Does Tourniquet Use Have an Effect on Pain and Function After Total Knee Arthroplasty
Condition: Arthropathy of Knee; Pain, Joint
MeSH terms: Arthralgia
Study type: Interventional

Summary: 
      Total knee arthroplasty (TKA) is an effective surgical procedure for reducing knee joint pain
      and improving the quality of life of patients with advanced knee osteoarthritis. Although
      advanced surgical techniques and prosthesis design are achieved, postoperative pain is a
      significant factor that affects those patients who have undergone TKA with a satisfactory
      outcome. The reasons for postoperative pain after TKA are somewhat unclear Although there are
      studies evaluating the preoperative and postoperative conditions of the patients using pain
      scores, these values differ greatly in patients who are suitable for the same procedure.
      Previous studies have demonstrated that variability exists between individuals in basal pain
      sensitivity, which is assessed using quantitative sensory testing To our knowledge, only one
      study has investigated the pain condition using an algometer and postoperative pain and the
      analgesic requirement on the day of surgery and during the postoperative period.Unlike the
      above-cited study, in this study, we evaluated the effect of using a tourniquet on
      early-stage pain and 1-year postoperative functional outcomes when patients were divided into
      two groups according to the pain threshold.
    

Detailed description: 
      This is a prospective double-blinded, randomized controlled trial diagnostic study conducted
      at a single center from June 2018 to December 2019. Patients who underwent total knee
      arthroplasty due to end-stage knee osteoarthritis were asked to volunteer to participate in
      this study. A prospective randomized study was conducted using a digital algometer to assess
      the pain sensitivity for the relationship between postoperative early-stage pain score and
      first-year functional scores in patients with or without using tourniquet who underwent
      primary TKA. Patients were randomized to with or without tourniquet groups; a random number
      generated by the research staff determined the group designation, independent of a senior
      surgeon. T All participants in this study gave their written informed consent. Patients with
      a neurological disorder, diagnosed with fibromyalgia, history of knee operation, valgus knee,
      greater than 30° flexion contracture that had undergone bilateral knee arthroplasty or
      revision knee arthroplasty, chronic analgesic users, and those with a psychiatric disease
      were excluded from this study.

      Preoperative Procedure: All patients had anterior-posterior and lateral radiographs of the
      bilateral knees, taken with a standard full-length weight-bearing the patients in bipedal
      stance, the knees in maximal extension for anterior-posterior and 30-degree flexion for
      lateral radiographs pre and postoperatively. In all patients, range of motion and
      contractures of both knee joints were recorded. All patient's educational level was also
      assessed. The pain threshold (PT) was evaluated using an analog algometer (Figure 1). The
      pain sensitivity was measured on the forearm using two mechanical pain stressors, which
      indicate which of an ascending sensory stimulus is first perceived as painful. This device is
      a force gauge that is used to apply an increasing amount of force to the skin through a 1 cm2
      surface area until the pain threshold is achieved. This algometer stimulates pain, described
      as dull pressure at the pain threshold; the reliability and validity of this device have been
      reported. The pain sensitivity of all measurement patients was taken on the day before the
      surgery by the same author, and these values were blinded from another author who recorded
      the repetitive postoperative VAS and knee scores.

      Operation Procedure: All patients were operated on in a single-center and experiences in
      arthroplasty practice. All the patients were operated on standard spinal anesthesia. All
      patients underwent cruciate-retaining Genesis II knee arthroplasty (Smith and Nephew,
      Memphis, TN, USA) with a midline incision and medial parapatellar approach with a fixed
      bearing design. Patella resurfacing was not performed, while patellar denervation was
      performed in all patients. Bone-cement (40 g) was used with a fourth-generation cementing
      device.

      A pneumatic tourniquet was used before surgery at the proximal thigh and inflated before the
      skin incision until skin closure in group 1 and no used in group 2. The tourniquet was
      inflated to either 275 or 325 mmHg, depending on the patient's systolic blood pressure.
      Peri-operative tranexamic (TXA) acid was administrated intravenously with 20 mg/kg 30 min
      before surgery. Periarticular injection was not used for pain control in either group. An
      adductor canal block or epidural analgesia was not applied. Intra-articular drainage was used
      in every patient, which was removed after 24 h postoperatively.

      Postoperative Management and Analgesic Procedure: On the day of surgery, intravenous
      paracetamol 1 g was given at 8-h intervals, and intramuscular diclofenac sodium 75 mg and
      intravenous tramadol 100 mg in 100 mL normal saline were given at 12-h intervals. This
      analgesic procedure was continued at the time of discharge, and all patients were discharged
      on the third day of surgery. Physical therapy was started on postoperative day 1 in all
      patients. The functional assessments and range-of-motion were measured during routine
      physical therapy sessions.

      Postoperative Assessment of Pain and Function: VAS score assessment was done at 24 h (rest),
      36 h (post-physical therapy), and 48 h (rest) postoperatively. The Knee Society Clinical
      Scoring System (KSS) was also used for evaluation of functional outcomes, which is a
      condition-specific validated questionnaire widely used to evaluate the functional
      capabilities of the knee joint before and after total knee arthroplasty. The KSS was done in
      the first year postoperatively. The KSS consists of two parts. One part is the knee score
      (KSS1), which includes pain (maximum 50 points), stability, total range of flexion, and other
      items (varus, valgus, extension delay, and flexion contracture). The other part (KSS2) is the
      function score, which has two components, walking capacity and stair-climbing ability and
      deductions done if the patient using any assistive devices.
    

Intervention name(s): Using Tourniquet
Intervention type(s): Procedure
Intervention description(s): The purpose of this prospective randomized double blinded study was to compare the effect of using a tourniquet on early-stage pain and 1-year postoperative functional outcomes when patients were divided into two groups according to the pain threshold.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: Knee Arthroplasty