Shoulder SurgeryNCT04224766
Comparison Between Interscalene and Combined Costoclavicular-suprascapular Blocks for Arthroscopic Shoulder Surgery
A study testing Suprascapular Nerve Block with 5ml bupivicaine 0.5%, costoclavicular Block 10ml bupivicaine 0.5% and Interscalene Brachial Plexus Block 15ml bupivicaine 0.5% in people with Shoulder Surgery and Regional Anesthesia Morbidity, run by Assiut University at 1 site in Egypt.
Trial summary
Postoperative analgesia for shoulder surgery is typically achieved by providing an interscalene brachial plexus block. However, a very common side effect of this block is hemi-diaphragmatic paralysis, a state which may not be tolerated in patients with pulmonary conditions such as COPD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Surgery, Regional Anesthesia Morbidity
- What is being tested?
- Suprascapular Nerve Block with 5ml bupivicaine 0.5%, costoclavicular Block 10ml bupivicaine 0.5% and Interscalene Brachial Plexus Block 15ml bupivicaine 0.5%
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2020to 1 Feb 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA status 1,2,3.
- Age 18 years or older
- Elective shoulder arthroscopic surgery under general anesthesia and nerve block performed preoperatively
Who cannot join
- Serious cardiac arrhythmias (including atrial fibrillation) or unstable coronary artery disease.
- Coagulation disorders.
- Patient refusal.
- Anatomical disorders and/or neuropathic disease.
- BMI above 40.
- History of substance abuse.
Show all 11Show fewer
- Chronic use of psychotropic and/or opioid.
- History of psychiatric diseases needing treatment.
- Contraindications to nerve block for shoulder surgery.
- Allergy to fentanil or any drug in the study protocol.
- Failure of nerve block
Trial locations and contacts
1 site in 1 country.
About this study
Postoperative analgesia for shoulder surgery is typically achieved by providing an interscalene brachial plexus block. However, a very common side effect of this block is hemi-diaphragmatic paralysis, a state which may not be tolerated in patients with pulmonary conditions such as COPD. Recently, clinicians have explored new ways to provide satisfactory analgesia while minimizing the pulmonary side effects of the interscalene nerve block. One of these solutions might be to offer the patient a suprascapular nerve block combined to a costoclavicular block. Since these blocks are performed lower in the neck or under the clavicle, the phrenic nerve is less likely to be blocked. Thus, fewer respiratory side effects have been reported when using such blocks. This prospective observational study will evaluate the patient response to surgical stimuli and the opioid requirements intraoperatively in patients undergoing shoulder arthroscopies with either a supraclavicular and costoclavicular blocks or an interscalene block.
Study Design: Prospective, randomized open label non-inferiority trial. Subject Population: Adults scheduled to undergo elective shoulder arthroscopy Sample Size: 50 patients Study Duration: Starts February 2020 - Ends February 2021 - Interim analysis at 30 patients Study Center: Assuit university hospital
Read the detailed description
The main hypothesis of this study is that the suprascapular block combined with a costoclavicular block is not inferior to the interscalene brachial plexus block in terms of postoperative analgesia. Inverstigators postulate that postoperative pain score will not differ significantly in patients who receive either block.
secondary objectives will consist in looking at the differences in intraoperative anesthetic consumption, postoperative opioid consumption, arm motor block, diaphragmatic paresis, patient satisfaction and time for readiness to discharge from PACU. investigators hypothesize that these outcomes will be similar in both groups, with the exception of a potential reduction in arm motor block and diaphragmatic paresis in the combined suprascapular and costoclavicular block group.
After having obtained institutional ethics board approval of the study, patients older than 18 years old, scheduled for a first elective shoulder arthroscopy under general anesthesia will be screened in the pre-anesthesia clinic. patients will be approached and the whole study procedures will be explained extensively. Interested patients will be invited to sign the consent form .Patients will have the right to opt out at any time. The investigators will meet the patients again on the morning of the surgery to address any concerns. After consent, a study number will be allocated to the patient in ascending order.
Two groups will be evaluated:
- Group A: single shot US-guided suprascapular nerve block with 5 mL bupivacaine 0.5%, then single shot US-guided costoclavicular block with 10 ml bupivacaine 0.5%.
- Group B: single shot US-guided interscalene brachial plexus block with 15 mL bupivacaine 0.5%.
Tests will be done to evaluate the nerve block-induced loss of sensation to ice prior to entering the operating room (OR). Diaphragmatic excursion will be evaluated using an abdominal curvilinear ultrasound probe, and will be classified as being normal, paradoxical or immobile. Normal motion is caudad movement during inspiration. Paradoxical motion is cephalad movement during inspiration.
