Shoulder InjuryISBvsICB-SSBNCT02993939
Interscalene Block Versus Infraclavicular Block Plus Suprascapular Nerve Block
A study testing Interscalene block and Infraclavicular-suprascapular block in people with Shoulder Injury, run by University of Chile at 1 site in Chile.
Trial summary
Despite their reliability and efficacy for shoulder surgery analgesia, above clavicle brachial plexus blocks are related with phrenic nerve palsy and diaphragm paralysis that may not be tolerated in patients with chronic pulmonary disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Shoulder Injury
- What is being tested?
- Interscalene block and Infraclavicular-suprascapular block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChile
- Study dates
- Dec 2016to May 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 18 and 75 years
- American Society of Anesthesiologists classification 1-3
- body mass index between 20 and 30
Who cannot join
- adults who are unable to give their own consent
- pre-existing neuropathy (assessed by history and physical examination)
- coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
- obstructive or restrictive pulmonary disease (assessed by history and physical examination)
- renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
- hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
Show all 10Show fewer
- allergy to local anesthetics (LAs)
- pregnancy
- prior surgery in the neck, infraclavicular region or suprascapular fossa
- chronic pain syndromes requiring opioid intake at home
Trial locations and contacts
1 site in 1 country.
Chile1 site
Hospital Clinico Universidad de Chile
Santiago, Metropolitan, 8380456
About this study
Official title: A Randomized Comparison Between Interscalene Brachial Plexus Block and Combined Infraclavicular Brachial Plexus Block-Suprascapular Nerve Block
Despite their reliability and efficacy for shoulder surgery analgesia, above clavicle brachial plexus blocks are related with phrenic nerve palsy and diaphragm paralysis that may not be tolerated in patients with chronic pulmonary disease.
This RCT will compare the classic Interscalene block with combined infraclavicular block plus suprascapular nerve block in patients going for arthroscopic shoulder surgery.
Main outcome is static pain in the recovery room measured with NRS. Secondary outcomes are pain at 12 and 24 hrs and incidence of diaphragmatic paralysis.
Read the detailed description
PATIENT RECRUITMENT
With the approval of the Ethics Committee of Hospital Clinico Universidad de Chile, 40 patients undergoing arthroscopic shoulder surgery will be recruited. Enrollment will be carried out by an investigator not involved in patient care. Patients' confidentiality will be protected.
STUDY PROTOCOL: GENERAL
All blocks will be performed by one of the coauthors and conducted preoperatively in an induction room. Sedation (2 mg midazolam and 50 μg fentanyl) will be provided for patient comfort.
STUDY PROTOCOL: PERFORMANCE OF THE BLOCK
Both study groups will receive an ultrasound-guided superficial cervical plexus block.
In the ICB-SSB group, suprascapular nerve blocks will be carried out using a previously described technique. For infraclavicular brachial plexus blocks, 20 mL of levobupivacaine 0.25% with epinephrine 5 µg/mL will be injected dorsal to the axillary artery, medial to the coracoid process.
In the ISB group, block will carried out using a previously described technique: 20 mL of levobupivacaine 0.25% with epinephrine 5 µg/mL will be deposited under the prevertebral fascial between the C5 and C6 roots.
STUDY PROTOCOL: GENERAL ANESTHESIA
All patients will undergo standardized general anesthesia
STUDY PROTOCOL: POSTOPERATIVE ANALGESIA
In the Recovery Room, all patients will receive acetaminophen (usual dose…) and ketoprofen (usual dose…) as well as patient controlled analgesia (morphine bolus = 1 mg; lockout interval = 8 minutes). On the surgical ward, all subjects will continue to receive acetaminophen (usual dise…), celecoxib (usual dose…) as well and patient controlled analgesia (morphine bolus = 1 mg IV; lockout interval = 8 minutes).
