TourniquetsNCT03256058
Tourniquet Application on Total Knee Arthroplasty
A study testing Reinflation after early deflation in people with Tourniquets and Total Knee Arthroplasty, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Tourniquets, Total Knee Arthroplasty
- What is being tested?
- Reinflation after early deflation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2017to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of anesthesiologists Grade 1-3 Patients
- Undergoing unilateral total knee arthroplasty under general anesthesia
- Should be treated with tourniquet
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000
Guanglei Wang, MD, +86-13852087156, 13852087156@163.com
Pei Liu, Bachelor, 18361205361, xzflylp@163.com
About this study
Official title: The Effect of Different Applications of Tourniquet on Total Knee Arthroplasty
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.
Read the detailed description
Sixty participants undergoing unilateral TKA would be recruited in this study. On one side, 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. On the other side the tourniquet would be inflated immediately before incision and deflated at the end of the operation.The total time of tourniquet inflation is controlled within 90 minutes. The postoperative pain, limb swelling , the score of surgical field, blood pressure during the operation, blood loss, operating time, transfusion rate, deep vein thrombosis (DVT) incidence and clinical outcomes would be monitored for comparison.
- Conditions
- Tourniquets, Total Knee Arthroplasty
- Being tested
- Reinflation after early deflation, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reinflation after early deflationProcedure or surgery
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.
ControlProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
tested by Visual Analogue Scale
Measured: 48 hours post surgery
Secondary outcomes (6)
The rate of postoperative limb swelling
test the perimeter of the surgary limb at four fingers under the inguen,then Calculate the rate by formula (postoperative perimeter-preoperative perimeter)/preoperative perimeter
Measured: 24 hours post surgery, 48 hours post surgery
Endothelin-1
tested by ELISA
Measured: one minute before tourniquet inflation, tourniquet inflation for an hour, one minute before tourniquet deflation, fifteen minutes after tourniquet deflation
Nitric Oxide
tested by ELISA
Measured: one minute before tourniquet inflation, tourniquet inflation for an hour, one minute before tourniquet deflation, fifteen minutes after tourniquet deflation
Lac
blood gas analysis mmol/L
Measured: one minute before tourniquet inflation, tourniquet inflation for an hour, one minute before tourniquet deflation, fifteen minutes after tourniquet deflation
Hemoglobin
blood gas analysis g/L
Measured: one minute before tourniquet inflation, tourniquet inflation for an hour, one minute before tourniquet deflation, fifteen minutes after tourniquet deflation
partial pressure of oxygen in artery
blood gas analysis mmHg
Measured: one minute before tourniquet inflation, tourniquet inflation for an hour, one minute before tourniquet deflation, fifteen minutes after tourniquet deflation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start20 Aug 2017
- Primary completion31 Dec 2017 (estimated)
- Study completion31 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for TourniquetsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guanglei Wang, MD, Study director, The Affiliated Hospital of Xuzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03256058
- Sponsor's protocol ID
- XYFY-2017-052
- Status last verified
- Aug 2017
- First submitted
- 16 Aug 2017
- Last updated
- 24 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be available when this trial is finished and the article have been published
Publications
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.
PubMed 17403789Hernandez 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.
PubMed 23018303Silver 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.
PubMed 3708997Butt 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.
PubMed 20836920Palmer SH, Graham G. Tourniquet-induced rhabdomyolysis after total knee replacement. Ann R Coll Surg Engl. 1994 Nov;76(6):416-7.
PubMed 7702328Gielen MJ, Stienstra R. Tourniquet hypertension and its prevention: a review. Reg Anesth. 1991 Jul-Aug;16(4):191-4. No abstract available.
PubMed 1911493Kaufman RD, Walts LF. Tourniquet-induced hypertension. Br J Anaesth. 1982 Mar;54(3):333-6. doi: 10.1093/bja/54.3.333.
PubMed 6461346Valli 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.
PubMed 3976320Kam 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.
