Postoperative PainNCT04446403
Circumflex Nerve Blocks Versus Posterior Cord Nerve Blocks in Shoulder Arthroscopy
A study testing Suprascapular Nerve Block, Axillary Nerve Block and posterior cord block in people with Postoperative Pain, run by Bassant M. Abdelhamid at 1 site in Egypt.
Trial summary
Shoulder arthroscopy is associated with severe postoperative pain. Traditionally, the interscalene approach to the brachial plexus has been employed to manage postoperative pain following shoulder surgery.To provide more complete shoulder joint analgesia, suprascabular nerve block (SSNB) was combined with block of the… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Suprascapular Nerve Block, Axillary Nerve Block and posterior cord block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jun 2020to 30 Sep 2020
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA I-II.-III
- Undergoing shoulder arthroscopy.
Who cannot join
- Patient refusal
- Known allergy to local anesthetics
- Bleeding disorders
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Anesthesia Department
Cairo, 1772
Bassant abdelhamid, 01224254012, bassantmohamed197@yahoo.com
About this study
Official title: Analgesic Effect of Ultrasound Guided Combined (Suprascapular and Circumflex Nerve Blocks ) Versus (Suprascapular Nerve and Posterior Cord Nerve Blocks at Infraclavicular Level ) During Shoulder Arthroscopy : A Randomized Controlled Study
Shoulder arthroscopy is associated with severe postoperative pain. Traditionally, the interscalene approach to the brachial plexus has been employed to manage postoperative pain following shoulder surgery.To provide more complete shoulder joint analgesia, suprascabular nerve block (SSNB) was combined with block of the circumflex nerve which comes from the posterior cord of the brachial plexus that usually gives also upper subscapular, thoracodorsal, lower subscapular and radial nerves.
Read the detailed description
Aim of the work is to compare postoperative analgesic effect of ultrasound guided combined suprascapular and circumflex nerve blocks versus suprascapular nerve and posterior cord blocks at infraclavicular level .
Thirty four patients aged from 18-70 years old, with ASA physical status I-II-III and scheduled for shoulder surgeries will be included in the study. Patients will be randomly allocated using computer-generated table into one of two groups:
- Group circumflex → will undergo ultrasound guided SSN+circumflex.
- Group posterior cord → will undergo ultrasound guided SSN+posterior cord.
- Conditions
- Postoperative Pain
- Being tested
- Suprascapular Nerve Block, Axillary Nerve Block, posterior cord block, General anesthesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suprascapular Nerve BlockProcedure or surgery
Also called SSN
The patient will be put in sitting down position with upper limbs pending beside the body then a high-frequency linear ultrasound probe will be positioned transversely above the spine of the scapula. The suprascapular nerve often appears as hypereccoic structure at the suprascapular notch. A 20-gauge spinal needle will be advanced in-plane from medial to lateral 10mL of bupivacaine 0.25% into the suprascapular notch deep to the superior transverse scapular ligament (STSL) and adjacent to the suprascapular artery (SSA) .
Axillary Nerve BlockProcedure or surgery
Patient will be put in sitting position, with the shoulder in full adduction. linear transducer (8-14 MHz) will be positioned in the short axis orientation at the neck of humerous to identify the axillary artery about 1 to 3 cm from the skin surface.The artery is the most reliable landmark, then a 21-gauge 90 mm needle will be advanced in-plane and 10 mL of bupivacaine 0.25% will be injected adjacent to the artery.
posterior cord blockProcedure or surgery
Patient will be put in supine position with head turned away from side that will be blocked with the arm abducted 90 and flexed at the elbow then linear transducer (8-14 MHz) will be positioned in short-axis just medial to coracoid process.Once the artery will be identified, an attempt will be made to identify the hyperechoic cords of the brachial plexus and their corresponding positions relative to the artery, although these may not always be identifiable. The needle will be inserted in plane from the cephalad end of the probe. 10 mL bupivacaine 0.25% will be injected at the posterior cord.
General anesthesiaProcedure or surgery
General anaesthesia will be induced after giving nerve block in a standardized way with propofol 1.5-2.5mg/kg, fentanyl 2-3 µ/kg and atracurium 0.5mg/kg. maintenance of anaesthesia with isoflurane and atracurium 0.1mg/kg/20min.
| Study group | Role | What they receive |
|---|---|---|
| circumflex | Experimental | patients will undergo ultrasound guided SSN+circumflex Receives: Procedure: Suprascapular Nerve Block; Procedure: Axillary Nerve Block; Procedure: General anesthesia |
| posterior cord | Experimental | patients will undergo ultrasound guided SSN+circumflex Receives: Procedure: Suprascapular Nerve Block; Procedure: posterior cord block; Procedure: General anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of the first postoperative analgesic request
Measured: 12 hours postoperative
Secondary outcomes (2)
Visual analogue score
visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain) and verbal pain scale (VPS )ranging from 0 to 3 (0 = no pain, 1 = mild pain, 2 = moderate pain, and 3 = severe pain).
Measured: 12 hours postoperative
Total morphine consumption
Measured: 12 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start25 Jun 2020
- Primary completion20 Sep 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bassant M. Abdelhamid
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, Bassant M. Abdelhamid, Cairo University
- Investigators
- Mohamed Abd-Elraouf Nasr, Principal investigator, Cairo UniversityAhmed Zaghloul, Study director, Cairo UniversityMohsen Waheb, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04446403
- Sponsor's protocol ID
- S-10-2019
- Status last verified
- Jun 2020
- First submitted
- 22 Jun 2020
- Last updated
- 29 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Axelsson K, Gupta A, Johanzon E, Berg E, Ekback G, Rawal N, Enstrom P, Nordensson U. Intraarticular administration of ketorolac, morphine, and ropivacaine combined with intraarticular patient-controlled regional analgesia for pain relief after shoulder surgery: a randomized, double-blind study. Anesth Analg. 2008 Jan;106(1):328-33, table of contents. doi: 10.1213/01.ane.0000297297.79822.00.
