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CompletedNCT06386575Updated Aug 6, 2024

Suprainguinal Fascia Iliaca Block in Knee Arthroplasty

An interventional study of control group; Patients who received physiological saline and suprainguinal fascia block; Patients receiving local anesthetic in Analgesia and Anesthesia, Local, sponsored by Konya City Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-08-06.

Sponsored by Konya City Hospital · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Total knee arthroplasty is the most commonly performed orthopedic surgery, especially in patients with advanced gonarthrosis and limited joint movement. After total knee arthroplasty, patients experience unbearably severe pain. Pain that is not adequately treated in the postoperative period increases the stress response in patients, increases the risk of embolism, causes bleeding in the surgical area, and causes undesirable conditions such as agitation and delirium in patients. This postoperative pain is successfully treated with various variants of multimodal analgesia.

Read the detailed description

Total knee arthroplasty is the most commonly performed orthopedic surgery, especially in patients with advanced gonarthrosis and limited joint movement. After total knee arthroplasty, patients experience unbearably severe pain. Pain that is not adequately treated in the postoperative period increases the stress response in patients, increases the risk of embolism, causes bleeding in the surgical area, and causes undesirable conditions such as agitation and delirium in patients. This postoperative pain is successfully treated with various variants of multimodal analgesia.

The primary purpose of this study is; To evaluate the effects of suprainguinal fascia iliaca block on recovery and recovery in the postoperative period in patients who will undergo total knee arthroplasty surgery, using the quality of recovery-15T score.

Secondary purpose; Postoperative rest and movement numeric rating scale, patient likert scale, first rescue analgesia duration, number of patients needing rescue analgesia, total amount of rescue analgesic consumed, complications such as nausea and vomiting, and antiemetic requirements in patients who will undergo total knee arthroplasty surgery with suprainguinal fascia iliaca block is to evaluate.

02

Conditions studied

  • Analgesia
  • Anesthesia, Local
03

In context

Lead sponsor

Konya City Hospital is the lead sponsor of 76 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients who will undergo unilateral total knee arthroplasty
  • Patients who will undergo spinal anesthesia
  • Patients aged 18-65 years, ASA I-III
  • Patients who will stay in the hospital for at least 24 hours

Exclusion criteria

Exclusion Criteria:

  • Patients who do not want to give consent
  • Patients who do not want spinal anesthesia
  • Patients for whom regional anesthesia is contraindicated
  • Patients with confusion
  • Patients with coagulopathy
  • Patients using anticoagulants
  • Patients with infection in the area to be treated
  • Those who are allergic to local anesthesia
  • Emergency cases
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (actual)

Study arms

  • Other
    control group

    Other: control group; Patients who received physiological saline

  • Active comparator
    suprainguinal fascia iliaca block

    Other: suprainguinal fascia block; Patients receiving local anesthetic

Interventions

  • Othercontrol group; Patients who received physiological saline

    All patients will be given 1 gram of paracetamol intravenously + 20 milligrams of tenoxicam + 8 milligrams of decort intravenously. Paracetamol 3x1 gram + tenoxicam 2x20 milligrams will continue to be administered. Patients in the control group will be given 40 milliliters of physiological saline during the suprainguinal fascia iliaca block.

  • Othersuprainguinal fascia block; Patients receiving local anesthetic

    All patients will be given 1 gram of paracetamol intravenously + 20 milligrams of tenoxicam + 8 milligrams of decort intravenously. Paracetamol 3x1 gram + tenoxicam 2x20 milligrams will continue to be administered. Patients in the sfıb group will be given 40 milliliters of 0.25 % bupivacaine during the suprainguinal fascia iliaca block.

06

What researchers measure

Primary outcomes

  1. quality of recovery-15T

    Quality of recovery-15T scores, which show the quality of recovery of the patients, will be recorded at the 24th hour after the surgery. Quality of recovery-15T (0-150, 0= lowest degree of satisfaction, 150= highest degree of satisfaction).

    Time frame: One day

07

Study locations

1 site
  • Konya City Hospital
    Konya, 42020, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06386575
Lead sponsor
Konya City Hospital
Responsible party
Muhammed Halit Satici (Specialist, Department of Anesthesiology, Konya City Hospital, M.D, Konya City Hospital) — Principal investigator
First posted
Apr 26, 2024
Start date
Jun 6, 2024
Primary completion
Aug 1, 2024
Completion
Aug 3, 2024
Last update
Aug 6, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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