STUDY PROTOCOL: OUTCOME MEASUREMENTS
The primary outcome will be the pain score in the PACU at 30 30 minutes using a sensorimotor composite scale:
Performance time, sensorimotorSensory function, Onset time
The blinded investigator will also assess the presence of hemidiaphragmatic block at 30 minutes. A 2-6 MHz curvilinear US probe (Sonosite M-Turbo, SonoSite Inc, Bothell, WA, USA) and the M-mode will be employed in all subjects; the liver and spleen will serve as acoustic windows on the right and left side, respectively. Patients will be scanned along the anterior axillary line and the US probe, angled cranially
POTENTIAL BENEFITS OF THE STUDY This study will allow us to determine if ICB-SSB constitutes a viable alternative to ISB.
POTENTIAL SIDE EFFECTS OF THE STUDY Participation in this protocol will not put patients at higher risk for complications since ISB and ICB-SSB are commonly used to provide analgesia for shoulder surgery
- Conditions
- Shoulder Injury
- Being tested
- Interscalene block, Infraclavicular-suprascapular block
- Medical subject headings
- Shoulder Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interscalene blockProcedure or surgery
Ultrasound guided single shot block above the clavicle
Infraclavicular-suprascapular blockProcedure or surgery
Combined block of nerves far away from phrenic nerve
| Study group | Role | What they receive |
|---|---|---|
| Interscalene block | Active comparator | Ultrasound guided Brachial plexus block injecting 20 ml of levobupivacaine 0,25% plus epinephrine 5 micrograms per ml, in the Interscalene groove. Receives: Procedure: Interscalene block |
| Diaphragm-sparing block | Experimental | Ultrasound guided combinated infraclavicular-Suprascapular block of the braquial plexus, injecting 20 ml of levobupivacaine 0,25% plus epinephrine 5 micrograms per ml dorsal to the axillary artery in the infraclavicular fossa plus an Ultrasound guided injection of 10 ml of levobupivacaine 0,25% plus epinephrine 5 micrograms per ml in the suprascapular fossa. Receives: Procedure: Infraclavicular-suprascapular block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static Pain using numeric scale 0-10
Measured: 30 minutes after arrival to PACU
Secondary outcomes (3)
Static Pain using numeric scale 0-10
Measured: 12 hrs after arrival to PACU
Diaphragm paralysis incidence
Measured: 30 minutes after block
Static Pain using numeric scale 0-10
Measured: 24 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2016 (estimated)
- Study startDec 2016
- Primary completion28 Apr 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Shoulder InjuryStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julian Aliste, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02993939
- Sponsor's protocol ID
- 853/16
- Acronym
- ISBvsICB-SSB
- Status last verified
- May 2017
- First submitted
- 12 Dec 2016
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Neal JM, Gerancher JC, Hebl JR, Ilfeld BM, McCartney CJ, Franco CD, Hogan QH. Upper extremity regional anesthesia: essentials of our current understanding, 2008. Reg Anesth Pain Med. 2009 Mar-Apr;34(2):134-70. doi: 10.1097/AAP.0b013e31819624eb.
PubMed 19282714Urmey WF, Talts KH, Sharrock NE. One hundred percent incidence of hemidiaphragmatic paresis associated with interscalene brachial plexus anesthesia as diagnosed by ultrasonography. Anesth Analg. 1991 Apr;72(4):498-503. doi: 10.1213/00000539-199104000-00014.
PubMed 2006740Martinez J, Sala-Blanch X, Ramos I, Gomar C. Combined infraclavicular plexus block with suprascapular nerve block for humeral head surgery in a patient with respiratory failure: an alternative approach. Anesthesiology. 2003 Mar;98(3):784-5. doi: 10.1097/00000542-200303000-00031. No abstract available.
PubMed 12606927Tran DQ, Dugani S, Finlayson RJ. A randomized comparison between ultrasound-guided and landmark-based superficial cervical plexus block. Reg Anesth Pain Med. 2010 Nov-Dec;35(6):539-43. doi: 10.1097/AAP.0b013e3181faa11c.
