Osteoarthritis, KneeNCT03931837
Efficacy Testing of Different Tourniquet Pressure Used for Postoperative Pain Reduction in Total Knee Arthroplasty
A study testing Tourniquet: Systolic blood pressure + 75 mmHg, Tourniquet: Systolic blood pressure + 100 mmHg and Tourniquet: Systolic blood pressure + 150 mmHg in people with Osteoarthritis, Knee, run by Thammasat University at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Tourniquet: Systolic blood pressure + 75 mmHg, Tourniquet: Systolic blood pressure + 100 mmHg and Tourniquet: Systolic blood pressure + 150 mmHg
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteThailand
- Study dates
- 1 May 2019to 31 Jul 2020
- 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 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients with osteoarthritis in need of a TKR
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy Testing of Different Tourniquet Pressure Used for Postoperative Pain Reduction in Total Knee Arthroplasty: A Prospective, Randomized Controlled Trials
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.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Tourniquet: Systolic blood pressure + 75 mmHg, Tourniquet: Systolic blood pressure + 100 mmHg, Tourniquet: Systolic blood pressure + 150 mmHg
- Keywords
- Tourniquet, Total knee arthroplasty, Postoperative pain, Range of motion, Wound complication
- Medical subject headings
- Osteoarthritis, Knee, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tourniquet: Systolic blood pressure + 75 mmHgDevice
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 mmHgDevice
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 mmHgDevice
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 group | Role | What they receive |
|---|---|---|
| Tourniquet: Systolic blood pressure + 75 mmHg | Experimental | Before skin incision Receives: Device: Tourniquet: Systolic blood pressure + 75 mmHg |
| Tourniquet: Systolic blood pressure + 100 mmHg | Experimental | Before skin incision Receives: Device: Tourniquet: Systolic blood pressure + 100 mmHg |
| Tourniquet: Systolic blood pressure + 150 mmHg | Experimental | Before skin incision Receives: Device: Tourniquet: Systolic blood pressure + 150 mmHg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative visual analogue scale for pain
(VAS, 0 = no pain, 10 = the worst imaginable pain)
Measured: 48 hours after operation
Secondary outcomes (6)
Quality of bloodless visual field
(QBF, 0 = the worst quality, 10 = the best quality)
Measured: Intraoperative evaluation
Changes from baseline hemoglobin concentrations
Measured: 48 hours after operation
Postoperative range of motion
Record with long arm goniometer
Measured: 2 weeks, 6 weeks and 12 weeks
Number of patient with local soft tissue complications
Measured: 14 days after the operation
Number of patient with venous thromboembolism
Measured: 14 days after the operation
Knee society score
Score from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions
Measured: 6 weeks, 12 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start1 May 2019 (estimated)
- Primary completion30 Apr 2020 (estimated)
- Study completion31 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Collaborators
- Boontanapibul, Krit, M.D.
- Responsible party
- Principal investigator, piya pinsornsak, Thammasat University
- Investigators
- Piya Pinsornsak, Principal investigator, Thammasat University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03931837
- Sponsor's protocol ID
- MTU-EC-OT-1-183/60
- Status last verified
- Apr 2019
- First submitted
- 16 Apr 2019
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26955608Norton 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.
PubMed 10884207Majkowski 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.
PubMed 8119032Juliusson 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.
PubMed 8197842Walker PS, Soudry M, Ewald FC, McVickar H. Control of cement penetration in total knee arthroplasty. Clin Orthop Relat Res. 1984 May;(185):155-64.
PubMed 6705374Tetro 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.
PubMed 11220796Ejaz 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.
PubMed 24954487Zhang 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.
PubMed 24602486Lohmann-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.
PubMed 24678741Abdel-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.
PubMed 7706340Mori 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.
PubMed 27372555Kumar 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.
PubMed 25983513Liu 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.
PubMed 25505702Torres PA, Helmstetter JA, Kaye AM, Kaye AD. Rhabdomyolysis: pathogenesis, diagnosis, and treatment. Ochsner J. 2015 Spring;15(1):58-69.
PubMed 25829882Sharma JP, Salhotra R. Tourniquets in orthopedic surgery. Indian J Orthop. 2012 Jul;46(4):377-83. doi: 10.4103/0019-5413.98824.
PubMed 22912509
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Testing of Different Tourniquet Pressure Used for Postoperative Pain Reduction in Total Knee Arthroplasty: A Prospective, Randomized Controlled Trials
- ClinicalTrials.gov ID
- NCT03931837
- Acronym / sponsor ID
- MTU-EC-OT-1-183/60
- Conditions
- Osteoarthritis, Knee
- Keywords
- Tourniquet, Total knee arthroplasty, Postoperative pain, Range of motion, Wound complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Collaborators
- Boontanapibul, Krit, M.D.
- Study start
- 1 May 2019 (estimated)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 30 Apr 2019 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tourniquet: Systolic blood pressure + 75 mmHg | Experimental | Device: Tourniquet: Systolic blood pressure + 75 mmHgBefore skin incision |
| Tourniquet: Systolic blood pressure + 100 mmHg | Experimental | Device: Tourniquet: Systolic blood pressure + 100 mmHgBefore skin incision |
| Tourniquet: Systolic blood pressure + 150 mmHg | Experimental | Device: Tourniquet: Systolic blood pressure + 150 mmHgBefore skin incision |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with osteoarthritis in need of a TKR
Key exclusion criteria (7 listed)
- 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)
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 |
|---|---|---|
| Tourniquet: Systolic blood pressure + 75 mmHgSpinal 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 + 75 mmHg |
| Tourniquet: Systolic blood pressure + 100 mmHgSpinal 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 |
| Tourniquet: Systolic blood pressure + 150 mmHgSpinal 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 |
Primary outcome
Postoperative visual analogue scale for pain
Time frame: 48 hours after operation
(VAS, 0 = no pain, 10 = the worst imaginable pain)
6 secondary outcomes
Quality of bloodless visual field
Time frame: Intraoperative evaluation
Changes from baseline hemoglobin concentrations
Time frame: 48 hours after operation
Postoperative range of motion
Time frame: 2 weeks, 6 weeks and 12 weeks
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- Background: PubMed 26955608Choi 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.
- Background: PubMed 10884207Norton 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.
- Background: PubMed 8119032Majkowski 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.
- Background: PubMed 8197842Juliusson 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.
- Background: PubMed 6705374Walker PS, Soudry M, Ewald FC, McVickar H. Control of cement penetration in total knee arthroplasty. Clin Orthop Relat Res. 1984 May;(185):155-64.
- Background: PubMed 11220796Tetro 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.
- Background: PubMed 24954487Ejaz 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.
- Background: PubMed 24602486Zhang 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.
- Background: PubMed 24678741Lohmann-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.
- Background: PubMed 7706340Abdel-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.
- Background: PubMed 27372555Mori 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.
- Background: PubMed 25983513Kumar 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.
- Individual participant dataSharing planned: No
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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.
Piya Pinsornsak principal investigator
Thammasat University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tourniquet: Systolic blood pressure + 75 mmHg, Tourniquet: Systolic blood pressure + 100 mmHg and Tourniquet: Systolic blood pressure + 150 mmHg in people with Osteoarthritis, Knee, run by Thammasat University at 1 site in Thailand.
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 1 inclusion and 7 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 7 May 2019. 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 Thailand. 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative visual analogue scale for pain (time frame: 48 hours after operation). 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 NCT03931837, which also lists 17 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 7 May 2019.