Once in the operating room, all routine monitors are connected.. Both study monitors are switched on and will record their respective indices continuously for the duration of the anesthesia. General anesthesia will be induced with propofol (1-2 mg/kg IV), fentanil (1 µg/kg IV bolus) and cis-atracium (0.1-0.2 mg/kg IV; ). A bolus of dexamethasone 4mg IV will be administered after induction of general anesthesia.
Patients will also have received oral acetaminophen 1g preoperatively. Intubation with an endotracheal tube is performed once the patient is adequately paralyzed . All drugs are given according to the adjusted body weight of the patient. This is calculated with Robinson's formula: where TBW is total body weight and IBW is ideal body weight (21-22). Immediately after intubation, anesthesia is maintained with isoflurane . At the end of anesthesia, Emergence and extubation are done in the OR. All times (start skin closure, start dressing, stop isoflurane) will be precisely reported in the CRF.
- Conditions
- Shoulder Surgery, Regional Anesthesia Morbidity
- Being tested
- Suprascapular Nerve Block with 5ml bupivicaine 0.5%, costoclavicular Block 10ml bupivicaine 0.5%, Interscalene Brachial Plexus Block 15ml bupivicaine 0.5%
- Keywords
- regional anesthesia, interscalene brachial plexus block, suprascapular and costoclavicular blocks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suprascapular Nerve Block with 5ml bupivicaine 0.5%Procedure or surgery
Also called SSNB
The patient lies supine with the head turned to the contralateral side to the block. Using a linear high-frequency ultrasound probe, the proximal suprascapular nerve is visualized before it turns toward the suprascapular notch. It is blocked using 5mL of bupivicaine 0.5%.
costoclavicular Block 10ml bupivicaine 0.5%Procedure or surgery
Also called CCB
transverse ultrasound imaging of the medial infraclavicular fossa to identify the cords of the brachial plexus at the costoclavicular space (CCS) then inject 10ml bupivicaine 0.5%
Interscalene Brachial Plexus Block 15ml bupivicaine 0.5%Procedure or surgery
Also called ISBP
The patient lies supine with the head turned to the contralateral side to the block. Using a linear high-frequency ultrasound probe, the interscalene groove is visualized along with the roots of the brachial plexus. The block is performed with 15mL of bupivacaine 0.5%.
| Study group | Role | What they receive |
|---|---|---|
| suprascapular nerve block with costoclavicular infraclavicular | Experimental | Single shot US-guided suprascapular nerve block (SSNB) with 5 mL bupivacaine 0.5%, then single shot US-guided costoclavicular block (CCB) with 10 ml bupivacaine 0.5%. Receives: Procedure: Suprascapular Nerve Block with 5ml bupivicaine 0.5%; Procedure: costoclavicular Block 10ml bupivicaine 0.5% |
| Interscalene brachial plexus block | Active comparator | Single shot US-guided interscalene brachial plexus block (ISBPB) with 15 mL bupivacaine 0.5%. Receives: Procedure: Interscalene Brachial Plexus Block 15ml bupivicaine 0.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain scores on a scale from 0 to 10
PACU pain score from 1 to 10 which 1 indicate no pain and 10 maximum pain.
Measured: From entrance in PACU until PACU discharge e.g. up to 3 hours after surgery maximum
naluphine consumption postoperative
use of naluphine for postoperative analgesia in mg by asking PACU nurse questionnaire
Measured: 2 hours postoperative
Secondary outcomes (7)
Total dose fentanil in mcg
Total dose of fentanil in mcg from incision until wound dressing
Measured: Intraoperative
Time to awakening in minutes
Time to awakening in minutes.
Measured: Intraoperative
Time to extubation in minutes
Time to extubation in minutes.
Measured: Intraoperative
Patient dyspnea on a scale from 0 to 10 in dyspnea scale
Patient dyspnea prior to PACU discharge on a scale from 0 to 10.
Measured: PACU e.g. up to 3 hours after surgery maximum
24h pain scores on a scale from 0 to 10 at rest (NPS)
24h pain scores, H24
Measured: Postoperative at H24, 24 hours after surgery
Duration of motor block in minutes strength
Duration of motor block in minutes, as measured by time to return of normal grip strength.
Measured: Postoperative for day 1 H24 24hours after surgery
TIME OF 1ST RESCUE ANALGESIC
time of 1st dose of naluphine use postoperative
Measured: 24 hour postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start1 Apr 2020
- Primary completion1 Jan 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder SurgeryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Model description
- 2 groups of patients. Randomization into groups SSNP + costoclavicular or ISBPB as per randomization list, for a total of 50 patients.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamed talaat mohamed mohamed, Assiut University
- Investigators
- mohamed talaat mohamed, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04224766
- Sponsor's protocol ID
- 17200124
- Status last verified
- Mar 2022
- First submitted
- 6 Jan 2020
- Last updated
- 1 Apr 2022
- 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 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Interscalene and Combined Costoclavicular-suprascapular Blocks for Arthroscopic Shoulder Surgery
- ClinicalTrials.gov ID
- NCT04224766
- Acronym / sponsor ID
- 17200124
- Conditions
- Shoulder Surgery, Regional Anesthesia Morbidity
- Keywords
- regional anesthesia, interscalene brachial plexus block, suprascapular and costoclavicular blocks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 13 Jan 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.
Postoperative analgesia for shoulder surgery is typically achieved by providing an interscalene brachial plexus block. However, a very common side effect of this block is hemi-diaphragmatic paralysis, a state which may not be tolerated in patients with pulmonary conditions such as COPD. Recently, clinicians have explored new ways to provide satisfactory analgesia while minimizing the pulmonary side effects of the interscalene nerve block. One of these solutions might be to offer the patient a suprascapular nerve block combined to a costoclavicular block. Since these blocks are performed lower in the neck or under the clavicle, the phrenic nerve is less likely to be blocked. Thus, fewer respiratory side effects have been reported when using such blocks. This prospective observational study will evaluate the patient response to surgical stimuli and the opioid requirements intraoperatively in patients undergoing shoulder arthroscopies with either a supraclavicular and costoclavicular blocks or an interscalene block.
Study Design: Prospective, randomized open label non-inferiority trial. Subject Population: Adults scheduled to undergo elective shoulder arthroscopy Sample Size: 50 patients Study Duration: Starts February 2020 - Ends February 2021 - Interim analysis at 30 patients Study Center: Assuit university hospital
Detailed description
The main hypothesis of this study is that the suprascapular block combined with a costoclavicular block is not inferior to the interscalene brachial plexus block in terms of postoperative analgesia. Inverstigators postulate that postoperative pain score will not differ significantly in patients who receive either block.
secondary objectives will consist in looking at the differences in intraoperative anesthetic consumption, postoperative opioid consumption, arm motor block, diaphragmatic paresis, patient satisfaction and time for readiness to discharge from PACU. investigators hypothesize that these outcomes will be similar in both groups, with the exception of a potential reduction in arm motor block and diaphragmatic paresis in the combined suprascapular and costoclavicular block group.
After having obtained institutional ethics board approval of the study, patients older than 18 years old, scheduled for a first elective shoulder arthroscopy under general anesthesia will be screened in the pre-anesthesia clinic. patients will be approached and the whole study procedures will be explained extensively. Interested patients will be invited to sign the consent form .Patients will have the right to opt out at any time. The investigators will meet the patients again on the morning of the surgery to address any concerns. After consent, a study number will be allocated to the patient in ascending order.
Two groups will be evaluated:
- Group A: single shot US-guided suprascapular nerve block with 5 mL bupivacaine 0.5%, then single shot US-guided costoclavicular block with 10 ml bupivacaine 0.5%.
- Group B: single shot US-guided interscalene brachial plexus block with 15 mL bupivacaine 0.5%.
Tests will be done to evaluate the nerve block-induced loss of sensation to ice prior to entering the operating room (OR). Diaphragmatic excursion will be evaluated using an abdominal curvilinear ultrasound probe, and will be classified as being normal, paradoxical or immobile. Normal motion is caudad movement during inspiration. Paradoxical motion is cephalad movement during inspiration.
Once in the operating room, all routine monitors are connected.. Both study monitors are switched on and will record their respective indices continuously for the duration of the anesthesia. General anesthesia will be induced with propofol (1-2 mg/kg IV), fentanil (1 µg/kg IV bolus) and cis-atracium (0.1-0.2 mg/kg IV; ). A bolus of dexamethasone 4mg IV will be administered after induction of general anesthesia.