PubMed 11412159Valli 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.
PubMed 3591250Bostankolu 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.
PubMed 23347808Lin 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.
PubMed 20806768Matziolis 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.
PubMed 15734253Wang 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.
PubMed 21038696Shao 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.
PubMed 21419223
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Applications of Tourniquet on Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03256058
- Acronym / sponsor ID
- XYFY-2017-052
- Conditions
- Tourniquets, Total Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 20 Aug 2017 (actual)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 21 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Sixty participants undergoing unilateral TKA would be recruited in this study. On one side, 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. On the other side the tourniquet would be inflated immediately before incision and deflated at the end of the operation.The total time of tourniquet inflation is controlled within 90 minutes. The postoperative pain, limb swelling , the score of surgical field, blood pressure during the operation, blood loss, operating time, transfusion rate, deep vein thrombosis (DVT) incidence and clinical outcomes would be monitored for comparison.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reinflation after early deflation | Active comparator | Procedure: Reinflation after early deflationThe 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. |
| Control | Placebo comparator | Procedure: ControlThe 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. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of anesthesiologists Grade 1-3 Patients
- Undergoing unilateral total knee arthroplasty under general anesthesia
- Should be treated with tourniquet
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reinflation after early deflationthe 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 or surgery | Reinflation after early deflation |
| ControlThe 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 or surgery | Control |
Primary outcome
Postoperative pain
Time frame: 48 hours post surgery
tested by Visual Analogue Scale
6 secondary outcomes
The rate of postoperative limb swelling
Time frame: 24 hours post surgery, 48 hours post surgery
Endothelin-1
Time frame: one minute before tourniquet inflation, tourniquet inflation for an hour, one minute before tourniquet deflation, fifteen minutes after tourniquet deflation
Nitric Oxide
Time frame: one minute before tourniquet inflation, tourniquet inflation for an hour, one minute before tourniquet deflation, fifteen minutes after tourniquet deflation
Lac
Time frame: one minute before tourniquet inflation, tourniquet inflation for an hour, one minute before tourniquet deflation, fifteen minutes after tourniquet deflation
Hemoglobin
Time frame: one minute before tourniquet inflation, tourniquet inflation for an hour, one minute before tourniquet deflation, fifteen minutes after tourniquet deflation
partial pressure of oxygen in artery
Time frame: one minute before tourniquet inflation, tourniquet inflation for an hour, one minute before tourniquet deflation, fifteen minutes after tourniquet deflation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2017.
- Results publication: PubMed 17403789Rama 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.
- Results publication: PubMed 23018303Hernandez 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.
- Results publication: PubMed 3708997Silver 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.
- Results publication: PubMed 20836920Butt 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.
- Results publication: PubMed 7702328Palmer SH, Graham G. Tourniquet-induced rhabdomyolysis after total knee replacement. Ann R Coll Surg Engl. 1994 Nov;76(6):416-7.
- Results publication: PubMed 1911493Gielen MJ, Stienstra R. Tourniquet hypertension and its prevention: a review. Reg Anesth. 1991 Jul-Aug;16(4):191-4. No abstract available.
- Results publication: PubMed 6461346Kaufman RD, Walts LF. Tourniquet-induced hypertension. Br J Anaesth. 1982 Mar;54(3):333-6. doi: 10.1093/bja/54.3.333.
- Results publication: PubMed 3976320Valli 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.
- Results publication: PubMed 11412159Kam 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.
- Results publication: PubMed 3591250Valli 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.
- Results publication: PubMed 23347808Bostankolu 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.
- Results publication: PubMed 20806768Lin 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.
- Individual participant dataSharing planned: No. IPD will be available when this trial is finished and the article have been published
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Analgesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guanglei Wang, MD study director
The Affiliated Hospital of Xuzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reinflation after early deflation in people with Tourniquets and Total Knee Arthroplasty, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guanglei Wang, MD (+86-13852087156, 13852087156@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: 48 hours post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03256058, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2017.