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

Not Applicable

Recruiting

• Conditions: Intrathecal Dexmedetomidine; Adductor Canal Block; Analgesia; Total Knee Arthroplasty
• Interventions: Drug: Intrathecal Dexmedetomidine; Drug: Adductor Canal Block; Drug: Intrathecal Dexmedetomidine + Adductor Canal Block

• Registration Number: NCT06837844
• Lead Sponsor: Kafrelsheikh University

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).

Detailed Description

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.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-13
• Study First Submitted QC: 2025-02-19
• Study Start: 2025-02-20
• Study First Posted: 2025-02-20
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-21
• Primary Completion: 2025-08-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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].

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group ITD	Intrathecal Dexmedetomidine	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 ACB	Adductor Canal Block	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 ITD+ACB	Intrathecal Dexmedetomidine + Adductor Canal Block	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 Outcome Measures

Name	Time	Method
Total morphine consumption	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 Outcome Measures

Name	Time	Method
Time to the 1st rescue analgesia	48 hours postoperatively	Time to the 1st rescue analgesia will be recorded from the end of surgery till the first dose of morphine administered.
Mean arterial pressure	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).
Incidence of adverse events	48 hours postoperatively	Incidence of adverse events such as bradycardia, hypotension, nausea, vomiting, respiratory depression, or any other complication will be recorded.
Degree of pain	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
Heart rate	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).
Degree of patient satisfaction	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)

Trial Locations

Locations (1)

Kafrelsheikh University; 🇪🇬 Kafr Ash Shaykh, Kafrelsheikh, Egypt