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NCT Number: NCT06837844

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

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).

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Key information

Conditions

Intrathecal Dexmedetomidine Adductor Canal Block Agnosia Analgesia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Total Knee Arthroplasty

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

Location status: Recruiting

Location contact

Sherif K Arafa, MD

CONTACT

[email protected]

00201005714014

About this study

Effective postoperative pain management is essential for improving patient outcomes following knee surgery, facilitating early mobilization, and reducing the risk of complications.

The adductor canal block (ACB) is a nerve block of Hunters canal, which includes the saphenous and vastus medialis nerves. Additionally, other sensory nerves, such as the femoral nerve, medial cutaneous nerve, and both the anterior branch and terminal end of the posterior branch of the obturator nerve to some extent as it enters the distal part of the canal are blocked by the ACB.

Dexmedetomidine (DXM) a highly selective α2 adrenergic agonist with sedative, anxiolytic, analgesic, sympatholytic and antihypertensive effects.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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].

Treatment and study plan

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

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.

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.

Primary outcomes

  1. Total morphine consumption

    Time frame: 48 hours postoperatively

    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

Secondary outcomes

  1. Time to the 1st rescue analgesia

    Time frame: 48 hours postoperatively

    Time to the 1st rescue analgesia will be recorded from the end of surgery till the first dose of morphine administered.

  2. Degree of pain

    Time frame: 48 hours postoperatively

    Each patient will be instructed about postoperative pain assessment with the visual analog scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS will be assessed at 0, 4, 8, 12, 18, 24, 36 and 48 h postoperatively

  3. Heart rate

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

    Heart rate will be recorded every 5 minutes till the end of surgery and in post-anesthesia care unit (PACU).

  4. Mean arterial pressure

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

    Mean arterial pressure will be recorded every 5 minutes till the end of surgery and in post-anesthesia care unit (PACU).

  5. Degree of patient satisfaction

    Time frame: 48 hours postoperatively

    Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied)

  6. Incidence of adverse events

    Time frame: 48 hours postoperatively

    Incidence of adverse events such as bradycardia, hypotension, nausea, vomiting, respiratory depression, or any other complication will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Sherif K Arafa, MD

CONTACT

[email protected]

00201005714014

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study title

Combined Intrathecal Dexmedetomidine and Adductor Canal Block for Analgesia After Total Knee Arthroplasty: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 20, 2025
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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