NCT05566561

Brief Summary

Selective blockade of the saphenous nerve branches is among the regional anesthesia techniques in knee surgery. In this block, analgesia is provided without motor block and is an essential advantage in terms of early mobilization in the postoperative period. Blockage of motor branches causes a delay in mobilization and increases the risk of falling. The vastus medialis and its medical femoral cutaneous branch are rich in the femoral triangle. Effective postoperative analgesia is provided by a femoral triangle (triangle) blockade. The intermediate femoral cutaneous nerve courses over the sartorius muscle. Anatomically, the femoral triangle follows a separate path. When the femoral triangle and the blockade of the intermediate femoral cutaneous nerve are combined, it is called PSKB block. Parasartorial compartment block (PSKB); is based on the blockade of the branches of the saphenous nerve, the two largest sensory nerves from the femoral nerve to the knee, and is predicted to provide effective postoperative analgesia in knee arthroplasty.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 4, 2022

Completed
15 days until next milestone

Study Start

First participant enrolled

October 19, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2025

Completed
Last Updated

December 2, 2025

Status Verified

November 1, 2025

Enrollment Period

2.8 years

First QC Date

September 30, 2022

Last Update Submit

November 29, 2025

Conditions

Keywords

Knee SurgeryPostoperative pain managementPostoperative AnalgesiaParasartorial compartment block

Outcome Measures

Primary Outcomes (1)

  • Pain scores (Numerical Rating Scale-NRS)

    Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)

    Changes from baseline pain scores at postoperative 8th hour

Secondary Outcomes (2)

  • Rescue analgesia (Opioid-tramadol consumption)

    Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.

  • Adverse events will be recorded

    Postoperative 24 hours period

Study Arms (2)

Group PSCB = Parasartorial compartment block group

ACTIVE COMPARATOR

After placing the linear ultrasound probe in the middle of the anterior superior line to the patella and spina drug, the probe will be advanced cephalad to visualize the intermediate femoral cutaneous nerve over the satrorious. Then the block will be applied. Three injections will be made with a single needle entry in the same imaging. The procedure will be completed by applying the first injection to the femoral triangle (10 ml of local anesthetic solution), the second injection to the subsartorial region (10 ml of local anesthetic solution) lateral to the femoral artery, and the third injection to the suprasartorial region (10 ml of local anesthetic solution) (total 30 ml of 0.25% solution). concentration bupivacaine). The block location will be confirmed by injecting 2 ml of saline in every three injections.

Drug: Postoperative analgesia management

Group C = Control group

ACTIVE COMPARATOR

Wound infiltration will be applied by the surgical team

Drug: Postoperative analgesia management

Interventions

Intravenous 0.5 mg/kg tramadol and 400 mg ibuprofen will be administered to all patients 30 minutes before the end of the surgical procedure. In the postoperative period, patients will be administered ibuprofen iv 400 mg 3x1. Postoperative patient evaluation will be performed by another pain nurse who is unaware of the procedure. Patients in all groups will be attached to IV PCA containing 10 mcg/ml fentanyl, 10 mcg bolus without infusion dose, and 10 min lock time protocol. If the NRS score is ≥ 4, 0.5 mg kg-1 iv meperidine will be administered as a rescue analgesic.

Group C = Control groupGroup PSCB = Parasartorial compartment block group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with ASA classification I-III,
  • Aged 18-75 years
  • Who will be scheduled for knee surgery under spinal anesthesia.

You may not qualify if:

  • Patients who have a history of bleeding diathesis,
  • Take anticoagulant therapy,
  • History of chronic pain before surgery,
  • Multiple trauma,
  • Who cannot assess their pain,
  • Who have been operated under spinal anesthesia,
  • Who have an infection in the area and do not accept the procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University Hospital

Istanbul, Bagcilar, 34070, Turkey (Türkiye)

Location

Related Publications (3)

  • Pascarella G, Costa F, Del Buono R, Strumia A, Cataldo R, Agro F, Carassiti M. The para-sartorial compartments (PASC) block: a new approach to the femoral triangle block for complete analgesia of the anterior knee. Anaesth Rep. 2022 May 5;10(1):e12165. doi: 10.1002/anr3.12165. eCollection 2022 Jan-Jun. No abstract available.

    PMID: 35547556BACKGROUND
  • Martin R, Kirkham KR, Ngo THN, Gonvers E, Lambert J, Albrecht E. Combination of femoral triangle block and infiltration between the popliteal artery and the capsule of the posterior knee (iPACK) versus local infiltration analgesia for analgesia after anterior cruciate ligament reconstruction: a randomized controlled triple-blinded trial. Reg Anesth Pain Med. 2021 Sep;46(9):763-768. doi: 10.1136/rapm-2021-102631. Epub 2021 May 26.

    PMID: 34039734BACKGROUND
  • Stebler K, Martin R, Kirkham KR, Lambert J, De Sede A, Albrecht E. Adductor canal block versus local infiltration analgesia for postoperative pain after anterior cruciate ligament reconstruction: a single centre randomised controlled triple-blinded trial. Br J Anaesth. 2019 Aug;123(2):e343-e349. doi: 10.1016/j.bja.2019.04.053. Epub 2019 May 24.

    PMID: 31130273BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, KneeKnee Injuries

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesLeg InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The patient and the outcomes assessor who performs postoperative pain evaluation will not know the group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: There are two models for this study. Parasartorial compartment block (PSCB) group, and control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary researcher

Study Record Dates

First Submitted

September 30, 2022

First Posted

October 4, 2022

Study Start

October 19, 2022

Primary Completion

August 10, 2025

Study Completion

September 16, 2025

Last Updated

December 2, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

The investigators will not share IPD

Locations