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

NCT03931837 | Unknown DMC

• 1 other identifier: MTU-EC-OT-1-183/60
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Postoperative visual analogue scale for pain

  (VAS, 0 = no pain, 10 = the worst imaginable pain)

  48 hours after operation

Secondary Outcomes (6)

• Quality of bloodless visual field

  Intraoperative evaluation

• Changes from baseline hemoglobin concentrations

  48 hours after operation

• Postoperative range of motion

  2 weeks, 6 weeks and 12 weeks

• Number of patient with local soft tissue complications

  14 days after the operation

• Number of patient with venous thromboembolism

  14 days after the operation

Study Arms (3)

Tourniquet: Systolic blood pressure + 75 mmHg

EXPERIMENTAL

Before skin incision

Device: Tourniquet: Systolic blood pressure + 75 mmHg

Tourniquet: Systolic blood pressure + 100 mmHg

EXPERIMENTAL

Before skin incision

Device: Tourniquet: Systolic blood pressure + 100 mmHg

Tourniquet: Systolic blood pressure + 150 mmHg

EXPERIMENTAL

Before skin incision

Device: Tourniquet: Systolic blood pressure + 150 mmHg

Interventions

Tourniquet: Systolic blood pressure + 75 mmHg DEVICE

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 + 75 mmHg

Tourniquet: Systolic blood pressure + 100 mmHg DEVICE

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

Tourniquet: Systolic blood pressure + 150 mmHg DEVICE

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

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with osteoarthritis in need of a TKR

You may not qualify if:

• 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

Sponsors & Collaborators

• Thammasat University: lead
• Boontanapibul, Krit, M.D.: collaborator

Study Sites (1)

Thammasat university hospital

Pathum Thani, Klongluang, 12120, Thailand

Location

Related Publications (17)

• 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.

  PMID: 26955608 BACKGROUND

• 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.

  PMID: 10884207 BACKGROUND

• 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.

  PMID: 8119032 BACKGROUND

• 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.

  PMID: 8197842 BACKGROUND

• 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.

  PMID: 6705374 BACKGROUND

• 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.

  PMID: 11220796 BACKGROUND

• 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.

  PMID: 24954487 BACKGROUND

• 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.

  PMID: 24602486 BACKGROUND

• 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.

  PMID: 24678741 BACKGROUND

• 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.

  PMID: 7706340 BACKGROUND

• 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.

  PMID: 27372555 BACKGROUND

• 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.

  PMID: 25983513 BACKGROUND

• 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.

  PMID: 25505702 BACKGROUND

• Torres PA, Helmstetter JA, Kaye AM, Kaye AD. Rhabdomyolysis: pathogenesis, diagnosis, and treatment. Ochsner J. 2015 Spring;15(1):58-69.

  PMID: 25829882 BACKGROUND

• Sharma JP, Salhotra R. Tourniquets in orthopedic surgery. Indian J Orthop. 2012 Jul;46(4):377-83. doi: 10.4103/0019-5413.98824.

  PMID: 22912509 BACKGROUND

• 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.

  PMID: 15809950 BACKGROUND

• 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.

  PMID: 9458249 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain, Postoperative

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Piya Pinsornsak

  Thammasat University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 30, 2019
• Study Start: May 1, 2019
• Primary Completion: April 30, 2020
• Study Completion: July 31, 2020
• Last Updated: May 7, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)