Cryotherapy, Knee Osteoarthritis, Opioid Consumption, Postoperative, Postoperative Pain Management, Total Knee Arthroplasty
Conditions
Keywords
Total Knee Arthroplasty, Preoperative Cold Therapy, Cryotherapy, Postoperative Pain, Opioid Consumption, Knee Surgery, Drainage Output
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREPreoperative and Postoperative Cold Therapy with Gel Cold Pack
Cold therapy was applied using a conventional gel cold pack , pre-cooled at -17°C for at least 2 hours. In the intervention group, cold application was performed three times before surgery (20 minutes per session with 40-minute intervals), and continued postoperatively for 24 hours with the same frequency. This protocol aimed to reduce pain, swelling, bleeding, and improve functional outcomes after total knee arthroplasty.
PROCEDUREPostoperative Cold Therapy with Gel Cold Pack
Cold therapy applied only in the postoperative period, for 24 hours, using the same method as the intervention group (20-minute applications with 40-minute breaks.
Sponsors
Ankara City Hospital Bilkent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Masking description
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.
Intervention model description
Participants were randomized 1:1 into two parallel groups to receive either preoperative and postoperative cold therapy or only postoperative cold therapy.
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 55 years * Diagnosed with advanced stage primary osteoarthritis of the knee * Scheduled for unilateral primary total knee arthroplasty * Provided written informed consent
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Thigh Circumference Measurement | 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. |
| Total Opioid Consumption in the First 48 Hours | 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 | 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) | 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. |
| Visual Analog Scale (VAS) Scores for Pain | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for Blood Transfusion | From Surgery Until Hospital Discharge(2 to 7 Days Postoperative) | The number of patients who required postoperative blood transfusion was recorded and compared between the groups. The transfusion threshold was hemoglobin \<8 g/dL in hemodynamically stable patients. The outcome will be assessed throughout the hospitalization period after surgery. |
| Length of Hospital Stay | Through Hospital Discharge (Estimated 2 to 7 Days Postoperative) | The duration of hospitalization in days was recorded for each patient, from the day of surgery until discharge. |
| Presence of Ecchymosis | 24 Hours Postoperative and 48 Hours Postoperative | Ecchymosis was visually evaluated and recorded at 24 hours postoperatively and 48 hours postoperatively in both groups. |
Countries
Turkey (Türkiye)
Outcome results
None listed