Patients will also have received oral acetaminophen 1g preoperatively. Intubation with an endotracheal tube is performed once the patient is adequately paralyzed . All drugs are given according to the adjusted body weight of the patient. This is calculated with Robinson's formula: where TBW is total body weight and IBW is ideal body weight (21-22). Immediately after intubation, anesthesia is maintained with isoflurane . At the end of anesthesia, Emergence and extubation are done in the OR. All times (start skin closure, start dressing, stop isoflurane) will be precisely reported in the CRF.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 2 groups of patients. Randomization into groups SSNP + costoclavicular or ISBPB as per randomization list, for a total of 50 patients.
| Arm | Type | Receives |
|---|---|---|
| suprascapular nerve block with costoclavicular infraclavicular | Experimental | Procedure: Suprascapular Nerve Block with 5ml bupivicaine 0.5%, Procedure: costoclavicular Block 10ml bupivicaine 0.5%Single shot US-guided suprascapular nerve block (SSNB) with 5 mL bupivacaine 0.5%, then single shot US-guided costoclavicular block (CCB) with 10 ml bupivacaine 0.5%. |
| Interscalene brachial plexus block | Active comparator | Procedure: Interscalene Brachial Plexus Block 15ml bupivicaine 0.5%Single shot US-guided interscalene brachial plexus block (ISBPB) with 15 mL bupivacaine 0.5%. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA status 1,2,3.
- Age 18 years or older
- Elective shoulder arthroscopic surgery under general anesthesia and nerve block performed preoperatively
Key exclusion criteria (11 listed)
- Serious cardiac arrhythmias (including atrial fibrillation) or unstable coronary artery disease.
- Coagulation disorders.
- Patient refusal.
- Anatomical disorders and/or neuropathic disease.
- BMI above 40.
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 |
|---|---|---|
| Suprascapular Nerve Block with 5ml bupivicaine 0.5%Also: SSNBThe patient lies supine with the head turned to the contralateral side to the block. Using a linear high-frequency ultrasound probe, the proximal suprascapular nerve is visualized before it turns toward the suprascapular notch. It is blocked using 5mL of bupivicaine 0.5%. | Procedure or surgery | suprascapular nerve block with costoclavicular infraclavicular |
| costoclavicular Block 10ml bupivicaine 0.5%Also: CCBtransverse ultrasound imaging of the medial infraclavicular fossa to identify the cords of the brachial plexus at the costoclavicular space (CCS) then inject 10ml bupivicaine 0.5% | Procedure or surgery | suprascapular nerve block with costoclavicular infraclavicular |
| Interscalene Brachial Plexus Block 15ml bupivicaine 0.5%Also: ISBPThe patient lies supine with the head turned to the contralateral side to the block. Using a linear high-frequency ultrasound probe, the interscalene groove is visualized along with the roots of the brachial plexus. The block is performed with 15mL of bupivacaine 0.5%. | Procedure or surgery | Interscalene brachial plexus block |
Primary outcome
pain scores on a scale from 0 to 10
Time frame: From entrance in PACU until PACU discharge e.g. up to 3 hours after surgery maximum
PACU pain score from 1 to 10 which 1 indicate no pain and 10 maximum pain.
naluphine consumption postoperative
Time frame: 2 hours postoperative
use of naluphine for postoperative analgesia in mg by asking PACU nurse questionnaire
7 secondary outcomes
Total dose fentanil in mcg
Time frame: Intraoperative
Time to awakening in minutes
Time frame: Intraoperative
Time to extubation in minutes
Time frame: Intraoperative
Patient dyspnea on a scale from 0 to 10 in dyspnea scale
Time frame: PACU e.g. up to 3 hours after surgery maximum
24h pain scores on a scale from 0 to 10 at rest (NPS)
Time frame: Postoperative at H24, 24 hours after surgery
Duration of motor block in minutes strength
Time frame: Postoperative for day 1 H24 24hours after surgery
TIME OF 1ST RESCUE ANALGESIC
Time frame: 24 hour postoperative
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 1 Apr 2022.
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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.
mohamed talaat mohamed, MD principal investigator
Assiut 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 Suprascapular Nerve Block with 5ml bupivicaine 0.5%, costoclavicular Block 10ml bupivicaine 0.5% and Interscalene Brachial Plexus Block 15ml bupivicaine 0.5% in people with Shoulder Surgery and Regional Anesthesia Morbidity, run by Assiut University at 1 site in Egypt.
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: finished, as of the sponsor's last update on 1 Apr 2022. 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 Egypt. 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?
pain scores on a scale from 0 to 10 (time frame: From entrance in PACU until PACU discharge e.g. up to 3 hours after surgery maximum). The study lists 2 primary outcomes in all. 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 1 Apr 2022.