Ultrasound-Guided PASC Block vs Femoral-Sciatic Nerve Block for Postoperative Analgesia After Total Knee Arthroplasty

NCT07320833 | Completed

• 1 other identifier: FMASU MD 29/2023
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis; Postoperative Pain; Total Knee Arthroplasty

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

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (7)

• 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.

• Motor Block Assessment (Modified Bromage Scale)

  2 hours, 4 hours, 6 hours, 12 hours, 18 hours, and 24 hours after surgery.

• Block Performance Time

  During block performance immediately after induction of general anesthesia.

• Block Duration

  Up to 24 hours after surgery.

• Postoperative Nausea

  First 24 hours after surgery.

Study Arms (2)

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.

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.

Procedure: Ultrasound-Guided Para-sartorial Compartments Block

Interventions

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.

Femoral Nerve Block plus Sciatic Nerve Block

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).

Para-sartorial Compartments Block

Eligibility Criteria

• Age: 60 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Cairo Governorate, 11511, Egypt

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain, Postoperative; Bites and Stings

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesia, Intensive Care and Pain Management

Model Details: 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.

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 6, 2026
• Study Start: February 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be available beginning 6 months after publication of the primary manuscript and will remain available for 5 years.
• Access Criteria: 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.

Locations

EG (1)