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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06357013
Other study ID # 2023-40
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 2024
Est. completion date May 30, 2024

Study information

Verified date May 2024
Source Kocaeli City Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To observationally compare the analgesic efficacy of LIA and S-FICB techniques and to record the pain scores of patients who underwent bilateral knee operations in the postoperative period.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date May 30, 2024
Est. primary completion date May 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Planned elective bilateral knee arthroplasty under spinal anesthesia - American Society of Anesthesiologists (ASA) risk score I-II - Patients aged 18-75 years Exclusion Criteria: - Those receiving general anesthesia, - Those with epidural catheters, - Those who refused to participate in the study, - Those whose spinal anesthesia failed and returned to general anesthesia, - Those with a body mass index (BMI) >30 kg/m2, - History of chronic opioid or corticosteroid use, - Patients with psychiatric or neurological problems that would not allow assessment of pain using a visual analog scale (VAS) will be excluded. - In addition, patients whose surgery lasted <40 minutes or >120 minutes will also be excluded to keep the data homogeneous.

Study Design


Intervention

Procedure:
Bilateral Suprainguinal fascia iliaca compartment block
Suprainguinal fascia iliaca compartment block (S-FICB) is one of the commonly used regional analgesia techniques for postoperative analgesia in lower extremity surgeries.
Local infiltration analgesia
Local infiltration analgesia is applied to the posterior part of the knee, including the periosteum, ligaments, muscle and/or skin area before closing the surgical field.

Locations

Country Name City State
Turkey Kocaeli City Hospital Kocaeli

Sponsors (1)

Lead Sponsor Collaborator
Kocaeli City Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Suprainguinal fascia iliaca compartment block (S-FICB) produces adequate analgesic effect in knee arthroplasty. The aim of this study was to observationally compare the analgesic efficacy of local infiltration analgesia (LIA) and suprainguinal fascia iliaca compartment block (S-FICB) techniques in patients who underwent bilateral knee operations. Postoperative pain follow-up of the patients will be done by recording Visual analog scales (VAS) at 4, 8, 12 and 24 hours. Additional analgesic needs and unwanted side effects will also be recorded. 4 months
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