Efficacy Testing of Different Tourniquet Pressure Used for Postoperative Pain Reduction in Total Knee Arthroplasty
NCT ID: NCT03931837
Last Updated: 2019-05-07
Study Results
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Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2019-05-01
2020-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Tourniquet: Systolic blood pressure + 75 mmHg
Before skin incision
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
Before skin incision
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
Before skin incision
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
50 Years
90 Years
ALL
Yes
Sponsors
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Boontanapibul, Krit, M.D.
INDIV
Thammasat University
OTHER
Responsible Party
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piya pinsornsak
Principal Investigator
Principal Investigators
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Piya Pinsornsak
Role: PRINCIPAL_INVESTIGATOR
Thammasat University Hospital
Locations
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Thammasat university hospital
Pathum Thani, Klongluang, Thailand
Countries
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References
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Choi YJ, Ra HJ. Patient Satisfaction after Total Knee Arthroplasty. Knee Surg Relat Res. 2016 Mar;28(1):1-15. doi: 10.5792/ksrr.2016.28.1.1. Epub 2016 Feb 29.
Norton MR, Eyres KS. Irrigation and suction technique to ensure reliable cement penetration for total knee arthroplasty. J Arthroplasty. 2000 Jun;15(4):468-74. doi: 10.1054/arth.2000.2965.
Majkowski RS, Bannister GC, Miles AW. The effect of bleeding on the cement-bone interface. An experimental study. Clin Orthop Relat Res. 1994 Feb;(299):293-7.
Juliusson R, Arve J, Ryd L. Cementation pressure in arthroplasty. In vitro study of cement penetration into femoral heads. Acta Orthop Scand. 1994 Apr;65(2):131-4. doi: 10.3109/17453679408995419.
Walker PS, Soudry M, Ewald FC, McVickar H. Control of cement penetration in total knee arthroplasty. Clin Orthop Relat Res. 1984 May;(185):155-64.
Tetro AM, Rudan JF. The effects of a pneumatic tourniquet on blood loss in total knee arthroplasty. Can J Surg. 2001 Feb;44(1):33-8.
Ejaz A, Laursen AC, Kappel A, Laursen MB, Jakobsen T, Rasmussen S, Nielsen PT. Faster recovery without the use of a tourniquet in total knee arthroplasty. Acta Orthop. 2014 Aug;85(4):422-6. doi: 10.3109/17453674.2014.931197. Epub 2014 Jun 23.
Zhang W, Li N, Chen S, Tan Y, Al-Aidaros M, Chen L. The effects of a tourniquet used in total knee arthroplasty: a meta-analysis. J Orthop Surg Res. 2014 Mar 6;9(1):13. doi: 10.1186/1749-799X-9-13.
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.
Abdel-Salam A, Eyres KS. Effects of tourniquet during total knee arthroplasty. A prospective randomised study. J Bone Joint Surg Br. 1995 Mar;77(2):250-3.
Mori N, Kimura S, Onodera T, Iwasaki N, Nakagawa I, Masuda T. Use of a pneumatic tourniquet in total knee arthroplasty increases the risk of distal deep vein thrombosis: A prospective, randomized study. Knee. 2016 Oct;23(5):887-9. doi: 10.1016/j.knee.2016.02.007. Epub 2016 Jun 29.
Kumar N, Yadav C, Singh S, Kumar A, Vaithlingam A, Yadav S. Evaluation of pain in bilateral total knee replacement with and without tourniquet; a prospective randomized control trial. J Clin Orthop Trauma. 2015 Jun;6(2):85-8. doi: 10.1016/j.jcot.2015.01.095. Epub 2015 Feb 24.
Liu D, Graham D, Gillies K, Gillies RM. Effects of tourniquet use on quadriceps function and pain in total knee arthroplasty. Knee Surg Relat Res. 2014 Dec;26(4):207-13. doi: 10.5792/ksrr.2014.26.4.207. Epub 2014 Dec 2.
Torres PA, Helmstetter JA, Kaye AM, Kaye AD. Rhabdomyolysis: pathogenesis, diagnosis, and treatment. Ochsner J. 2015 Spring;15(1):58-69.
Sharma JP, Salhotra R. Tourniquets in orthopedic surgery. Indian J Orthop. 2012 Jul;46(4):377-83. doi: 10.4103/0019-5413.98824.
Ishii Y, Matsuda Y. Effect of tourniquet pressure on perioperative blood loss associated with cementless total knee arthroplasty: a prospective, randomized study. J Arthroplasty. 2005 Apr;20(3):325-30. doi: 10.1016/j.arth.2004.10.001.
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. doi: 10.1016/s0883-5403(97)90153-4.
Other Identifiers
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MTU-EC-OT-1-183/60
Identifier Type: -
Identifier Source: org_study_id
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