Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Femoral Nerve Block plus Sciatic Nerve Block | Active Comparator | After induction of general anesthesia, participants receive an ultrasound-guided single-shot femoral nerve block with 15 milliliters of 0.25% bupivacaine and an ultrasound-guided single-shot popliteal sciatic nerve block with 15 milliliters of 0.25% bupivacaine. Postoperative multimodal analgesia includes intravenous acetaminophen and ketorolac. Rescue analgesia is intravenous nalbuphine 5 milligrams when the Numeric Rating Scale pain score is 3 or higher, up to 20 milligrams per day. |
|
| Para-sartorial Compartments Block | Experimental | After induction of general anesthesia, participants receive an ultrasound-guided single-shot para-sartorial compartments block using a single needle entry point with three injections of 0.25% bupivacaine: 10 milliliters inside the femoral triangle with periarterial and subsartorial spread, 10 milliliters in the subsartorial plane at the apex of the femoral triangle between sartorius and vastus medialis muscles, and 10 milliliters in the suprasartorial compartment at the level of the intermediate femoral cutaneous nerve (total 30 milliliters). Postoperative multimodal analgesia includes intravenous acetaminophen and ketorolac. Rescue analgesia is intravenous nalbuphine 5 milligrams when the Numeric Rating Scale pain score is 3 or higher, up to 20 milligrams per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound-Guided Femoral Nerve Block plus Sciatic Nerve Block | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Rescue Analgesia Requirement (Nalbuphine) | 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. | First 24 hours after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain Intensity (Numeric Rating Scale) | Pain intensity measured using the Numeric Rating Scale (0 = no pain, 10 = worst possible pain). | 30 minutes after admission to the post-anesthesia care unit, and 3 hours, 6 hours, 12 hours, and 24 hours after surgery. |
| Motor Block Assessment (Modified Bromage Scale) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University Hospitals | Cairo | Cairo Governorate | 11511 | Egypt |
De-identified individual participant data underlying the primary and secondary outcomes (including total nalbuphine rescue dose, Numeric Rating Scale pain scores, modified Bromage motor scores, procedure time, block duration, and adverse events) will be made available to qualified researchers upon reasonable request.
Data will be available beginning 6 months after publication of the primary manuscript and will remain available for 5 years.
Requests should include a brief proposal and analysis plan. Access will be provided after review and approval by the study investigators and completion of a data use agreement. Data will be shared in a de-identified format.
Not provided
Not provided
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.
Not provided
Not provided
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.
|
| Ultrasound-Guided Para-sartorial Compartments Block | Procedure | 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). |
|
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). |
| 2 hours, 4 hours, 6 hours, 12 hours, 18 hours, and 24 hours after surgery. |
| Block Performance Time | Time from ultrasound scanning start to completion of local anesthetic injection (in minutes). | During block performance immediately after induction of general anesthesia. |
| Block Duration | Duration of sensory and motor effects of the nerve block as assessed clinically (in hours). | Up to 24 hours after surgery. |
| Postoperative Nausea | Presence of postoperative nausea during the first postoperative day. | First 24 hours after surgery. |
| Postoperative Vomiting | Presence of postoperative vomiting during the first postoperative day. | First 24 hours after surgery. |
| Sedation (Richmond Agitation-Sedation Scale) | Richmond Agitation-Sedation Scale score ranging from +4 (combative) to -5 (unarousable); 0 indicates alert and calm. | First 24 hours after surgery. |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010149 | Pain, Postoperative |
| D001733 | Bites and Stings |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D014947 | Wounds and Injuries |
Not provided
Not provided