Knee OsteoarthritisNCT07320833
Ultrasound-Guided PASC Block vs Femoral-Sciatic Nerve Block for Postoperative Analgesia After Total Knee Arthroplasty
A study testing Ultrasound-Guided Femoral Nerve Block plus Sciatic Nerve Block and Ultrasound-Guided Para-sartorial Compartments Block in people with Knee Osteoarthritis and Postoperative Pain, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 70 years
- Conditions the study is for
- Knee Osteoarthritis, Postoperative Pain, Total Knee Arthroplasty
- What is being tested?
- Ultrasound-Guided Femoral Nerve Block plus Sciatic Nerve Block and Ultrasound-Guided Para-sartorial Compartments Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Analgesic Efficacy of Ultrasound Guided Para-sartorial Compartments (PASC) Block Versus Combined Femoral-Sciatic Nerve Block in Patients Undergoing Total Knee Arthroplasty: A Double-Blind Randomized Comparative Study
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.
- Being tested
- Ultrasound-Guided Femoral Nerve Block plus Sciatic Nerve Block, Ultrasound-Guided Para-sartorial Compartments Block
- 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
- Medical subject headings
- Osteoarthritis, Knee, Pain, Postoperative, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Femoral Nerve Block plus Sciatic Nerve BlockProcedure or surgery
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.
Ultrasound-Guided Para-sartorial Compartments BlockProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Ultrasound-Guided Femoral Nerve Block plus Sciatic Nerve Block |
| 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. Receives: Procedure: Ultrasound-Guided Para-sartorial Compartments Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First 24 hours after surgery.
Secondary outcomes (7)
Postoperative Pain Intensity (Numeric Rating Scale)
Pain intensity measured using the Numeric Rating Scale (0 = no pain, 10 = worst possible pain).
Measured: 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)
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).
Measured: 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).
Measured: 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).
Measured: Up to 24 hours after surgery.
Postoperative Nausea
Presence of postoperative nausea during the first postoperative day.
Measured: First 24 hours after surgery.
Postoperative Vomiting
Presence of postoperative vomiting during the first postoperative day.
Measured: 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.
Measured: First 24 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start1 Feb 2023
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Mohammed Elsayed Seif, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07320833
- Sponsor's protocol ID
- FMASU MD 29/2023
- Status last verified
- Dec 2025
- First submitted
- 22 Dec 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesic Efficacy of Ultrasound Guided Para-sartorial Compartments (PASC) Block Versus Combined Femoral-Sciatic Nerve Block in Patients Undergoing Total Knee Arthroplasty: A Double-Blind Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT07320833
- Acronym / sponsor ID
- FMASU MD 29/2023
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Femoral Nerve Block plus Sciatic Nerve Block | Active comparator | Procedure: Ultrasound-Guided Femoral Nerve Block plus Sciatic Nerve BlockAfter 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 | Procedure: Ultrasound-Guided Para-sartorial Compartments BlockAfter 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. |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-Guided Femoral Nerve Block plus Sciatic Nerve BlockSingle-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. | Procedure or surgery | Femoral Nerve Block plus Sciatic Nerve Block |
| Ultrasound-Guided Para-sartorial Compartments BlockSingle-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). | Procedure or surgery | Para-sartorial Compartments Block |
Primary outcome
Total Rescue Analgesia Requirement (Nalbuphine)
Time frame: 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.
7 secondary outcomes
Postoperative Pain Intensity (Numeric Rating Scale)
Time frame: 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)
Time frame: 2 hours, 4 hours, 6 hours, 12 hours, 18 hours, and 24 hours after surgery.
Block Performance Time
Time frame: During block performance immediately after induction of general anesthesia.
Block Duration
Time frame: Up to 24 hours after surgery.
Postoperative Nausea
Time frame: First 24 hours after surgery.
Postoperative Vomiting
Time frame: First 24 hours after surgery.
Sedation (Richmond Agitation-Sedation Scale)
Time frame: First 24 hours after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-Guided Femoral Nerve Block plus Sciatic Nerve Block and Ultrasound-Guided Para-sartorial Compartments Block in people with Knee Osteoarthritis and Postoperative Pain, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Rescue Analgesia Requirement (Nalbuphine) (time frame: First 24 hours after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.