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

Not Applicable

Completed

• Conditions: Post Spinal Anesthesia Shivering
• Interventions: Drug: intravenous dexmedetomidine; Drug: adductor canal block dexmedetomidine

• Registration Number: NCT04266145
• Lead Sponsor: Mansoura University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-02-10
• Study First Submitted QC: 2020-02-11
• Study First Posted: 2020-02-12
• Study Start: 2020-02-29
• Primary Completion: 2022-07-01
• Status Verified: 2022-08
• Study Completion: 2022-08-25
• Last Update Submitted: 2022-08-26
• Last Update Posted: 2022-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intravenous dexmedetomidine	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
adductor-canal-blockade dexmedetomidine	adductor canal block 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

Primary Outcome Measures

Name	Time	Method
incidence of post-spinal anesthesia shivering	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 Outcome Measures

Name	Time	Method
non-invasive arterial blood pressure	every 15 minutes after spinal anesthesia till the end of the surgery then at 0.5, 1, 3, 6, 12 hours postoperative	mmHg
total cumulative doses of rescue analgesic	after the first postoperative 24 hours	given when visual analog scale for pain ≥ 40
Modified Ramsay sedation scale	after 0.5 hour from adductor-canal-blockade then, 2, 4, 6, 8, 10, 12 and 24 hours postoperatively	1. Awake and alert, minimal or no cognitive impairment; 2. Awake but tranquil, purposeful responses to verbal commands at a conversational level; 3. Appears asleep, purposeful response to verbal commands at a conversational level; 4. Appears asleep, purposeful responses to commands but at a louder than conversational level, requiring light glabellar tap, or both; 5. Asleep, sluggish purposeful responses only to loud verbal commands, strong glabellar tap, or both; 6. Asleep, sluggish purposeful responses only to painful stimuli; 7. Asleep, reflex withdrawal to painful stimuli only; 8. Unresponsive to external stimuli, including pain
Heart rate	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
The analgesic duration	during the first postoperative 24 hours	the time from adductor-canal-blockade injection till the first of postoperative dose of rescue analgesic
postoperative pain	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)

Trial Locations

Locations (1)

Mansoura University Hospitals; 🇪🇬 Mansoura, Egypt