Shoulder PainNCT04194385
Upper Trunk Block Versus Costoclavicular Block For Arthroscopic Shoulder Surgery
A study testing Upper trunk block, Costoclavicular block and Diaphragmatic function assessment in people with Shoulder Pain and Phrenic Nerve Paralysis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Interscalene brachial plexus block is known as the gold standard for analgesia after shoulder surgery, but limits the use of ipsilateral phrenic nerve paralysis. Recently, interest in potential diaphragm-sparing alternative blocks has increased for patients undergoing shoulder surgery.Two of these blocks are upper… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Shoulder Pain, Phrenic Nerve Paralysis
- What is being tested?
- Upper trunk block, Costoclavicular block and Diaphragmatic function assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2020to Jun 2023
- 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
- American Association of Anesthesiologists (ASA) physical status I - III
- BMI 20 to 35 kg / m2
- Patients scheduled for elective arthroscopic shoulder surgery
Who cannot join
- Patients who refuse to participate in the study,
- Pre-existing (obstructive or restrictive) lung disease,
- Coagulopathy,
- Sepsis,
- Hepatic or renal insufficiency,
- Pregnancy
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- Allergy to local anesthetic drugs,
- Chronic pain condition requiring opioid intake at home,
- Surgery in the neck or infraclavicular region
- BMI above 40.
- History of psychiatric diseases needing treatment.
- Failure of nerve block performed in the preoperative block room
- Substance abuse history
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bezmialem Vakıf University
Istanbul, Fatih, 34093
Serdar Yeşiltaş, Assist.Prof
About this study
Official title: Comparison of Perioperative Analgesic Efficacy of Ultrasonography Guided Upper Trunk Block and Costoclavicular Infraclavicular Brachial Plexus Block in Arthroscopic Shoulder Surgery
Interscalene brachial plexus block is known as the gold standard for analgesia after shoulder surgery, but limits the use of ipsilateral phrenic nerve paralysis. Recently, interest in potential diaphragm-sparing alternative blocks has increased for patients undergoing shoulder surgery.Two of these blocks are upper trunk block (UTB) and costoclavicular brachial plexus (CCBPB) block. This randomized controlled trial will compare ultrasound-guided UTB and CCBPB in patients undergoing arthroscopic shoulder surgery.
The main outcome is pain intensity score at 30 minutes after arrival in the post anesthesia care unit (PACU) as measured by a numerical rating scale (NRS) from 0 to 10. The investigators research hypothesis is that UTB and CCBPB will result in equivalent postoperative analgesia at 30 minutes in the PACU.
- Conditions
- Shoulder Pain, Phrenic Nerve Paralysis
- Being tested
- Upper trunk block, Costoclavicular block, Diaphragmatic function assessment, Cervical plexus blockade
- Keywords
- bupivacaine, costoclavicular block, upper trunk block
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper trunk blockProcedure or surgery
Also called Upper trunk brachial plexus block
Block will be applied to supraclavicular zone by 20 ml % 0.25 bupivacaine with 5 mcg/ml epinephrine .
Costoclavicular blockProcedure or surgery
Also called Costoclavicular brachial plexus block
Block will be applied to infraclavicular zone by 20 ml % 0.25 bupivacaine with 5 mcg/ml epinephrine.
Diaphragmatic function assessmentProcedure or surgery
Also called Detection of diaphragmatic paralysis with ultrasound guidance
Diaphragmatic excursion will be assessed under ultrasound immediately before and after regional anesthesia.
Cervical plexus blockadeProcedure or surgery
Also called Superficial cervical plexus blockade
Block will be applied at thyroid cartilage level via 10 ml % 0.25 bupivacaine.
| Study group | Role | What they receive |
|---|---|---|
| Upper trunk block | Active comparator | In the supraclavicular region, UTB will be applied with 20 ml % 0.25 bupivacaine with 5 mcg/ml epinephrine. Receives: Procedure: Upper trunk block; Procedure: Diaphragmatic function assessment; Procedure: Cervical plexus blockade |
| Costoclavicular brachial plexus block | Active comparator | In the infraclavicular region, CCBPB will be applied with 20 ml % 0.25 bupivacaine with 5 mcg/ml epinephrine. Receives: Procedure: Costoclavicular block; Procedure: Diaphragmatic function assessment; Procedure: Cervical plexus blockade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of diaphragmatic paralysis by ultrasonography
Ipsilateral diaphragmatic excursion 30 minutes after block completion
Measured: 30 minutes after block application
Secondary outcomes (6)
Postoperative opioid consumption
Total amount of tramadol consumption during the first 24 hours after surgery. Patient controlled analgesia to be inserted.
Measured: 24 hour after surgery
Pain intensity score
Postoperative pain assessed with verbal rating scale (VRS 0: no pain 10:pain as bad as can be )
Measured: 30 minutes, 1,3, 6, 12, 24 hour after surgery
Block perform time
Block application time will be recorded
Measured: The time from the needle enters the skin until the block is completed
Block onset time
Block onset time will be evaluated and recorded.
