes after spinal anesthesia till the end of the surgery then at 0.5, 1, 3, 6, 12 hours postoperative
measure: postoperative pain
timeFrame: preoperative, 2, 4, 6, 8, 10, 12 and 24 hours postoperatively
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospitals
Study officials:
affiliation: Faculty of Medicine - Mansoura University
name: Maha Abozeid, MD
role: PRINCIPAL_INVESTIGATOR
References: