Knee Osteoarthritis, Postoperative Pain, Total Knee Arthroplasty
Conditions
Keywords
Total knee arthroplasty (TKA), Total knee replacement (TKR), Para-sartorial compartments (PASC) block, Femoral nerve block, Sciatic nerve block, Ultrasound-guided nerve block, Regional anesthesia, Multimodal analgesia, Nalbuphine rescue analgesia, Numeric Rating Scale (NRS), Modified Bromage scale
Brief summary
This randomized, double-blind comparative study evaluates postoperative analgesic efficacy and motor effects of ultrasound-guided para-sartorial compartments (PASC) block versus ultrasound-guided combined femoral-sciatic nerve block in patients undergoing total knee arthroplasty. The primary endpoint is total nalbuphine rescue analgesia consumption in the first 24 postoperative hours. Secondary endpoints include pain scores (NRS), motor function using a modified Bromage scale, block performance characteristics, and complications.
Interventions
PROCEDUREUltrasound-Guided Femoral Nerve Block plus Sciatic Nerve Block
Single-shot ultrasound-guided femoral nerve block (15 milliliters of 0.25% bupivacaine) plus single-shot ultrasound-guided popliteal sciatic nerve block (15 milliliters of 0.25% bupivacaine), performed after induction of general anesthesia using sterile technique.
PROCEDUREUltrasound-Guided Para-sartorial Compartments Block
Single-shot ultrasound-guided para-sartorial compartments block performed after induction of general anesthesia using a single needle entry point and three injections of 0.25% bupivacaine: 10 milliliters in the femoral triangle with periarterial and subsartorial spread, 10 milliliters in the subsartorial plane at the apex of the femoral triangle, and 10 milliliters in the suprasartorial compartment at the level of the intermediate femoral cutaneous nerve (total 30 milliliters).
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Participants are unaware of group assignment. Outcome data are collected by an anesthesiologist blinded to the performed block technique. The anesthesiologist performing the block is not involved in postoperative assessments.
Intervention model description
Randomized, double-blind, two-arm parallel-group trial comparing ultrasound-guided PASC block versus combined ultrasound-guided femoral-sciatic nerve block for postoperative analgesia and motor function after total knee arthroplasty.
Eligibility
Sex/Gender
ALL
Age
60 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age 60 to 70 years * Scheduled for elective total knee arthroplasty under general anesthesia * American Society of Anesthesiologists physical status class I or II * Provided written informed consent
Exclusion criteria
* American Society of Anesthesiologists physical status class III or IV * Pre-existing neurological abnormality of the lower extremity * Infection near the planned block site * History of psychiatric illness * History of drug abuse * Known allergy to local anesthetics or any study medications (bupivacaine, acetaminophen, ketorolac, nalbuphine)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Rescue Analgesia Requirement (Nalbuphine) | First 24 hours after surgery. | Total dose of intravenous nalbuphine (in milligrams) administered as rescue analgesia when the Numeric Rating Scale pain score is 3 or higher, with a maximum daily dose of 20 milligrams. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Motor Block Assessment (Modified Bromage Scale) | 2 hours, 4 hours, 6 hours, 12 hours, 18 hours, and 24 hours after surgery. | Motor function assessed using the modified Bromage scale: 1 = complete block (unable to move knee or feet), 2 = almost complete (able to move feet only), 3 = partial (just able to move knees), 4 = none (full flexion of knees and feet). |
| Block Performance Time | During block performance immediately after induction of general anesthesia. | Time from ultrasound scanning start to completion of local anesthetic injection (in minutes). |
| Block Duration | Up to 24 hours after surgery. | Duration of sensory and motor effects of the nerve block as assessed clinically (in hours). |
| Postoperative Pain Intensity (Numeric Rating Scale) | 30 minutes after admission to the post-anesthesia care unit, and 3 hours, 6 hours, 12 hours, and 24 hours after surgery. | Pain intensity measured using the Numeric Rating Scale (0 = no pain, 10 = worst possible pain). |
| Postoperative Vomiting | First 24 hours after surgery. | Presence of postoperative vomiting during the first postoperative day. |
| Sedation (Richmond Agitation-Sedation Scale) | First 24 hours after surgery. | Richmond Agitation-Sedation Scale score ranging from +4 (combative) to -5 (unarousable); 0 indicates alert and calm. |
| Postoperative Nausea | First 24 hours after surgery. | Presence of postoperative nausea during the first postoperative day. |
Countries
Egypt
Outcome results
None listed