The Effect of Preoperatively Initiated Cold Application on Postoperative Bleeding, Pain, and Functional Status in Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS) Scores for Pain
研究概览
简要总结
This prospective, single-center, randomized controlled trial investigates the effects of preoperative cold therapy on early postoperative outcomes in patients undergoing unilateral primary total knee arthroplasty (TKA). A total of 208 patients were randomized into two groups: one receiving conventional cold therapy preoperatively and postoperatively, and the other receiving only routine postoperative cold therapy. Primary outcomes included postoperative pain (VAS), edema (thigh circumference), hemoglobin levels, drainage volume, opioid usage, Knee Society Scores (KSS), and presence of ecchymosis. The study demonstrated that initiating cold therapy before surgery significantly reduced postoperative drainage and opioid requirement, and delayed early edema progression. These findings suggest that the timing of cold therapy may influence recovery, highlighting a potentially beneficial approach to perioperative care in TKA.
详细描述
This prospective, single-center, randomized controlled study aims to evaluate the early postoperative effects of initiating cold therapy in the preoperative period in patients undergoing total knee arthroplasty (TKA). While cold therapy is routinely applied in the postoperative period to reduce pain, swelling, and inflammation, limited evidence exists regarding the impact of starting cold therapy before surgery. In this study, a total of 208 patients diagnosed with advanced degenerative knee osteoarthritis and scheduled for unilateral primary cemented TKA were randomly assigned to two groups: one receiving conventional gel-based cold therapy both preoperatively and postoperatively (intervention group), and one receiving only standard postoperative cold therapy (control group).
Cold therapy was applied using gel packs at -17°C for 20 minutes with 40-minute intervals. The intervention group received three preoperative sessions prior to surgery and continued postoperatively for 48 hours. The control group received only the postoperative protocol.
The primary outcomes were postoperative pain (measured using Visual Analog Scale - VAS), edema (thigh circumference), hemoglobin levels, drainage output at 24 hours, and opioid consumption during the first 48 hours. Secondary outcomes included Knee Society Scores (KSS), hospital stay duration, and presence of ecchymosis.
The results demonstrated that preoperative initiation of cold therapy significantly reduced postoperative drainage volume and opioid consumption, and showed a trend toward slower edema progression and lower pain scores in the early postoperative period. This study proposes a novel approach in perioperative management by emphasizing the importance of cold therapy timing, and provides evidence that beginning therapy preoperatively may enhance recovery outcomes after TKA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
盲法说明
Care providers such as nurses and physiotherapists responsible for postoperative rehabilitation and routine care were blinded to group allocation. Patients and outcome assessors were not blinded.
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 55 years
- •Diagnosed with advanced stage primary osteoarthritis of the knee
- •Scheduled for unilateral primary total knee arthroplasty
- •Provided written informed consent
排除标准
- •Secondary osteoarthritis (e.g., post-traumatic, inflammatory arthritis)
- •History of prior surgery on the affected knee
- •Known hypersensitivity or intolerance to cold
- •Comorbidities contraindicating cold therapy (e.g., diabetes mellitus, cold urticaria, peripheral vascular disease)
- •Bleeding diathesis or on anticoagulant therapy
- •History of severe hypertension or cardiovascular disease
- •Active neurological or psychiatric disorder
- •Allergy to medications used in the study protocol
- •Refusal to participate in the study
研究组 & 干预措施
Preoperative and Postoperative Cold Therapy
Patients in this group received conventional cold therapy (gel pack at -17°C) both before and after surgery. Three sessions were applied preoperatively (20 minutes with 40-minute intervals), and postoperative therapy was performed identically to the control group (20 minutes on / 40 minutes off for 24 hours).
干预措施: Preoperative and Postoperative Cold Therapy with Gel Cold Pack (Procedure)
Postoperative Cold Therapy Only
Patients in this group received conventional cold therapy (gel pack at -17°C) after surgery only. Cold packs were applied to the knee region for 20 minutes with 40-minute intervals over a 24-hour postoperative period.
干预措施: Postoperative Cold Therapy with Gel Cold Pack (Procedure)
结局指标
主要结局
Visual Analog Scale (VAS) Scores for Pain
时间窗: Preoperative, 8 Hours Postoperative, 24 Hours Postoperative, 48 Hours Postoperative
Pain intensity was assessed using the Visual Analog Scale (VAS) at rest at four time points: Preoperative, 8 Hours Postoperative, 24 Hours Postoperative, 48 Hours Postoperative Scale Range: 0 (no pain) - 10 (worst imaginable pain) Directionality: Higher scores indicate worse pain
Postoperative Drainage Volume
时间窗: First 24 hours after surgery
Total amount of fluid collected in the Hemovac drainage system during the first 24 hours after total knee arthroplasty (TKA). This measure is used as an indicator of postoperative bleeding and local inflammation, comparing the effect of preoperative cold therapy.
Total Opioid Consumption in the First 48 Hours
时间窗: First 48 hours after surgery
Total opioid usage calculated as oral morphine equivalent in the first 48 hours after TKA. This includes all administered analgesics converted into oral morphine equivalent doses to evaluate pain control efficacy between study groups.
Hemoglobin Level Change
时间窗: Preoperative, 8 Hours Postoperative, 24 Hours Postoperative, 48 Hours Postoperative
Hemoglobin levels were recorded at four time points to evaluate perioperative blood loss: Preoperative, 8 Hours Postoperative, 24 Hours Postoperative, 48 Hours Postoperative
Knee Society Score (KSS)
时间窗: Preoperative and 48 Hours Postoperative
Functional outcomes were measured using the KSS scale, which includes pain, range of motion, and stability. Scores were compared preoperatively and at 48 hours postoperatively. Each component is scored from 0 to 100, with higher scores indicating better outcomes.
Thigh Circumference Measurement
时间窗: Preoperative, 24 Hours Postoperative, 48 Hours Postoperative
Thigh circumference was measured 1 cm proximal to the superior patella border with the knee in full extension, to assess postoperative swelling. Measurements were taken preoperatively, 24 hours postoperatively, and 48 hours postoperatively.
次要结局
- Length of Hospital Stay(Through Hospital Discharge (Estimated 2 to 7 Days Postoperative))
- Presence of Ecchymosis(24 Hours Postoperative and 48 Hours Postoperative)
- Need for Blood Transfusion(From Surgery Until Hospital Discharge(2 to 7 Days Postoperative))
研究者
Omer Faruk Naldoven
Orthopedic Surgeon
Ankara City Hospital Bilkent