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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined Spinal-Epidural Anesthesia | Active Comparator | Postoperative analgesia will be provided via epidural catheter with programmed infusion of bupivacaine . |
|
| Adductor Canal Block | Active Comparator | Ultrasound-guided adductor canal catheter placement and continuous infusion of bupivacaine . |
|
| Multimodal Intravenous Analgesia | Sham Comparator | Continuous intravenous tramadol infusion with rescue analgesia as required. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Opioid Consumption | Cumulative opioid consumption (intravenous and oral) will be recorded and converted to morphine milligram equivalents (MME). | From the end of surgery to 72 hours postoperatively. |
| Oxford Knee Score (OKS) |
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Minimum Age: 18 Years
Maximum Age: None
Sex: All
Gender Based: No
Accepts Healthy Volunteers: No
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yasin Tire | Contact | 05055367970 | dryasintire@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yasin Tire | Recruiting | Konya | Meram | 42140 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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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
| Preoperatively (baseline) and postoperative day 90. |
| Visual Analog Scale (VAS) Pain Score | Pain intensity at rest and during movement will be assessed using a 10-cm visual analog scale (0 = no pain, 10 = worst possible pain). | Postoperative day 1, day 3, and day 7 after surgery. |
| Incidence of Adverse Events Related to Anesthesia or Analgesia | The occurrence of anesthesia- or analgesia-related complications (e.g., motor weakness, sensory deficits, infection at catheter site, nausea/vomiting, hypotension) will be recorded. | Intraoperative period and up to 90 days postoperatively. |
| Patient Satisfaction Score | Patient satisfaction with postoperative analgesia will be assessed using a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied). | Postoperative day 3 and day 90 after surgery. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |