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

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.

Study Overview

• Status: Completed
• Conditions: Post Spinal Anesthesia Shivering
• Intervention / Treatment: Drug: intravenous dexmedetomidine; Drug: adductor canal block dexmedetomidine

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt
    • Mansoura University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: 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
Active Comparator: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of post-spinal anesthesia shivering	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)	up to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The analgesic duration	the time from adductor-canal-blockade injection till the first of postoperative dose of rescue analgesic	during the first postoperative 24 hours
total cumulative doses of rescue analgesic	given when visual analog scale for pain ≥ 40	after the first postoperative 24 hours
Modified Ramsay sedation scale	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	after 0.5 hour from adductor-canal-blockade then, 2, 4, 6, 8, 10, 12 and 24 hours postoperatively
non-invasive arterial blood pressure	mmHg	every 15 minutes after spinal anesthesia till the end of the surgery then at 0.5, 1, 3, 6, 12 hours postoperative
Heart rate	beat per minute	every 15 minutes after spinal anesthesia till the end of the surgery then at 0.5, 1, 3, 6, 12 hours postoperative
postoperative pain	visual analog scale for pain (0 mm= no pain, and 100 = the worst possible pain)	preoperative, 2, 4, 6, 8, 10, 12 and 24 hours postoperatively

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Maha Abozeid, MD, Faculty of Medicine - Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): February 29, 2020
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): August 25, 2022

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: February 11, 2020
• First Posted (Actual): February 12, 2020

Study Record Updates

• Last Update Posted (Actual): August 29, 2022
• Last Update Submitted That Met QC Criteria: August 26, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: dexmedetomidine-adductor canal block
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: Dexmedetomidine

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No