Efficacy Testing of Different Tourniquet Pressure Used for Postoperative Pain Reduction in Total Knee Arthroplasty

Conditions

Osteoarthritis, Knee

Keywords

Tourniquet, Total knee arthroplasty, Postoperative pain, Range of motion, Wound complication

Brief summary

Tourniquet use during total knee replacement (TKR) improves visibility, significantly decreases intra-operative blood loss and reduce operative time. However, tourniquet use also has a negative effect on postoperative pain, postoperative range of motion(ROM), wound complication, deep vein thrombosis (DVT), pulmonary embolism (PE), thigh muscle strength, and functional recovery after TKR. Therefore, the investigators conducted a three-arm prospective, randomized, controlled trial study to compare the efficacy of different tourniquet pressure used between systolic blood pressure + 75 mmHg, systolic blood pressure + 100 mmHg, and systolic blood pressure + 150 mmHg.

Detailed description

Patients scheduled for unilateral primary TKA; 150 patients were randomly assigned to receive tourniquet pressure used of systolic blood pressure + 75 mmHg, systolic blood pressure + 100 mmHg, and systolic blood pressure + 150 mmHg. All patients had spinal anesthesia, the same operative procedure, and postoperative pain protocol. A visual analogue scale (VAS) for pain were recorded 24, 48 hours, and 2 weeks postoperatively. Quality of bloodless visual field and calculated blood loss were evaluated perioperatively. Postoperative ROM, wound complication, deep vein thrombosis (DVT), pulmonary embolism (PE) were recorded at 2, 6, and 12 weeks. Furthermore, Knee Society Score (KSS) also recorded at 6 weeks, 3 and 6 months. The reviewers were blinded to the treatment group.

Related papers

No related papers found yet.

Interventions

DEVICETourniquet: Systolic blood pressure + 75 mmHg

Spinal block without morphine. Medial parapatellar approach. Same posterior stabilized design and operated by a single surgeon. Drug: Peri-articular Transmine(15 mg/kg) combined with multimodal local anesthetic infiltration (0.5% bupivacaine 100 mg, morphine sulfate 5 mg, 0.1% epinephrine 0.6 mg, and ketorolac 30 mg) mixed NSS up to 75 mL. Procedure/Surgery: TXA combined with multimodal local anesthetic infiltration inject into peri-articular area (Anterior soft tissue 25 mL+Medial gutter area 25 mL+Lateral gutter area 25 mL) prior to capsular closure and tourniquet deflation

DEVICETourniquet: Systolic blood pressure + 100 mmHg

Spinal block without morphine. Medial parapatellar approach. Same posterior stabilized design and operated by a single surgeon. Drug: Peri-articular Transmine(15 mg/kg) combined with multimodal local anesthetic infiltration (0.5% bupivacaine 100 mg, morphine sulfate 5 mg, 0.1% epinephrine 0.6 mg, and ketorolac 30 mg) mixed NSS up to 75 mL. Procedure/Surgery: TXA combined with multimodal local anesthetic infiltration inject into peri-articular area (Anterior soft tissue 25 mL+Medial gutter area 25 mL+Lateral gutter area 25 mL) prior to capsular closure and tourniquet deflation

DEVICETourniquet: Systolic blood pressure + 150 mmHg

Spinal block without morphine. Medial parapatellar approach. Same posterior stabilized design and operated by a single surgeon. Drug: Peri-articular Transmine(15 mg/kg) combined with multimodal local anesthetic infiltration (0.5% bupivacaine 100 mg, morphine sulfate 5 mg, 0.1% epinephrine 0.6 mg, and ketorolac 30 mg) mixed NSS up to 75 mL. Procedure/Surgery: TXA combined with multimodal local anesthetic infiltration inject into peri-articular area (Anterior soft tissue 25 mL+Medial gutter area 25 mL+Lateral gutter area 25 mL) prior to capsular closure and tourniquet deflation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to 90 Years

Healthy volunteers

Yes

Inclusion criteria

* Adult patients with osteoarthritis in need of a TKR

Exclusion criteria

* Inflammatory arthritis * Post-traumatic arthritis * Body mass index \> 30 Kg/m2 * A history of or current venous thromboembolic disease * Any underlying disease of hemostasis, cirrhosis, chronic renal failure, patients on anticoagulants or strong antiplatelet drugs (e.g. warfarin, clopidogrel) * Preoperative hemoglobin \<10 g/dL or a platelet count \< 140,000 /uL3 * Allergy to transamine

Design outcomes

Primary

Measure	Time frame	Description
Postoperative visual analogue scale for pain	48 hours after operation	(VAS, 0 = no pain, 10 = the worst imaginable pain)

Secondary

Measure	Time frame	Description
Changes from baseline hemoglobin concentrations	48 hours after operation	—
Postoperative range of motion	2 weeks, 6 weeks and 12 weeks	Record with long arm goniometer
Quality of bloodless visual field	Intraoperative evaluation	(QBF, 0 = the worst quality, 10 = the best quality)
Number of patient with venous thromboembolism	14 days after the operation	—
Knee society score	6 weeks, 12 weeks and 6 months	Score from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions
Number of patient with local soft tissue complications	14 days after the operation	—

Countries

Thailand

Outcome results

None listed