Postoperative Analgesia in Bilateral Knee Arthroplasties

NCT06357013 | Completed

• 1 other identifier: 2023-40
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Arthroplasty, Total; Peripheral Nerve Block; Pain, Postoperative

Keywords

pain; pain management; nerve block

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Grup-1: Suprainguinal fascia iliaca compartment block

Procedure: Bilateral Suprainguinal fascia iliaca compartment block

Grup-2: Local infiltration analgesia

Procedure: Local infiltration analgesia

Interventions

Bilateral Suprainguinal fascia iliaca compartment block PROCEDURE

Suprainguinal fascia iliaca compartment block (S-FICB) is one of the commonly used regional analgesia techniques for postoperative analgesia in lower extremity surgeries.

Grup-1: Suprainguinal fascia iliaca compartment block

Local infiltration analgesia PROCEDURE

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.

Grup-2: Local infiltration analgesia

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18-75 years, who planned elective bilateral knee arthroplasty under spinal anesthesia, American Society of Anesthesiologists (ASA) risk score I-II.

You may qualify if:

• Planned elective bilateral knee arthroplasty under spinal anesthesia
• American Society of Anesthesiologists (ASA) risk score I-II
• Patients aged 18-75 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kocaeli City Hospital: lead

Study Sites (1)

Kocaeli City Hospital

Kocaeli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Merve Yazici Kara, MD

  Kocaeli City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: April 10, 2024
• Study Start: January 1, 2024
• Primary Completion: May 1, 2024
• Study Completion: June 30, 2024
• Last Updated: January 14, 2025

Record last verified: 2025-01

Locations

TU (1)