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

NCT04266145 | Completed

• 1 other identifier: dexmedetomidine
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Spinal Anesthesia Shivering

Keywords

dexmedetomidine-adductor canal block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• The analgesic duration

  during the first postoperative 24 hours

• total cumulative doses of rescue analgesic

  after the first postoperative 24 hours

• Modified Ramsay sedation scale

  after 0.5 hour from adductor-canal-blockade then, 2, 4, 6, 8, 10, 12 and 24 hours postoperatively

• 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

• Heart rate

  every 15 minutes after spinal anesthesia till the end of the surgery then at 0.5, 1, 3, 6, 12 hours postoperative

Study Arms (2)

intravenous dexmedetomidine

ACTIVE COMPARATOR

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 dexmedetomidine

ACTIVE COMPARATOR

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

Interventions

intravenous dexmedetomidine DRUG

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

intravenous dexmedetomidine

adductor canal block dexmedetomidine DRUG

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

adductor-canal-blockade dexmedetomidine

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University Hospitals

Al Mansurah, Egypt

Location

Study Officials

• Maha Abozeid, MD

  Faculty of Medicine - Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 12, 2020
• Study Start: February 29, 2020
• Primary Completion: July 1, 2022
• Study Completion: August 25, 2022
• Last Updated: August 29, 2022

Record last verified: 2022-08

Locations

EG (1)