PubMed 20975470Chan CW, Peng PW. Suprascapular nerve block: a narrative review. Reg Anesth Pain Med. 2011 Jul-Aug;36(4):358-73. doi: 10.1097/AAP.0b013e3182204ec0.
PubMed 21654552Tran DQ, Bertini P, Zaouter C, Munoz L, Finlayson RJ. A prospective, randomized comparison between single- and double-injection ultrasound-guided infraclavicular brachial plexus block. Reg Anesth Pain Med. 2010 Jan-Feb;35(1):16-21. doi: 10.1097/AAP.0b013e3181c7717c.
PubMed 20048654Spence BC, Beach ML, Gallagher JD, Sites BD. Ultrasound-guided interscalene blocks: understanding where to inject the local anaesthetic. Anaesthesia. 2011 Jun;66(6):509-14. doi: 10.1111/j.1365-2044.2011.06712.x.
PubMed 21568985Flohr-Madsen S, Ytrebo LM, Valen K, Wilsgaard T, Klaastad O. A randomised placebo-controlled trial examining the effect on hand supination after the addition of a suprascapular nerve block to infraclavicular brachial plexus blockade. Anaesthesia. 2016 Aug;71(8):938-47. doi: 10.1111/anae.13504.
PubMed 27396247Lloyd T, Tang YM, Benson MD, King S. Diaphragmatic paralysis: the use of M mode ultrasound for diagnosis in adults. Spinal Cord. 2006 Aug;44(8):505-8. doi: 10.1038/sj.sc.3101889. Epub 2005 Dec 6.
PubMed 16331304Dhir S, Sondekoppam RV, Sharma R, Ganapathy S, Athwal GS. A Comparison of Combined Suprascapular and Axillary Nerve Blocks to Interscalene Nerve Block for Analgesia in Arthroscopic Shoulder Surgery: An Equivalence Study. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):564-71. doi: 10.1097/AAP.0000000000000436.
PubMed 27380105Aliste J, Bravo D, Finlayson RJ, Tran DQ. A randomized comparison between interscalene and combined infraclavicular-suprascapular blocks for arthroscopic shoulder surgery. Can J Anaesth. 2018 Mar;65(3):280-287. doi: 10.1007/s12630-017-1048-0. Epub 2017 Dec 19.
PubMed 29270914
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison Between Interscalene Brachial Plexus Block and Combined Infraclavicular Brachial Plexus Block-Suprascapular Nerve Block
- ClinicalTrials.gov ID
- NCT02993939
- Acronym / sponsor ID
- ISBvsICB-SSB / 853/16
- Conditions
- Shoulder Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- 28 Apr 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 15 Dec 2016 (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.
Despite their reliability and efficacy for shoulder surgery analgesia, above clavicle brachial plexus blocks are related with phrenic nerve palsy and diaphragm paralysis that may not be tolerated in patients with chronic pulmonary disease.
This RCT will compare the classic Interscalene block with combined infraclavicular block plus suprascapular nerve block in patients going for arthroscopic shoulder surgery.
Main outcome is static pain in the recovery room measured with NRS. Secondary outcomes are pain at 12 and 24 hrs and incidence of diaphragmatic paralysis.
Detailed description
PATIENT RECRUITMENT
With the approval of the Ethics Committee of Hospital Clinico Universidad de Chile, 40 patients undergoing arthroscopic shoulder surgery will be recruited. Enrollment will be carried out by an investigator not involved in patient care. Patients' confidentiality will be protected.
STUDY PROTOCOL: GENERAL
All blocks will be performed by one of the coauthors and conducted preoperatively in an induction room. Sedation (2 mg midazolam and 50 μg fentanyl) will be provided for patient comfort.
STUDY PROTOCOL: PERFORMANCE OF THE BLOCK
Both study groups will receive an ultrasound-guided superficial cervical plexus block.
