Para-sartorial Compartment Block in Knee Surgery

Sponsor
Medipol University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05566561
Collaborator
(none)
60
1
2
2.9
20.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Postoperative analgesia management
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
There are two models for this study. Parasartorial compartment block (PSCB) group, and control group.There are two models for this study. Parasartorial compartment block (PSCB) group, and control group.
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
The patient and the outcomes assessor who performs postoperative pain evaluation will not know the group.
Primary Purpose:
Treatment
Official Title:
Postoperative Analgesic Efficacy of Ultrasound-guided Para-sartorial Compartment Block in Knee Surgery: A Randomized Study
Actual Study Start Date :
Oct 19, 2022
Anticipated Primary Completion Date :
Jan 10, 2023
Anticipated Study Completion Date :
Jan 16, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group PSCB = Parasartorial compartment block group

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
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.

Active Comparator: Group C = Control group

Wound infiltration will be applied by the surgical team

Drug: Postoperative analgesia management
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.

Outcome Measures

Primary Outcome Measures

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

    The fentanyl consumption on PCA device will be evaluated

Secondary Outcome Measures

  1. Pain scores (Numerical Rating Scale-NRS) [Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16 and 24 hours]

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

  2. Adverse events will be recorded [Postoperative 24 hours period]

    Adverse events; nausea, vomiting, itching

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul Medipol University Hospital Istanbul Bagcilar Turkey 34070

Sponsors and Collaborators

  • Medipol University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Bahadir Ciftci, Primary researcher, Medipol University
ClinicalTrials.gov Identifier:
NCT05566561
Other Study ID Numbers:
  • Medipol Hospital 31
First Posted:
Oct 4, 2022
Last Update Posted:
Oct 21, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Bahadir Ciftci, Primary researcher, Medipol University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 21, 2022