Efficacy of Peripheral Nerve Blocks in Total Knee Arthroplasty

NCT ID: NCT07040709

Last Updated: 2025-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-08

Study Completion Date

2026-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

In total knee arthroplasty, the effectiveness of some peripheral nerve blocks in postoperative pain control has been investigated, with conflicting results reported. The primary aim of this study is to evaluate the effects of the suprainguinal fascia iliaca plane block, which is routinely performed in our clinic for postoperative pain management, and the adductor canal block in patients undergoing total knee arthroplasty under spinal anesthesia. Patients scheduled for total knee arthroplasty under spinal anesthesia will be randomly assigned using computer-generated randomization into two groups: the adductor canal block group (Group A) and the suprainguinal fascia iliaca plane block group (Group S). The nerve blocks will be performed by a single investigator according to the assigned group. Postoperative follow-up assessments will be conducted and recorded by a different investigator who is blinded to which nerve block was performed.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study will be conducted on patients undergoing total knee arthroplasty with spinal anesthesia at the operating room of Gaziosmanpaşa University Research and Application Hospital. Patients aged between 18 and 75 years, with American Society of Anesthesiologists (ASA) scores of 1-3, will be included in the study. Patients with a history of chronic pain, allergy to opioids or local anesthetics, psychiatric conditions that impair cooperation, or those who do not wish to participate voluntarily will be excluded.

Patients will be randomly assigned into two groups using a computer-generated randomization: the adductor canal block group (Group A) and the suprainguinal fascia iliaca plane block group (Group S). Postoperative monitoring in the recovery unit will include non-invasive measurements of ECG, blood pressure, heart rate, and SpO2.

According to their assigned group, patients will receive either ultrasound-guided suprainguinal fascia iliaca plane block or adductor canal block for postoperative analgesia control. Patients will be observed in the recovery room for an adequate period, after which a patient-controlled analgesia (PCA) pump will be routinely applied in our clinic. The PCA will be infused with an opioid-containing solution at an appropriate dose, and detailed patient information will be provided. Instead of continuous infusion, the device will deliver bolus doses intermittently when the patient's numeric rating scale (NRS) score reaches 4 or higher. If the patient's pain score remains 4 or above despite analgesic administration, routine intramuscular dicloron as rescue analgesia will be administered in our clinic. Patients will be periodically visited in bed, and data will be recorded regarding pain scores, motor strength of the operated limb, opioid consumption, use of rescue analgesia, and any complications. Follow-up assessments will be performed by a single experienced Anesthesiology and Reanimation specialist.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Pain Following Knee Arthroplasty

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients undergoing total knee arthroplasty under spinal anesthesia will be randomly assigned by computer-generated randomization into one of two groups: the adductor canal block group (Group A) or the suprainguinal fascia iliaca plane block group (Group S). After the surgical procedure, depending on the assigned group, the postoperative analgesia will be managed with ultrasound-guided suprainguinal fascia iliaca plane block or adductor canal block.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A

A patient who underwent total knee arthroplasty under spinal anesthesia will receive an adductor canal block, which is routinely performed with ultrasound guidance at our clinic for postoperative pain management. Postoperative patients will be visited at the 1st, 3rd, 6th, 9th, 12th, 15th, 18th, 21st, and 24th hours to assess pain, nausea, vomiting, itching, motor strength of the operated leg, and total opioid consumption.

Group Type ACTIVE_COMPARATOR

Opioid Analgesic (tramadol hydrochloride)

Intervention Type OTHER

For postoperative pain management, a patient-controlled analgesia (PCA) pump will be routinely applied to the patient in our clinic. An infusion of an opioid (tramadol hydrochloride) at an appropriate dose will be administered via intravenous route through the pump, and the patient will be provided with detailed information about its use. Instead of continuous infusion, the device will deliver intermittent bolus doses when the patient's numeric rating scale (NRS) score is 4 or higher.

