search
Back to results

Para-sartorial Compartment Block in Knee Surgery

Primary Purpose

Knee Osteoarthritis, Knee Injuries, Knee Disease

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Postoperative analgesia management
Sponsored by
Medipol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee Surgery, Postoperative pain management, Postoperative Analgesia, Parasartorial compartment block

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Istanbul Medipol University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group PSCB = Parasartorial compartment block group

Group C = Control group

Arm Description

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.

Wound infiltration will be applied by the surgical team

Outcomes

Primary Outcome Measures

Opioid consumption
The fentanyl consumption on PCA device will be evaluated

Secondary Outcome Measures

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)
Adverse events will be recorded
Adverse events; nausea, vomiting, itching

Full Information

First Posted
September 30, 2022
Last Updated
June 26, 2023
Sponsor
Medipol University
search

1. Study Identification

Unique Protocol Identification Number
NCT05566561
Brief Title
Para-sartorial Compartment Block in Knee Surgery
Official Title
Postoperative Analgesic Efficacy of Ultrasound-guided Para-sartorial Compartment Block in Knee Surgery: A Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 19, 2022 (Actual)
Primary Completion Date
September 10, 2023 (Anticipated)
Study Completion Date
October 16, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medipol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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 adequate postoperative analgesia in knee arthroplasty. Pascarella et al. applied PSKB to a 58-year-old patient who underwent knee surgery under spinal anesthesia and had pain in the postoperative period and reported that the patient with a visual pain score of 9 decreased to 2 after the block. This study, it is aimed to evaluate the effectiveness of para-sartorial canal block for postoperative analgesia management in patients undergoing knee surgery. Our primary aim is to compare postoperative opioid consumption, and our secondary aim is to evaluate postoperative pain scores (Numerical rating scale-NRS), the presence of motor blockade, first postoperative mobilization time, and side effects (allergic reaction, nausea, vomiting, etc.) associated with opioid use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Knee Injuries, Knee Disease, Knee Arthritis
Keywords
Knee Surgery, Postoperative pain management, Postoperative Analgesia, Parasartorial compartment block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There are two models for this study. Parasartorial compartment block (PSCB) group, and control group.
Masking
ParticipantOutcomes Assessor
Masking Description
The patient and the outcomes assessor who performs postoperative pain evaluation will not know the group.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group PSCB = Parasartorial compartment block group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group C = Control group
Arm Type
Active Comparator
Arm Description
Wound infiltration will be applied by the surgical team
Intervention Type
Drug
Intervention Name(s)
Postoperative analgesia management
Intervention Description
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.
Primary Outcome Measure Information:
Title
Opioid consumption
Description
The fentanyl consumption on PCA device will be evaluated
Time Frame
Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.
Secondary Outcome Measure Information:
Title
Pain scores (Numerical Rating Scale-NRS)
Description
Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
Time Frame
Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16 and 24 hours
Title
Adverse events will be recorded
Description
Adverse events; nausea, vomiting, itching
Time Frame
Postoperative 24 hours period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with ASA classification I-III, Aged 18-75 years Who will be scheduled for knee surgery under spinal anesthesia. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bahadir Ciftci, Assoc prof, MD
Phone
+905343736865
Email
bciftci@medipol.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Yunus Atalay, Assoc prof, MD
Facility Information:
Facility Name
Istanbul Medipol University Hospital
City
Istanbul
State/Province
Bagcilar
ZIP/Postal Code
34070
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bahadir Ciftci, MD
Phone
+905325034428
Email
bciftci@medipol.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The investigators will not share IPD
Citations:
PubMed Identifier
35547556
Citation
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.
Results Reference
background
PubMed Identifier
34039734
Citation
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.
Results Reference
background
PubMed Identifier
31130273
Citation
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.
Results Reference
background

Learn more about this trial

Para-sartorial Compartment Block in Knee Surgery

We'll reach out to this number within 24 hrs