In the ICB-SSB group, suprascapular nerve blocks will be carried out using a previously described technique. For infraclavicular brachial plexus blocks, 20 mL of levobupivacaine 0.25% with epinephrine 5 µg/mL will be injected dorsal to the axillary artery, medial to the coracoid process.
In the ISB group, block will carried out using a previously described technique: 20 mL of levobupivacaine 0.25% with epinephrine 5 µg/mL will be deposited under the prevertebral fascial between the C5 and C6 roots.
STUDY PROTOCOL: GENERAL ANESTHESIA
All patients will undergo standardized general anesthesia
STUDY PROTOCOL: POSTOPERATIVE ANALGESIA
In the Recovery Room, all patients will receive acetaminophen (usual dose…) and ketoprofen (usual dose…) as well as patient controlled analgesia (morphine bolus = 1 mg; lockout interval = 8 minutes). On the surgical ward, all subjects will continue to receive acetaminophen (usual dise…), celecoxib (usual dose…) as well and patient controlled analgesia (morphine bolus = 1 mg IV; lockout interval = 8 minutes).
STUDY PROTOCOL: OUTCOME MEASUREMENTS
The primary outcome will be the pain score in the PACU at 30 30 minutes using a sensorimotor composite scale:
Performance time, sensorimotorSensory function, Onset time
The blinded investigator will also assess the presence of hemidiaphragmatic block at 30 minutes. A 2-6 MHz curvilinear US probe (Sonosite M-Turbo, SonoSite Inc, Bothell, WA, USA) and the M-mode will be employed in all subjects; the liver and spleen will serve as acoustic windows on the right and left side, respectively. Patients will be scanned along the anterior axillary line and the US probe, angled cranially
POTENTIAL BENEFITS OF THE STUDY This study will allow us to determine if ICB-SSB constitutes a viable alternative to ISB.
POTENTIAL SIDE EFFECTS OF THE STUDY Participation in this protocol will not put patients at higher risk for complications since ISB and ICB-SSB are commonly used to provide analgesia for shoulder surgery
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interscalene block | Active comparator | Procedure: Interscalene blockUltrasound guided Brachial plexus block injecting 20 ml of levobupivacaine 0,25% plus epinephrine 5 micrograms per ml, in the Interscalene groove. |
| Diaphragm-sparing block | Experimental | Procedure: Infraclavicular-suprascapular blockUltrasound guided combinated infraclavicular-Suprascapular block of the braquial plexus, injecting 20 ml of levobupivacaine 0,25% plus epinephrine 5 micrograms per ml dorsal to the axillary artery in the infraclavicular fossa plus an Ultrasound guided injection of 10 ml of levobupivacaine 0,25% plus epinephrine 5 micrograms per ml in the suprascapular fossa. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age between 18 and 75 years
- American Society of Anesthesiologists classification 1-3
- body mass index between 20 and 30
Key exclusion criteria (10 listed)
- adults who are unable to give their own consent
- pre-existing neuropathy (assessed by history and physical examination)
- coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
- obstructive or restrictive pulmonary disease (assessed by history and physical examination)
- renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
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 single shot block above the clavicle | Procedure or surgery | Interscalene block |
| Infraclavicular-suprascapular blockCombined block of nerves far away from phrenic nerve | Procedure or surgery | Diaphragm-sparing block |
Primary outcome
Static Pain using numeric scale 0-10
Time frame: 30 minutes after arrival to PACU
3 secondary outcomes
Static Pain using numeric scale 0-10
Time frame: 12 hrs after arrival to PACU
Diaphragm paralysis incidence
Time frame: 30 minutes after block
Static Pain using numeric scale 0-10
Time frame: 24 hrs
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 4 May 2017.
- Results publication: PubMed 19282714Neal JM, Gerancher JC, Hebl JR, Ilfeld BM, McCartney CJ, Franco CD, Hogan QH. Upper extremity regional anesthesia: essentials of our current understanding, 2008. Reg Anesth Pain Med. 2009 Mar-Apr;34(2):134-70. doi: 10.1097/AAP.0b013e31819624eb.
