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NCT Number: NCT07124494

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yasin Tire

Konya, Meram, 42140, Turkey (Türkiye)

Location status: Recruiting

Location contact

Osman Çiçekler

CONTACT

Yasin Tire

CONTACT

[email protected]

05055367970

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Minimum Age: 18 Years
  • Maximum Age: None
  • Sex: All
  • Gender Based: No
  • Accepts Healthy Volunteers: No
  • Inclusion Criteria:
  • Scheduled for primary total knee arthroplasty
  • Age ≥ 18 years
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Accepting neuraxial anesthesia
  • Exclusion Criteria:
  • 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

Treatment and study plan

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.

Primary outcomes

  1. Postoperative Knee Range of Motion (ROM)

    Time frame: Postoperative day 1, day 3, day 7, and day 90 after surgery.

    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.

Secondary outcomes

  1. Total Opioid Consumption

    Time frame: From the end of surgery to 72 hours postoperatively.

    Cumulative opioid consumption (intravenous and oral) will be recorded and converted to morphine milligram equivalents (MME).

  2. Oxford Knee Score (OKS)

    Time frame: Preoperatively (baseline) and postoperative day 90.

    Oxford Knee Score (OKS) questionnaire: Functional outcome will be evaluated using the Oxford Knee Score, a validated 12-item questionnaire assessing pain and physical function.To assess knee pain and functional ability from the patient's perspective.

    Number of questions: 12

    Score range: 0 to 48

    Interpretation:

    0 points = worst possible outcome (severe pain and poor function)

    48 points = best possible outcome (no pain and full function)

    Direction: Higher scores indicate better outcomes

  3. Visual Analog Scale (VAS) Pain Score

    Time frame: Postoperative day 1, day 3, and day 7 after surgery.

    Pain intensity at rest and during movement will be assessed using a 10-cm visual analog scale (0 = no pain, 10 = worst possible pain).

  4. Incidence of Adverse Events Related to Anesthesia or Analgesia

    Time frame: Intraoperative period and up to 90 days postoperatively.

    The occurrence of anesthesia- or analgesia-related complications (e.g., motor weakness, sensory deficits, infection at catheter site, nausea/vomiting, hypotension) will be recorded.

  5. Patient Satisfaction Score

    Time frame: Postoperative day 3 and day 90 after surgery.

    Patient satisfaction with postoperative analgesia will be assessed using a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied).

Study contacts

Contact information is provided by the study sponsor or research team.

Yasin Tire

CONTACT

[email protected]

05055367970

Sponsors and collaborators

Lead sponsor

Konya City Hospital

Other

Registry information

Official study title

Evaluation of the Effects of Regional Anesthesia Methods Applied in Total Knee Arthroplasty on Joint Range of Motion in the Postoperative Period and Patient Satisfaction

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 15, 2025
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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