dexmed_ACB: Intravenous Versus Perineural Dexmedetomidine as Adjuvant in Adductor Canal Block for Total Knee Arthroplasty
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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]
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
- 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
- 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
- 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)
Eligibility Criteria
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:
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mansoura University Hospitals | Mansoura | Egypt |
Sponsors and Collaborators
- Mansoura University
Investigators
- Principal Investigator: Maha Abozeid, MD, Faculty of Medicine - Mansoura University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- dexmedetomidine