PainNCT02486549
Supraclavicular Versus Interscalene Block for Shoulder Surgery
A study testing Supraclavicular Block, Interscalene Block and Bupivacaine in people with Pain, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to compare the supraclavicular block to interscalene block in patients undergoing arthroscopic shoulder surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain
- What is being tested?
- Supraclavicular Block, Interscalene Block and Bupivacaine
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2015to Feb 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing shoulder surgery in American Society of Anesthesiologists physical status I-II
Who cannot join
- with a known allergy to study medications,
- chronic opioid use,
- ipsilateral upper limb neurological deficits,
- severe respiratory disease,
- coagulopathy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa University Medical School
Tokat Province, 60100
About this study
Official title: A Prospective Randomized Comparison of Ultrasound-guided Supraclavicular and Interscalene Block in Patients Undergoing Arthroscopic Shoulder Surgery
The purpose of this study is to compare the supraclavicular block to interscalene block in patients undergoing arthroscopic shoulder surgery.
Read the detailed description
The aim of this study is to evaluate the efficacy of the supraclavicular block in comparison with interscalene block on postoperative pain, quality of recovery and side effects in patients undergoing arthroscopic shoulder surgery under general anesthesia.
- Conditions
- Pain
- Being tested
- Supraclavicular Block, Interscalene Block, Bupivacaine, Ultrasound
- Keywords
- Pain, Anesthesia Recovery Period, Brachial Plexus
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supraclavicular BlockProcedure or surgery
Under ultrasound guidance an insulated needle is advanced with in- plane technique into the brachial plexus sheath and 20ml 0.25% bupivacaine will be administered
Interscalene BlockProcedure or surgery
Under ultrasound guidance an insulated needle will be placed through the middle scalene muscle,into the interscalene groove with in-plane technique and 20ml 0.25%bupivacaine will be administered into the brachial plexus
BupivacaineDrug
Also called Marcaine
20ml 0.25% bupivacaine will be injected for brachial plexus block
UltrasoundDevice
The Ultrasound will be used for brachial plexus visualization
| Study group | Role | What they receive |
|---|---|---|
| Supraclavicular Block | Experimental | Ultrasound guided supraclavicular block with 20 ml of 0.25% bupivacaine will be performed Receives: Procedure: Supraclavicular Block; Drug: Bupivacaine; Device: Ultrasound |
| Interscalene block | Active comparator | Ultrasound guided inter scalene block with 20ml of 0.25% bupivacaine will be performed. Receives: Procedure: Interscalene Block; Drug: Bupivacaine; Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain
The visual analog scale will be used for assessment
Measured: up to postoperative 24 hours
Secondary outcomes (7)
Quality of recovery
The Quality of Recovery-40 (QR40) questionnaire will be used for assessment
Measured: in the postoperative 24 hours
Motor block
The muscle force will be evaluated with scale 0 to 3( 0:normal muscle force, 1: reduced muscle force, 2: impaired mobility 3: paralysis
Measured: up to postoperative 24 hours
Sensory block
The sensorial block will be assessed by pinprick test.
Measured: up to postoperative 24 hours
Adverse events
The number of patients with adverse events will be recorded.
Measured: up to postoperative 24 hours
Analgesics requirement time
the first intravenous analgesic requirement time will be recorded.
Measured: up to postoperative 24 hours
Systolic Blood pressure changes
The blood pressure will be measured non invasively and the systolic blood pressure lower than 90 mmHg or decrease more than 20% of baseline will be accepted as a hypotension.
Measured: at time of surgery
Heart rate changes
The heart rate will be assessed via electrocardiographic monitoring and recorded as beat/minute.
Measured: at time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba Karaman, Tokat Gaziosmanpasa University
- Investigators
- Tugba Karamanaraman, M.D., Principal investigator, Gaziosmanpasa University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02486549
- Sponsor's protocol ID
- artroscopy
- Status last verified
- Feb 2017
- First submitted
- 24 Jun 2015
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Comparison of Ultrasound-guided Supraclavicular and Interscalene Block in Patients Undergoing Arthroscopic Shoulder Surgery
- ClinicalTrials.gov ID
- NCT02486549
- Acronym / sponsor ID
- artroscopy
- Conditions
- Pain
- Keywords
- Pain, Anesthesia Recovery Period, Brachial Plexus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 1 Jul 2015 (estimated)
- 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.
The purpose of this study is to compare the supraclavicular block to interscalene block in patients undergoing arthroscopic shoulder surgery.
Detailed description
The aim of this study is to evaluate the efficacy of the supraclavicular block in comparison with interscalene block on postoperative pain, quality of recovery and side effects in patients undergoing arthroscopic shoulder surgery under general anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supraclavicular Block | Experimental | Procedure: Supraclavicular Block, Drug: Bupivacaine, Device: UltrasoundUltrasound guided supraclavicular block with 20 ml of 0.25% bupivacaine will be performed |
| Interscalene block | Active comparator | Procedure: Interscalene Block, Drug: Bupivacaine, Device: UltrasoundUltrasound guided inter scalene block with 20ml of 0.25% bupivacaine will be performed. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing shoulder surgery in American Society of Anesthesiologists physical status I-II
Key exclusion criteria (5 listed)
- with a known allergy to study medications,
- chronic opioid use,
- ipsilateral upper limb neurological deficits,
- severe respiratory disease,
- coagulopathy
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 |
|---|---|---|
| Supraclavicular BlockUnder ultrasound guidance an insulated needle is advanced with in- plane technique into the brachial plexus sheath and 20ml 0.25% bupivacaine will be administered | Procedure or surgery | Supraclavicular Block |
| Interscalene BlockUnder ultrasound guidance an insulated needle will be placed through the middle scalene muscle,into the interscalene groove with in-plane technique and 20ml 0.25%bupivacaine will be administered into the brachial plexus | Procedure or surgery | Interscalene block |
| BupivacaineAlso: Marcaine20ml 0.25% bupivacaine will be injected for brachial plexus block | Drug | Interscalene block, Supraclavicular Block |
| UltrasoundThe Ultrasound will be used for brachial plexus visualization | Device | Interscalene block, Supraclavicular Block |
Primary outcome
Postoperative Pain
Time frame: up to postoperative 24 hours
The visual analog scale will be used for assessment
7 secondary outcomes
Quality of recovery
Time frame: in the postoperative 24 hours
Motor block
Time frame: up to postoperative 24 hours
Sensory block
Time frame: up to postoperative 24 hours
Adverse events
Time frame: up to postoperative 24 hours
Analgesics requirement time
Time frame: up to postoperative 24 hours
Systolic Blood pressure changes
Time frame: at time of surgery
Heart rate changes
Time frame: at time of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
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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.
Tugba Karamanaraman, M.D. principal investigator
Gaziosmanpasa University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supraclavicular Block, Interscalene Block and Bupivacaine in people with Pain, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
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 5 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: finished, as of the sponsor's last update on 23 Feb 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Pain (time frame: up to postoperative 24 hours). 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 23 Feb 2017.