Nerve BlockNCT04419246
The Effect of Intravenous Tranexamic Acid and Interscalene Block Applied on Shoulder Arthroscopy
A study testing interscalene block, tranexamic acid and general anesthesia in people with Nerve Block and Tranexamic Acid, run by Bursa Yuksek Ihtisas Training and Research Hospital.
Trial summary
Nerve blocks are used for pain and surgery after many operations today. It has been demonstrated by studies that the amount of postoperative bleeding decreases. On the other hand, surgical teams can use additional medications, such as Tranexamic acid, which have been proven by different studies that have reduced… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nerve Block, Tranexamic Acid
- What is being tested?
- interscalene block, tranexamic acid and general anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2020to 15 Jul 2021
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who were in the American Society of Anesthesiologists (ASA) I-III class
- underwent elective shoulder arthroscopy
- Patients with consent to participate in the study
Who cannot join
- history of arterial or venous thromboembolic disease
- Bleeding diathesis disorder
- Allergy to local anesthetics
- cardiac stent placement
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Intravenous Tranexamic Acid and Interscalene Block Applied on Shoulder Arthroscopy on Total Blood Loss; a Prospective, Randomized, Controlled Trial
Nerve blocks are used for pain and surgery after many operations today. It has been demonstrated by studies that the amount of postoperative bleeding decreases. On the other hand, surgical teams can use additional medications, such as Tranexamic acid, which have been proven by different studies that have reduced bleeding during and after arthroscopic surgery.
Read the detailed description
The investigators aimed to investigate the effect of interscalene block application and tranexamic acid on bleeding in shoulder arthroscopy operation.
- Conditions
- Nerve Block, Tranexamic Acid
- Being tested
- interscalene block, tranexamic acid, general anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interscalene blockOther
ultrasound guided ultrasound guided interscalene block 30 minutes before operation. 30 minutes before operation.
tranexamic acidDrug
10 mg/kg intravenous tranexamic acid 10 minutes before the incision.
general anesthesiaOther
general anesthesia will be applied in accordance with standard procedures
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | interscalene block + General anesthesia Receives: Other: interscalene block; Other: general anesthesia |
| Group T | Active comparator | Tranexamic acid +General anesthesia Receives: Drug: tranexamic acid; Other: general anesthesia |
| Group S | Sham comparator | General anesthesia Receives: Other: general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum hemoglobin exchange
change of serum hemoglobin before and after operation
Measured: preoperative, postoperative 1st and 2nd day
Secondary outcomes (2)
postoperative bleeding amount
The volume of drainage
Measured: postoperative 24 hours
Visual Analog Scale
Visual Analog Scale was used for pain.Pain intensity was measured using 0-10 cm visual analogue scale (VAS). (0= no pain, 10=intolerable pain)
Measured: Postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start15 Jul 2020 (estimated)
- Primary completion15 Jul 2020 (estimated)
- Study completion15 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve BlockStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Korgün Ökmen, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04419246
- Sponsor's protocol ID
- Bursa BYIERH
- Status last verified
- Jun 2020
- First submitted
- 3 Jun 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intravenous Tranexamic Acid and Interscalene Block Applied on Shoulder Arthroscopy on Total Blood Loss; a Prospective, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT04419246
- Acronym / sponsor ID
- Bursa BYIERH
- Conditions
- Nerve Block, Tranexamic Acid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 15 Jul 2020 (estimated)
- Primary completion
- 15 Jul 2020 (estimated)
- Study completion
- 15 Jul 2021 (estimated)
- First posted
- 5 Jun 2020 (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.
Nerve blocks are used for pain and surgery after many operations today. It has been demonstrated by studies that the amount of postoperative bleeding decreases. On the other hand, surgical teams can use additional medications, such as Tranexamic acid, which have been proven by different studies that have reduced bleeding during and after arthroscopic surgery.
Detailed description
The investigators aimed to investigate the effect of interscalene block application and tranexamic acid on bleeding in shoulder arthroscopy operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Other: interscalene block, Other: general anesthesiainterscalene block + General anesthesia |
| Group T | Active comparator | Drug: tranexamic acid, Other: general anesthesiaTranexamic acid +General anesthesia |
| Group S | Sham comparator | Other: general anesthesiaGeneral anesthesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who were in the American Society of Anesthesiologists (ASA) I-III class
- underwent elective shoulder arthroscopy
- Patients with consent to participate in the study
Key exclusion criteria (4 listed)
- history of arterial or venous thromboembolic disease
- Bleeding diathesis disorder
- Allergy to local anesthetics
- cardiac stent placement
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 |
|---|---|---|
| interscalene blockultrasound guided ultrasound guided interscalene block 30 minutes before operation. 30 minutes before operation. | Other | Group I |
| tranexamic acid10 mg/kg intravenous tranexamic acid 10 minutes before the incision. | Drug | Group T |
| general anesthesiageneral anesthesia will be applied in accordance with standard procedures | Other | Group I, Group S, Group T |
Primary outcome
serum hemoglobin exchange
Time frame: preoperative, postoperative 1st and 2nd day
change of serum hemoglobin before and after operation
2 secondary outcomes
postoperative bleeding amount
Time frame: postoperative 24 hours
Visual Analog Scale
Time frame: Postoperative 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing interscalene block, tranexamic acid and general anesthesia in people with Nerve Block and Tranexamic Acid, run by Bursa Yuksek Ihtisas Training and Research Hospital.
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 4 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 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Korgün Ökmen, Assoc. PhD. (+902242955000, korgunokmen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum hemoglobin exchange (time frame: preoperative, postoperative 1st and 2nd day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2020.