Combined Intrathecal Dexmedetomidine and Adductor Canal Block for Analgesia After Total Knee Arthroplasty

NCT06837844 | Recruiting

• 1 other identifier: MKSU 50-1-7
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this work is to evaluate the effect of combined intrathecal dexmedetomidine and adductor canal block for analgesia after total knee arthroplasty (TKA).

Conditions

Intrathecal Dexmedetomidine; Adductor Canal Block; Analgesia; Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Total morphine consumption

  The patient will receive a 3mg bolus of morphine as a rescue analgesic if the visual analog scale (VAS) was greater than 3, and if the pain persisted for more than 30 mins, the injection was repeated until the VAS became below 4

  48 hours postoperatively

Secondary Outcomes (6)

• Time to the 1st rescue analgesia

  48 hours postoperatively

• Degree of pain

  48 hours postoperatively

• Heart rate

  In post-anesthesia care unit (PACU) (Up to 1 hour)

• Mean arterial pressure

  In post-anesthesia care unit (PACU) (Up to 1 hour)

• Degree of patient satisfaction

  48 hours postoperatively

Study Arms (3)

Group ITD

EXPERIMENTAL

Patients will receive 15mg in 3ml hyperbaric bupivacaine intrathecally with 5 μg in 0.5ml dexmedetomidine + adductor canal block using 20 ml saline 0.9% at the end of surgery

Drug: Intrathecal Dexmedetomidine

Group ACB

ACTIVE COMPARATOR

Patients will receive 15mg in 3ml hyperbaric bupivacaine intrathecally with 0.5ml saline 0.9% + adductor canal block using 20 ml bupivacaine 0.25% at the end of surgery.

Drug: Adductor Canal Block

Group ITD+ACB

EXPERIMENTAL

Patients will receive 15mg in 3ml hyperbaric bupivacaine intrathecally with 5 μg in 0.5ml dexmedetomidine + adductor canal block using 20 ml bupivacaine 0.25% at the end of surgery.

Drug: Intrathecal Dexmedetomidine + Adductor Canal Block

Interventions

Intrathecal Dexmedetomidine DRUG

Patients will receive 15mg in 3ml hyperbaric bupivacaine intrathecally with 5 μg in 0.5ml dexmedetomidine + adductor canal block using 20 ml saline 0.9% at the end of surgery

Group ITD

Adductor Canal Block DRUG

Patients will receive 15mg in 3ml hyperbaric bupivacaine intrathecally with 0.5ml saline 0.9% + adductor canal block using 20 ml bupivacaine 0.25% at the end of surgery.

Group ACB

Intrathecal Dexmedetomidine + Adductor Canal Block DRUG

Patients will receive 15mg in 3ml hyperbaric bupivacaine intrathecally with 5 μg in 0.5ml dexmedetomidine + adductor canal block using 20 ml bupivacaine 0.25% at the end of surgery.

Group ITD+ACB

Eligibility Criteria

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

You may qualify if:

• Age from 18 to 75 years.
• Both sexes.
• American Society of Anesthesiology (ASA) physical status I-II.
• Scheduled for total knee arthroplasty under spinal anesthesia.

You may not qualify if:

• Patients with neurological or intellectual disability.
• History of allergy to local anesthetics or dexmedetomidine .
• Infection at the injection site.
• Prolonged use of analgesic or sedative medications.
• Coagulation abnormalities.
• Pregnancy.
• Obesity \[body mass index (BMI) \> 30 kg/m2\].

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

RECRUITING

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sherif K Arafa, MD

CONTACT

00201005714014; Sherifhafez1980@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology, Surgical Intensive Care and Pain Management Department, Faculty of Medicine, KafrElsheikh University, KafrElsheikh, Egypt.

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 20, 2025
• Study Start: February 20, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)