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Clinical Trials/NCT07320833
NCT07320833
Completed
Not Applicable

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

Ain Shams University1 site in 1 country62 target enrollmentStarted: February 1, 2023Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
62
Locations
1
Primary Endpoint
Total Rescue Analgesia Requirement (Nalbuphine)

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, 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.

Eligibility Criteria

Ages
60 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts 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)

Arms & Interventions

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.

Intervention: Ultrasound-Guided Femoral Nerve Block plus Sciatic Nerve Block (Procedure)

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.

Intervention: Ultrasound-Guided Para-sartorial Compartments Block (Procedure)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Block Performance Time(During block performance immediately after induction of general anesthesia.)
  • Block Duration(Up to 24 hours after surgery.)
  • 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.)
  • Postoperative Nausea(First 24 hours after surgery.)
  • Postoperative Vomiting(First 24 hours after surgery.)
  • Sedation (Richmond Agitation-Sedation Scale)(First 24 hours after surgery.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mahmoud Mohammed Elsayed Seif

Resident of Anesthesia, Intensive Care and Pain Management

Ain Shams University

Study Sites (1)

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