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

Post Spinal Anesthesia Shivering Clinical Trial

— dexmed_ACB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04266145
• Other study ID #: dexmedetomidine
• Status: Completed
• Phase: N/A
• Start date: February 29, 2020
• Est. completion date: August 25, 2022

Study information

• Verified date: August 2022
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: August 25, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Post Spinal Anesthesia Shivering

Intervention

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
• 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

Locations

Country	Name	City	State
Egypt	Mansoura University Hospitals	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	total cumulative doses of rescue analgesic	given when visual analog scale for pain = 40	after the first postoperative 24 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	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