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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04266145
Acronym
dexmed_ACB
Enrollment
56
Registered
2020-02-12
Start date
2020-02-29
Completion date
2022-08-25
Last updated
2022-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Spinal Anesthesia Shivering

Keywords

dexmedetomidine-adductor canal block

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.

Interventions

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

DRUGadductor 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

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

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

Eligibility

Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
incidence of post-spinal anesthesia shiveringup to 24 hours5-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

MeasureTime frameDescription
total cumulative doses of rescue analgesicafter the first postoperative 24 hoursgiven when visual analog scale for pain ≥ 40
Modified Ramsay sedation scaleafter 0.5 hour from adductor-canal-blockade then, 2, 4, 6, 8, 10, 12 and 24 hours postoperatively1. 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
The analgesic durationduring the first postoperative 24 hoursthe time from adductor-canal-blockade injection till the first of postoperative dose of rescue analgesic
Heart rateevery 15 minutes after spinal anesthesia till the end of the surgery then at 0.5, 1, 3, 6, 12 hours postoperativebeat per minute
postoperative painpreoperative, 2, 4, 6, 8, 10, 12 and 24 hours postoperativelyvisual analog scale for pain (0 mm= no pain, and 100 = the worst possible pain)
non-invasive arterial blood pressureevery 15 minutes after spinal anesthesia till the end of the surgery then at 0.5, 1, 3, 6, 12 hours postoperativemmHg

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026