Yasin Tire
Konya, Meram, 42140, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07124494
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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Request Info18 year and older
All sexes
Interventional
Not applicable
Konya, Meram, 42140, Turkey (Türkiye)
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
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.
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).
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
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).
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.
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).
Contact information is provided by the study sponsor or research team.
Konya City Hospital
Other
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
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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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