Efficacy of Peripheral Nerve Blocks in Total Knee Arthroplasty

NCT07040709 | Recruiting

• 1 other identifier: 24-AKD-143
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain Following Knee Arthroplasty

Keywords

Knee Replacement Arthroplasty; Postoperative Pain; Nerve Block

Outcome Measures

Primary Outcomes (1)

• Numeric Rating Scale (NRS)

  Numeric Rating Scale (NRS), is a simple and widely used tool for patients to rate their pain intensity. It typically involves asking the patient to select a number from 0 to 10, where: 0 indicates no pain at all, 10 represents the worst pain imaginable.

  Postoperative patients will be visited and their pain scores will be evaluated at 1st, 3rd, 6th, 9th, 12th, 15th, 18th, 21st, and 24th hours

Secondary Outcomes (2)

• Total opioid consumption

  The total amount of administered opioid (tramadol hydrochloride) within the first 24 hours postoperatively.

• The patient's knee extension capability

  Postoperative patients will be visited and their knee extension capability will be evaluated at 1st, 3rd, 6th, 9th, 12th, 15th, 18th, 21st, and 24th hours.

Study Arms (2)

Group A

ACTIVE COMPARATOR

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.

Other: Opioid Analgesic (tramadol hydrochloride); Other: Prophylactic analgesia (intravenous paracetamol); Other: Rescue analgesia (intramuscular diclofenac sodium)

Group S

ACTIVE COMPARATOR

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.

Other: Opioid Analgesic (tramadol hydrochloride); Other: Prophylactic analgesia (intravenous paracetamol); Other: Rescue analgesia (intramuscular diclofenac sodium)

Interventions

Opioid Analgesic (tramadol hydrochloride) 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.

Group A; Group S

Prophylactic analgesia (intravenous paracetamol) 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).

Group A; Group S

Rescue analgesia (intramuscular diclofenac sodium) 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 A; Group S

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tokat Gaziosmanpasa University: lead

Study Sites (1)

Tokat Gaziosmanpasa University

Tokat Province, ABD Veya Kanada'daysanız Lütfen Seçin..., 60100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Analgesics, Opioid; Tramadol

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Central Study Contacts

Ali Genç, Assistant professor

CONTACT

+90-3562129500; aligenc0860@outlook.com

Muzaffer Katar, Associate Professor

CONTACT

0 (356) 212 95 00 - 7515; Muzaffer.katar@gop.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: 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.

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 27, 2025
• Study Start: June 8, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)