- Results publication: PubMed 2006740Urmey WF, Talts KH, Sharrock NE. One hundred percent incidence of hemidiaphragmatic paresis associated with interscalene brachial plexus anesthesia as diagnosed by ultrasonography. Anesth Analg. 1991 Apr;72(4):498-503. doi: 10.1213/00000539-199104000-00014.
- Results publication: PubMed 12606927Martinez J, Sala-Blanch X, Ramos I, Gomar C. Combined infraclavicular plexus block with suprascapular nerve block for humeral head surgery in a patient with respiratory failure: an alternative approach. Anesthesiology. 2003 Mar;98(3):784-5. doi: 10.1097/00000542-200303000-00031. No abstract available.
- Results publication: PubMed 20975470Tran DQ, Dugani S, Finlayson RJ. A randomized comparison between ultrasound-guided and landmark-based superficial cervical plexus block. Reg Anesth Pain Med. 2010 Nov-Dec;35(6):539-43. doi: 10.1097/AAP.0b013e3181faa11c.
- Results publication: PubMed 21654552Chan CW, Peng PW. Suprascapular nerve block: a narrative review. Reg Anesth Pain Med. 2011 Jul-Aug;36(4):358-73. doi: 10.1097/AAP.0b013e3182204ec0.
- Results publication: PubMed 20048654Tran DQ, Bertini P, Zaouter C, Munoz L, Finlayson RJ. A prospective, randomized comparison between single- and double-injection ultrasound-guided infraclavicular brachial plexus block. Reg Anesth Pain Med. 2010 Jan-Feb;35(1):16-21. doi: 10.1097/AAP.0b013e3181c7717c.
- Results publication: PubMed 21568985Spence BC, Beach ML, Gallagher JD, Sites BD. Ultrasound-guided interscalene blocks: understanding where to inject the local anaesthetic. Anaesthesia. 2011 Jun;66(6):509-14. doi: 10.1111/j.1365-2044.2011.06712.x.
- Results publication: PubMed 27396247Flohr-Madsen S, Ytrebo LM, Valen K, Wilsgaard T, Klaastad O. A randomised placebo-controlled trial examining the effect on hand supination after the addition of a suprascapular nerve block to infraclavicular brachial plexus blockade. Anaesthesia. 2016 Aug;71(8):938-47. doi: 10.1111/anae.13504.
- Results publication: PubMed 16331304Lloyd T, Tang YM, Benson MD, King S. Diaphragmatic paralysis: the use of M mode ultrasound for diagnosis in adults. Spinal Cord. 2006 Aug;44(8):505-8. doi: 10.1038/sj.sc.3101889. Epub 2005 Dec 6.
- Results publication: PubMed 27380105Dhir S, Sondekoppam RV, Sharma R, Ganapathy S, Athwal GS. A Comparison of Combined Suprascapular and Axillary Nerve Blocks to Interscalene Nerve Block for Analgesia in Arthroscopic Shoulder Surgery: An Equivalence Study. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):564-71. doi: 10.1097/AAP.0000000000000436.
- Derived from this study: PubMed 29270914Aliste J, Bravo D, Finlayson RJ, Tran DQ. A randomized comparison between interscalene and combined infraclavicular-suprascapular blocks for arthroscopic shoulder surgery. Can J Anaesth. 2018 Mar;65(3):280-287. doi: 10.1007/s12630-017-1048-0. Epub 2017 Dec 19.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interscalene block and Infraclavicular-suprascapular block in people with Shoulder Injury, run by University of Chile at 1 site in Chile.
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 10 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 4 May 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 Chile. 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?
Static Pain using numeric scale 0-10 (time frame: 30 minutes after arrival to PACU). 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 NCT02993939, which also lists 11 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 4 May 2017.