An interventional study of Intrathecal Dexmedetomidine and Adductor Canal Block in Intrathecal Dexmedetomidine, Adductor Canal Block and Analgesia, sponsored by Kafrelsheikh University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-02-21.
Sponsored by Kafrelsheikh University · Not applicable, Interventional, and Treatment
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).
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.
1,190 studies on the registry are indexed under Agnosia; 508 are open to participants now.
This study's planned enrollment of 75 is close to the median of 78 across 1,024 interventional studies indexed under Agnosia.
Browse Agnosia studies →Kafrelsheikh University is the lead sponsor of 285 studies on the registry; 110 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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
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
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
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
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.
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.
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
Time frame: 48 hours postoperatively
Time to the 1st rescue analgesia
Time to the 1st rescue analgesia will be recorded from the end of surgery till the first dose of morphine administered.
Time frame: 48 hours postoperatively
Degree of pain
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
Time frame: 48 hours postoperatively
Heart rate
Heart rate will be recorded every 5 minutes till the end of surgery and in post-anesthesia care unit (PACU).
Time frame: In post-anesthesia care unit (PACU) (Up to 1 hour)
Mean arterial pressure
Mean arterial pressure will be recorded every 5 minutes till the end of surgery and in post-anesthesia care unit (PACU).
Time frame: In post-anesthesia care unit (PACU) (Up to 1 hour)
Degree of patient satisfaction
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)
Time frame: 48 hours postoperatively
Incidence of adverse events
Incidence of adverse events such as bradycardia, hypotension, nausea, vomiting, respiratory depression, or any other complication will be recorded.
Time frame: 48 hours postoperatively
Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Supporting information: Study protocol
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Kafrelsheikh University