Measured: Until sensory and motor block occurs
Intraoperative fentanyl requirement
During the operation, 0.5 μg/kg fentanyl was administered to the patient in case of a 20% increase in the mean blood pressure and heart rate compared to the baseline values
Measured: From the beginning to the end of the operation
Patient satisfaction: NRS
Patient satisfaction measured using a NRS 0 to 10 (0 = unsatisfied; 10 =very satisfied)
Measured: 24 hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start10 May 2020
- Primary completionMay 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Serdar Yeşiltaş, Instructor, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194385
- Sponsor's protocol ID
- 71306642-050-05-04-
- Status last verified
- Apr 2023
- First submitted
- 9 Dec 2019
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Perioperative Analgesic Efficacy of Ultrasonography Guided Upper Trunk Block and Costoclavicular Infraclavicular Brachial Plexus Block in Arthroscopic Shoulder Surgery
- ClinicalTrials.gov ID
- NCT04194385
- Acronym / sponsor ID
- 71306642-050-05-04-
- Conditions
- Shoulder Pain, Phrenic Nerve Paralysis
- Keywords
- bupivacaine, costoclavicular block, upper trunk block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 10 May 2020 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 11 Dec 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.
Interscalene brachial plexus block is known as the gold standard for analgesia after shoulder surgery, but limits the use of ipsilateral phrenic nerve paralysis. Recently, interest in potential diaphragm-sparing alternative blocks has increased for patients undergoing shoulder surgery.Two of these blocks are upper trunk block (UTB) and costoclavicular brachial plexus (CCBPB) block. This randomized controlled trial will compare ultrasound-guided UTB and CCBPB in patients undergoing arthroscopic shoulder surgery.
The main outcome is pain intensity score at 30 minutes after arrival in the post anesthesia care unit (PACU) as measured by a numerical rating scale (NRS) from 0 to 10. The investigators research hypothesis is that UTB and CCBPB will result in equivalent postoperative analgesia at 30 minutes in the PACU.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upper trunk block | Active comparator | Procedure: Upper trunk block, Procedure: Diaphragmatic function assessment, Procedure: Cervical plexus blockadeIn the supraclavicular region, UTB will be applied with 20 ml % 0.25 bupivacaine with 5 mcg/ml epinephrine. |
| Costoclavicular brachial plexus block | Active comparator | Procedure: Costoclavicular block, Procedure: Diaphragmatic function assessment, Procedure: Cervical plexus blockadeIn the infraclavicular region, CCBPB will be applied with 20 ml % 0.25 bupivacaine with 5 mcg/ml epinephrine. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Association of Anesthesiologists (ASA) physical status I - III
- BMI 20 to 35 kg / m2
- Patients scheduled for elective arthroscopic shoulder surgery
Key exclusion criteria (13 listed)
- Patients who refuse to participate in the study,
- Pre-existing (obstructive or restrictive) lung disease,
- Coagulopathy,
- Sepsis,
- Hepatic or renal insufficiency,
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 |
|---|---|---|
| Upper trunk blockAlso: Upper trunk brachial plexus blockBlock will be applied to supraclavicular zone by 20 ml % 0.25 bupivacaine with 5 mcg/ml epinephrine . | Procedure or surgery | Upper trunk block |
| Costoclavicular blockAlso: Costoclavicular brachial plexus blockBlock will be applied to infraclavicular zone by 20 ml % 0.25 bupivacaine with 5 mcg/ml epinephrine. | Procedure or surgery | Costoclavicular brachial plexus block |
| Diaphragmatic function assessmentAlso: Detection of diaphragmatic paralysis with ultrasound guidanceDiaphragmatic excursion will be assessed under ultrasound immediately before and after regional anesthesia. | Procedure or surgery | Costoclavicular brachial plexus block, Upper trunk block |
| Cervical plexus blockadeAlso: Superficial cervical plexus blockadeBlock will be applied at thyroid cartilage level via 10 ml % 0.25 bupivacaine. | Procedure or surgery | Costoclavicular brachial plexus block, Upper trunk block |
Primary outcome
Detection of diaphragmatic paralysis by ultrasonography
Time frame: 30 minutes after block application
Ipsilateral diaphragmatic excursion 30 minutes after block completion
6 secondary outcomes
Postoperative opioid consumption
Time frame: 24 hour after surgery
Pain intensity score
Time frame: 30 minutes, 1,3, 6, 12, 24 hour after surgery
Block perform time
Time frame: The time from the needle enters the skin until the block is completed
Block onset time
Time frame: Until sensory and motor block occurs
Intraoperative fentanyl requirement
Time frame: From the beginning to the end of the operation
Patient satisfaction: NRS
Time frame: 24 hour after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
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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.
Serdar Yeşiltaş, Instructor principal investigator
Bezmialem Vakif 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 Upper trunk block, Costoclavicular block and Diaphragmatic function assessment in people with Shoulder Pain and Phrenic Nerve Paralysis, run by Bezmialem Vakif 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 3 inclusion and 13 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 5 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Serdar Yeşiltaş, Instructor (+90 542 363 26 30, syesiltas@bezmialem.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of diaphragmatic paralysis by ultrasonography (time frame: 30 minutes after block application). 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 5 Apr 2023.