NCT03256058

Brief Summary

This is a randomized controlled trial designed to research the effects of different tourniquet applications on postoperative pain in patients undergoing total knee arthroplasty, and to guide early postoperative recovery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

August 20, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 21, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

October 24, 2017

Status Verified

August 1, 2017

Enrollment Period

4 months

First QC Date

August 16, 2017

Last Update Submit

October 22, 2017

Conditions

TourniquetsTotal Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain

    tested by Visual Analogue Scale

    48 hours post surgery

Secondary Outcomes (6)

  • The rate of postoperative limb swelling

    24 hours post surgery, 48 hours post surgery

  • Endothelin-1

    one minute before tourniquet inflation, tourniquet inflation for an hour, one minute before tourniquet deflation, fifteen minutes after tourniquet deflation

  • Nitric Oxide

    one minute before tourniquet inflation, tourniquet inflation for an hour, one minute before tourniquet deflation, fifteen minutes after tourniquet deflation

  • Lac

    one minute before tourniquet inflation, tourniquet inflation for an hour, one minute before tourniquet deflation, fifteen minutes after tourniquet deflation

  • Hemoglobin

    one minute before tourniquet inflation, tourniquet inflation for an hour, one minute before tourniquet deflation, fifteen minutes after tourniquet deflation

  • +1 more secondary outcomes

Study Arms (2)

Reinflation after early deflation

ACTIVE COMPARATOR

The tourniquet would be inflated immediately before incision and deflated after the use of the cement, and 10 minutes later (after the hardening of the cement) , reinflate the tourniquet and deflate at the end of the operation.The total time of tourniquet inflation is controlled within 90 minutes.

Procedure: Reinflation after early deflation

Control

PLACEBO COMPARATOR

The tourniquet would be inflated immediately before incision and deflated at the end of the operation. The inflation of tourniquet should not last more than 90 minutes.

Procedure: Control

Interventions

Reinflation after early deflationPROCEDURE

the tourniquet would be inflated immediately before incision and deflated after the use of the cement , and 10 minutes later (after the hardening of the cement) , reinflate the tourniquet and deflate at the end of the operation. The total time of tourniquet inflation is controlled within 90 minutes.

Reinflation after early deflation
ControlPROCEDURE

The tourniquet would be inflated immediately before incision and deflated at the end of the operation. The inflation of tourniquet should not last more than 90 minutes.

Control

Eligibility Criteria

Age45 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of anesthesiologists Grade 1-3 Patients
  • Undergoing unilateral total knee arthroplasty under general anesthesia
  • Should be treated with tourniquet

You may not qualify if:

  • Tourniquet inflation time is less than 1h, greater than 1.5h
  • Abnormal coagulation function
  • BMI \< 20kg/m2 or \> 35kg/m2
  • History of cerebral infarction
  • History of Peripheral vascular disease
  • Anemia (hemoglobin\<90g/L)
  • Systolic blood pressure (SBP) ≥ 170mmHg
  • Pregnant blood glucose \> 10mmol/L or HbA1c \> 8.5% of diabetic patients
  • History of chronic narcotic use
  • Participate in other clinical trials at the same time
  • Asked to withdraw from the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221000, China

RECRUITING

Related Publications (24)

  • Rama KR, Apsingi S, Poovali S, Jetti A. Timing of tourniquet release in knee arthroplasty. Meta-analysis of randomized, controlled trials. J Bone Joint Surg Am. 2007 Apr;89(4):699-705. doi: 10.2106/JBJS.F.00497.

    PMID: 17403789RESULT

  • Hernandez AJ, Almeida AM, Favaro E, Sguizzato GT. The influence of tourniquet use and operative time on the incidence of deep vein thrombosis in total knee arthroplasty. Clinics (Sao Paulo). 2012 Sep;67(9):1053-7. doi: 10.6061/clinics/2012(09)12.

    PMID: 23018303RESULT

  • Silver R, de la Garza J, Rang M, Koreska J. Limb swelling after release of a tourniquet. Clin Orthop Relat Res. 1986 May;(206):86-9.

    PMID: 3708997RESULT

  • Butt U, Ahmad R, Aspros D, Bannister GC. Factors affecting wound ooze in total knee replacement. Ann R Coll Surg Engl. 2011 Jan;93(1):54-6. doi: 10.1308/003588410X12771863937124. Epub 2010 Sep 10.

    PMID: 20836920RESULT

  • Palmer SH, Graham G. Tourniquet-induced rhabdomyolysis after total knee replacement. Ann R Coll Surg Engl. 1994 Nov;76(6):416-7.

    PMID: 7702328RESULT

  • Gielen MJ, Stienstra R. Tourniquet hypertension and its prevention: a review. Reg Anesth. 1991 Jul-Aug;16(4):191-4. No abstract available.

    PMID: 1911493RESULT

  • Kaufman RD, Walts LF. Tourniquet-induced hypertension. Br J Anaesth. 1982 Mar;54(3):333-6. doi: 10.1093/bja/54.3.333.

    PMID: 6461346RESULT

  • Valli H, Rosenberg PH. Effects of three anaesthesia methods on haemodynamic responses connected with the use of thigh tourniquet in orthopaedic patients. Acta Anaesthesiol Scand. 1985 Jan;29(1):142-7. doi: 10.1111/j.1399-6576.1985.tb02175.x.

    PMID: 3976320RESULT

  • Kam PC, Kavanagh R, Yoong FF. The arterial tourniquet: pathophysiological consequences and anaesthetic implications. Anaesthesia. 2001 Jun;56(6):534-45. doi: 10.1046/j.1365-2044.2001.01982.x.