Prophylactic analgesia (intravenous paracetamol)

Intervention Type OTHER

All patients will receive routine prophylactic analgesia with 1 gram of intravenous paracetamol every 6 hours (which may be skipped if the patient's pain score is 2 or below and they do not request pain relief).

Rescue analgesia (intramuscular diclofenac sodium)

Intervention Type OTHER

If the pain persists despite the administered analgesics and the patient's pain score remains 4 or above, rescue analgesia with intramuscular diclofenac sodium, which is routinely used in our clinic, will be administered.

Group S

A patient who underwent total knee arthroplasty under spinal anesthesia will receive an suprainguinal fascia iliac plane block, which is routinely performed with ultrasound guidance at our clinic for postoperative pain management. Postoperative patients will be visited at the 1st, 3rd, 6th, 9th, 12th, 15th, 18th, 21st, and 24th hours to assess pain, nausea, vomiting, itching, motor strength of the operated leg, and total opioid consumption.

Group Type ACTIVE_COMPARATOR

Opioid Analgesic (tramadol hydrochloride)

Intervention Type OTHER

For postoperative pain management, a patient-controlled analgesia (PCA) pump will be routinely applied to the patient in our clinic. An infusion of an opioid (tramadol hydrochloride) at an appropriate dose will be administered via intravenous route through the pump, and the patient will be provided with detailed information about its use. Instead of continuous infusion, the device will deliver intermittent bolus doses when the patient's numeric rating scale (NRS) score is 4 or higher.

Prophylactic analgesia (intravenous paracetamol)

Intervention Type OTHER

All patients will receive routine prophylactic analgesia with 1 gram of intravenous paracetamol every 6 hours (which may be skipped if the patient's pain score is 2 or below and they do not request pain relief).

Rescue analgesia (intramuscular diclofenac sodium)

Intervention Type OTHER

If the pain persists despite the administered analgesics and the patient's pain score remains 4 or above, rescue analgesia with intramuscular diclofenac sodium, which is routinely used in our clinic, will be administered.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Opioid Analgesic (tramadol hydrochloride)

For postoperative pain management, a patient-controlled analgesia (PCA) pump will be routinely applied to the patient in our clinic. An infusion of an opioid (tramadol hydrochloride) at an appropriate dose will be administered via intravenous route through the pump, and the patient will be provided with detailed information about its use. Instead of continuous infusion, the device will deliver intermittent bolus doses when the patient's numeric rating scale (NRS) score is 4 or higher.

Intervention Type OTHER

Prophylactic analgesia (intravenous paracetamol)

All patients will receive routine prophylactic analgesia with 1 gram of intravenous paracetamol every 6 hours (which may be skipped if the patient's pain score is 2 or below and they do not request pain relief).

Intervention Type OTHER

Rescue analgesia (intramuscular diclofenac sodium)

If the pain persists despite the administered analgesics and the patient's pain score remains 4 or above, rescue analgesia with intramuscular diclofenac sodium, which is routinely used in our clinic, will be administered.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients aged between 18 and 75 years
* Patients classified as ASA I, II, or III based on physical status
* Patients scheduled for total knee arthroplasty under spinal anesthesia

Exclusion Criteria

* Patients with chronic pain conditions.
* Patients with a history of allergy to opioids or local anesthetics.
* Patients with psychiatric disorders that may impair cooperation.
* Patients with bleeding disorders or those using anticoagulant therapy.
* Patients unwilling to participate voluntarily in the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tokat Gaziosmanpasa University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ali Genc

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tokat Gaziosmanpasa University

Tokat Province, ABD Veya Kanada'daysanız Lütfen Seçin..., Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ali Genç, Assistant professor

Role: CONTACT

+90-3562129500 ext. +90-5442280060

Muzaffer Katar, Associate Professor

Role: CONTACT

0 (356) 212 95 00 - 7515

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ali Genç, Associate professor

Role: primary

+90 356 212 95 00 - 7515

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

24-AKD-143

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.