Regional Anesthesia in TKA: Impact on Postoperative Joint Motion and Patient Satisfaction

NCT07124494 | Recruiting

• 1 other identifier: Study Epidural
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, prospective, randomized controlled trial aiming to evaluate the effects of different regional anesthesia/analgesia techniques on postoperative knee range of motion (ROM) and patient satisfaction following total knee arthroplasty (TKA). Ninety patients undergoing elective TKA under spinal anesthesia will be randomly assigned to one of three groups: 1) spinal anesthesia with epidural catheter, 2) spinal anesthesia followed by adductor canal catheterization, and 3) spinal anesthesia with multimodal intravenous analgesia. The primary outcome is postoperative knee joint ROM measured on postoperative days 1, 2, and 3. Secondary outcomes include patient satisfaction, Oxford Knee Score, postoperative opioid consumption, and VAS scores. The study is conducted at Konya City Hospital and will be completed over a 6-month period.

Conditions

Total Knee Arthroplasty; Postoperative Pain; Regional Anesthesia; Knee Range of Motion; Patient Satisfaction

Outcome Measures

Primary Outcomes (1)

• Postoperative Knee Range of Motion (ROM)

  Knee joint flexion and extension range of motion will be measured using a standard goniometer by a blinded assessor. Measurements will be performed with the patient in a supine position, ensuring standardized positioning for all participants.

  Postoperative day 1, day 3, day 7, and day 90 after surgery.

Secondary Outcomes (5)

• Total Opioid Consumption

  From the end of surgery to 72 hours postoperatively.

• Oxford Knee Score (OKS)

  Preoperatively (baseline) and postoperative day 90.

• Visual Analog Scale (VAS) Pain Score

  Postoperative day 1, day 3, and day 7 after surgery.

• Incidence of Adverse Events Related to Anesthesia or Analgesia

  Intraoperative period and up to 90 days postoperatively.

• Patient Satisfaction Score

  Postoperative day 3 and day 90 after surgery.

Study Arms (3)

Combined Spinal-Epidural Anesthesia

ACTIVE COMPARATOR

Postoperative analgesia will be provided via epidural catheter with programmed infusion of bupivacaine .

Procedure: Regional anethesia

Adductor Canal Block

ACTIVE COMPARATOR

Ultrasound-guided adductor canal catheter placement and continuous infusion of bupivacaine .

Procedure: Regional anethesia

Multimodal Intravenous Analgesia

SHAM COMPARATOR

Continuous intravenous tramadol infusion with rescue analgesia as required.

Procedure: Regional anethesia

Interventions

Regional anethesia PROCEDURE

This single-center, prospective, randomized controlled trial aims to compare the effects of three different postoperative analgesia techniques following spinal anesthesia in patients undergoing total knee arthroplasty (TKA). The study will assess the impact of combined spinal-epidural anesthesia, adductor canal block, and multimodal intravenous analgesia on postoperative knee range of motion (ROM). Secondary outcomes include patient satisfaction, opioid consumption, Oxford Knee Score (OKS), activity levels, and visual analog scale (VAS) pain scores.

Adductor Canal Block; Combined Spinal-Epidural Anesthesia; Multimodal Intravenous Analgesia

Eligibility Criteria

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

You may qualify if:

• Scheduled for primary total knee arthroplasty
• Age ≥ 18 years
• American Society of Anesthesiologists (ASA) physical status I-III
• Accepting neuraxial anesthesia

You may not qualify if:

• Skin infection at the planned injection site
• Sepsis
• Coagulopathy
• Refusal of neuraxial anesthesia
• Severe hypovolemia
• Demyelinating central nervous system disease
• Age under 18 years
• Illiterate in Turkish
• Non-cooperative patients
• Known allergy or hypersensitivity to bupivacaine

Sponsors & Collaborators

• Konya City Hospital: lead

Study Sites (1)

Yasin Tire

Konya, Meram, 42140, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Patient Satisfaction

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Yasin Tire

CONTACT

05055367970; dryasintire@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr. Yasin Tire

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 15, 2025
• Study Start: August 5, 2025
• Primary Completion: February 12, 2026
• Study Completion: February 19, 2026
• Last Updated: August 28, 2025

Record last verified: 2025-08

Locations

TU (1)