    PMID: 11412159RESULT

  • Valli H, Rosenberg PH, Kytta J, Nurminen M. Arterial hypertension associated with the use of a tourniquet with either general or regional anaesthesia. Acta Anaesthesiol Scand. 1987 May;31(4):279-83. doi: 10.1111/j.1399-6576.1987.tb02566.x.

    PMID: 3591250RESULT

  • Bostankolu E, Ayoglu H, Yurtlu S, Okyay RD, Erdogan G, Deniz Y, Hanci V, Can M, Turan IO. Dexmedetomidine did not reduce the effects of tourniquet-induced ischemia-reperfusion injury during general anesthesia. Kaohsiung J Med Sci. 2013 Feb;29(2):75-81. doi: 10.1016/j.kjms.2012.08.013. Epub 2012 Oct 13.

    PMID: 23347808RESULT

  • Lin L, Wang L, Bai Y, Zheng L, Zhao X, Xiong X, Jin L, Ji W, Wang W. Pulmonary gas exchange impairment following tourniquet deflation: a prospective, single-blind clinical trial. Orthopedics. 2010 Jun 9;33(6):395. doi: 10.3928/01477447-20100429-15.

    PMID: 20806768RESULT

  • Matziolis G, Drahn T, Schroder JH, Krocker D, Tuischer J, Perka C. Endothelin-1 is secreted after total knee arthroplasty regardless of the use of a tourniquet. J Orthop Res. 2005 Mar;23(2):392-6. doi: 10.1016/j.orthres.2004.08.021.

    PMID: 15734253RESULT

  • Wang BQ, Kan YF, Yang QH. [The protective effect of the limb ischemia preconditioning on the hepatic injury related to NO/ET-1 system in rats]. Zhongguo Ying Yong Sheng Li Xue Za Zhi. 2010 Aug;26(3):376-9. Chinese.

    PMID: 21038696RESULT

  • Shao D, Park JE, Wort SJ. The role of endothelin-1 in the pathogenesis of pulmonary arterial hypertension. Pharmacol Res. 2011 Jun;63(6):504-11. doi: 10.1016/j.phrs.2011.03.003. Epub 2011 Mar 16.

    PMID: 21419223RESULT

  • Luscher TF, Barton M. Endothelins and endothelin receptor antagonists: therapeutic considerations for a novel class of cardiovascular drugs. Circulation. 2000 Nov 7;102(19):2434-40. doi: 10.1161/01.cir.102.19.2434.

    PMID: 11067800RESULT

  • Tarwala R, Dorr LD, Gilbert PK, Wan Z, Long WT. Tourniquet use during cementation only during total knee arthroplasty: a randomized trial. Clin Orthop Relat Res. 2014 Jan;472(1):169-74. doi: 10.1007/s11999-013-3124-2.

    PMID: 23836239RESULT

  • Mittal R, Ko V, Adie S, Naylor J, Dave J, Dave C, Harris IA, Hackett D, Ngo D, Dietsch S. Tourniquet application only during cement fixation in total knee arthroplasty: a double-blind, randomized controlled trial. ANZ J Surg. 2012 Jun;82(6):428-33. doi: 10.1111/j.1445-2197.2012.06083.x. Epub 2012 May 10.

    PMID: 22571508RESULT

  • Chen S, Li J, Peng H, Zhou J, Fang H, Zheng H. The influence of a half-course tourniquet strategy on peri-operative blood loss and early functional recovery in primary total knee arthroplasty. Int Orthop. 2014 Feb;38(2):355-9. doi: 10.1007/s00264-013-2177-x. Epub 2013 Nov 21.

    PMID: 24258152RESULT

  • Hernandez-Castanos DM, Ponce VV, Gil F. Release of ischaemia prior to wound closure in total knee arthroplasty: a better method? Int Orthop. 2008 Oct;32(5):635-8. doi: 10.1007/s00264-007-0376-z. Epub 2007 May 15.

    PMID: 17503044RESULT

  • Wauke K, Nagashima M, Kato N, Ogawa R, Yoshino S. Comparative study between thromboembolism and total knee arthroplasty with or without tourniquet in rheumatoid arthritis patients. Arch Orthop Trauma Surg. 2002 Nov;122(8):442-6. doi: 10.1007/s00402-002-0404-9. Epub 2002 Apr 18.

    PMID: 12442180RESULT

  • Sapega AA, Heppenstall RB, Chance B, Park YS, Sokolow D. Optimizing tourniquet application and release times in extremity surgery. A biochemical and ultrastructural study. J Bone Joint Surg Am. 1985 Feb;67(2):303-14.

    PMID: 3968122RESULT

  • Kadoi Y, Ide M, Saito S, Shiga T, Ishizaki K, Goto F. Hyperventilation after tourniquet deflation prevents an increase in cerebral blood flow velocity. Can J Anaesth. 1999 Mar;46(3):259-64. doi: 10.1007/BF03012606.

    PMID: 10210051RESULT

  • Huang CH, Wang MJ, Chen TL, Huang HH, Hsu HW, Susetio L, Liu CC. Blood and central venous pressure responses after serial tourniquet deflation during bilateral total knee replacement. J Formos Med Assoc. 1996 Jun;95(6):496-9.

    PMID: 8772061RESULT

Study Officials

  • Guanglei Wang, MD

    The Affiliated Hospital of Xuzhou Medical University

    STUDY DIRECTOR

Central Study Contacts

Guanglei Wang, MD

CONTACT

+86-1385208715613852087156@163.com

Pei Liu, Bachelor

CONTACT

18361205361xzflylp@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2017

First Posted

August 21, 2017

Study Start

August 20, 2017

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

October 24, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

IPD will be available when this trial is finished and the article have been published

Locations

CN(1)