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出境医 / 临床实验 / Efficacy Testing of Different Tourniquet Pressure Used for Postoperative Pain Reduction in Total Knee Arthroplasty

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

Study Description
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Device: Tourniquet: Systolic blood pressure + 75 mmHg Device: Tourniquet: Systolic blood pressure + 100 mmHg Device: Tourniquet: Systolic blood pressure + 150 mmHg Not Applicable

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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy Testing of Different Tourniquet Pressure Used for Postoperative Pain Reduction in Total Knee Arthroplasty: A Prospective, Randomized Controlled Trials
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : July 31, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Tourniquet: Systolic blood pressure + 75 mmHg
Before skin incision
 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
Experimental: Tourniquet: Systolic blood pressure + 100 mmHg
Before skin incision
 Device: 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
Experimental: Tourniquet: Systolic blood pressure + 150 mmHg
Before skin incision
 Device: 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
Outcome Measures
Primary Outcome Measures :
  1. Postoperative visual analogue scale for pain [ Time Frame: 48 hours after operation ]
    (VAS, 0 = no pain, 10 = the worst imaginable pain)


Secondary Outcome Measures :
  1. Quality of bloodless visual field [ Time Frame: Intraoperative evaluation ]
    (QBF, 0 = the worst quality, 10 = the best quality)

  2. Changes from baseline hemoglobin concentrations [ Time Frame: 48 hours after operation ]
  3. Postoperative range of motion [ Time Frame: 2 weeks, 6 weeks and 12 weeks ]
    Record with long arm goniometer

  4. Number of patient with local soft tissue complications [ Time Frame: 14 days after the operation ]
  5. Number of patient with venous thromboembolism [ Time Frame: 14 days after the operation ]
  6. Knee society score [ Time Frame: 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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Locations
Layout table for location information
Thailand
Thammasat university hospital
Pathumthani, Klongluang, Thailand, 12120
Sponsors and Collaborators
Thammasat University
Krit Boontanapibul
Investigators
Layout table for investigator information
Principal Investigator: Piya Pinsornsak Thammasat university hospital
Tracking Information
First Submitted Date  ICMJE April 16, 2019
First Posted Date  ICMJE April 30, 2019
Last Update Posted Date May 7, 2019
Estimated Study Start Date  ICMJE May 1, 2019
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2019) 		Postoperative visual analogue scale for pain [ Time Frame: 48 hours after operation ]
(VAS, 0 = no pain, 10 = the worst imaginable pain)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2019)
  • Quality of bloodless visual field [ Time Frame: Intraoperative evaluation ]
    (QBF, 0 = the worst quality, 10 = the best quality)
  • Changes from baseline hemoglobin concentrations [ Time Frame: 48 hours after operation ]
  • Postoperative range of motion [ Time Frame: 2 weeks, 6 weeks and 12 weeks ]
    Record with long arm goniometer
  • Number of patient with local soft tissue complications [ Time Frame: 14 days after the operation ]
  • Number of patient with venous thromboembolism [ Time Frame: 14 days after the operation ]
  • Knee society score [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2019)
  • Quality of bloodless visual field [ Time Frame: Intraoperative evaluation ]
    (QBF, 0 = the worst quality, 10 = the best quality)
  • Changes from baseline hemoglobin concentrations [ Time Frame: 48 hours after operation ]
  • Postoperative range of motion [ Time Frame: 2 weeks, 6 weeks and 12 weeks ]
    Record with long arm goniometer
  • Local soft tissue complications [ Time Frame: 14 days after the operation ]
  • Number of patient with venous thromboembolism [ Time Frame: 14 days after the operation ]
  • Knee society score [ Time Frame: 6 weeks, 12 weeks and 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Testing of Different Tourniquet Pressure Used for Postoperative Pain Reduction in Total Knee Arthroplasty
Official Title  ICMJE Efficacy Testing of Different Tourniquet Pressure Used for Postoperative Pain Reduction in Total Knee Arthroplasty: A Prospective, Randomized Controlled Trials
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis, Knee
Intervention  ICMJE
  • 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
  • Device: 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
  • Device: 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
Study Arms  ICMJE
  • Experimental: Tourniquet: Systolic blood pressure + 75 mmHg
    Before skin incision
    Intervention: Device: Tourniquet: Systolic blood pressure + 75 mmHg
  • Experimental: Tourniquet: Systolic blood pressure + 100 mmHg
    Before skin incision
    Intervention: Device: Tourniquet: Systolic blood pressure + 100 mmHg
  • Experimental: Tourniquet: Systolic blood pressure + 150 mmHg
    Before skin incision
    Intervention: Device: Tourniquet: Systolic blood pressure + 150 mmHg
Publications *
  • 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. Review.
  • 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.
  • 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.
  • 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. Review.
  • 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. Review.
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 25, 2019) 		150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2020
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03931837
Other Study ID Numbers  ICMJE MTU-EC-OT-1-183/60
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party piya pinsornsak, Thammasat University
Study Sponsor  ICMJE Thammasat University
Collaborators  ICMJE Krit Boontanapibul
Investigators  ICMJE
Principal Investigator: Piya Pinsornsak Thammasat university hospital
PRS Account Thammasat University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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