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

Osteoarthritis, Knee Clinical Trial

Official title:

Efficacy Testing of Different Tourniquet Pressure Used for Postoperative Pain Reduction in Total Knee Arthroplasty: A Prospective, Randomized Controlled Trials

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03931837
• Other study ID #: MTU-EC-OT-1-183/60
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: July 31, 2020

Study information

• Verified date: April 2019
• Source: Thammasat University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: July 31, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee
• Pain, Postoperative

Intervention

Device:
• Tourniquet: 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
• Tourniquet: 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
• Tourniquet: 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

Locations

Country	Name	City	State
Thailand	Thammasat university hospital	Pathumthani	Klongluang

Sponsors (2)

Lead Sponsor	Collaborator
Thammasat University	Krit Boontanapibul

Country where clinical trial is conducted

Thailand, 

References & Publications (17)

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Lohmann-Jensen R, Holsgaard-Larsen A, Emmeluth C, Overgaard S, Jensen C. The efficacy of tourniquet assisted total knee arthroplasty on patient-reported and performance-based physical function: a randomized controlled trial protocol. BMC Musculoskelet Disord. 2014 Mar 29;15:110. doi: 10.1186/1471-2474-15-110. — View Citation

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Worland RL, Arredondo J, Angles F, Lopez-Jimenez F, Jessup DE. Thigh pain following tourniquet application in simultaneous bilateral total knee replacement arthroplasty. J Arthroplasty. 1997 Dec;12(8):848-52. — View Citation

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* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative visual analogue scale for pain	(VAS, 0 = no pain, 10 = the worst imaginable pain)	48 hours after operation
Secondary	Quality of bloodless visual field	(QBF, 0 = the worst quality, 10 = the best quality)	Intraoperative evaluation
Secondary	Changes from baseline hemoglobin concentrations		48 hours after operation
Secondary	Postoperative range of motion	Record with long arm goniometer	2 weeks, 6 weeks and 12 weeks
Secondary	Number of patient with local soft tissue complications		14 days after the operation
Secondary	Number of patient with venous thromboembolism		14 days after the operation
Secondary	Knee society score	Score from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions	6 weeks, 12 weeks and 6 months