PubMed 18165599Price DJ. The shoulder block: a new alternative to interscalene brachial plexus blockade for the control of postoperative shoulder pain. Anaesth Intensive Care. 2007 Aug;35(4):575-81. doi: 10.1177/0310057X0703500418.
PubMed 18020078Lyons C, Herring AA. Ultrasound-guided axillary nerve block for ED incision and drainage of deltoid abscess. Am J Emerg Med. 2017 Jul;35(7):1032.e3-1032.e7. doi: 10.1016/j.ajem.2017.01.064. Epub 2017 Feb 1.
PubMed 28258838
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of Ultrasound Guided Combined (Suprascapular and Circumflex Nerve Blocks ) Versus (Suprascapular Nerve and Posterior Cord Nerve Blocks at Infraclavicular Level ) During Shoulder Arthroscopy : A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04446403
- Acronym / sponsor ID
- S-10-2019
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Bassant M. AbdelhamidUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 25 Jun 2020 (actual)
- Primary completion
- 20 Sep 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 24 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.
Shoulder arthroscopy is associated with severe postoperative pain. Traditionally, the interscalene approach to the brachial plexus has been employed to manage postoperative pain following shoulder surgery.To provide more complete shoulder joint analgesia, suprascabular nerve block (SSNB) was combined with block of the circumflex nerve which comes from the posterior cord of the brachial plexus that usually gives also upper subscapular, thoracodorsal, lower subscapular and radial nerves.
Detailed description
Aim of the work is to compare postoperative analgesic effect of ultrasound guided combined suprascapular and circumflex nerve blocks versus suprascapular nerve and posterior cord blocks at infraclavicular level .
Thirty four patients aged from 18-70 years old, with ASA physical status I-II-III and scheduled for shoulder surgeries will be included in the study. Patients will be randomly allocated using computer-generated table into one of two groups:
- Group circumflex → will undergo ultrasound guided SSN+circumflex.
- Group posterior cord → will undergo ultrasound guided SSN+posterior cord.
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 |
|---|---|---|
| circumflex | Experimental | Procedure: Suprascapular Nerve Block, Procedure: Axillary Nerve Block, Procedure: General anesthesiapatients will undergo ultrasound guided SSN+circumflex |
| posterior cord | Experimental | Procedure: Suprascapular Nerve Block, Procedure: posterior cord block, Procedure: General anesthesiapatients will undergo ultrasound guided SSN+circumflex |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ASA I-II.-III
- Undergoing shoulder arthroscopy.
Key exclusion criteria (4 listed)
- Patient refusal
- Known allergy to local anesthetics
- Bleeding disorders
- Inability to provide informed consent
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 BlockAlso: SSNThe patient will be put in sitting down position with upper limbs pending beside the body then a high-frequency linear ultrasound probe will be positioned transversely above the spine of the scapula. The suprascapular nerve often appears as hypereccoic structure at the suprascapular notch. A 20-gauge spinal needle will be advanced in-plane from medial to lateral 10mL of bupivacaine 0.25% into the suprascapular notch deep to the superior transverse scapular ligament (STSL) and adjacent to the suprascapular artery (SSA) . | Procedure or surgery | circumflex, posterior cord |
| Axillary Nerve BlockPatient will be put in sitting position, with the shoulder in full adduction. linear transducer (8-14 MHz) will be positioned in the short axis orientation at the neck of humerous to identify the axillary artery about 1 to 3 cm from the skin surface.The artery is the most reliable landmark, then a 21-gauge 90 mm needle will be advanced in-plane and 10 mL of bupivacaine 0.25% will be injected adjacent to the artery. | Procedure or surgery | circumflex |
| posterior cord blockPatient will be put in supine position with head turned away from side that will be blocked with the arm abducted 90 and flexed at the elbow then linear transducer (8-14 MHz) will be positioned in short-axis just medial to coracoid process.Once the artery will be identified, an attempt will be made to identify the hyperechoic cords of the brachial plexus and their corresponding positions relative to the artery, although these may not always be identifiable. The needle will be inserted in plane from the cephalad end of the probe. 10 mL bupivacaine 0.25% will be injected at the posterior cord. | Procedure or surgery | posterior cord |
| General anesthesiaGeneral anaesthesia will be induced after giving nerve block in a standardized way with propofol 1.5-2.5mg/kg, fentanyl 2-3 µ/kg and atracurium 0.5mg/kg. maintenance of anaesthesia with isoflurane and atracurium 0.1mg/kg/20min. | Procedure or surgery | circumflex, posterior cord |
Primary outcome
Time of the first postoperative analgesic request
Time frame: 12 hours postoperative
2 secondary outcomes
Visual analogue score
Time frame: 12 hours postoperative
Total morphine consumption
Time frame: 12 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2020.
- Background: PubMed 18165599Axelsson K, Gupta A, Johanzon E, Berg E, Ekback G, Rawal N, Enstrom P, Nordensson U. Intraarticular administration of ketorolac, morphine, and ropivacaine combined with intraarticular patient-controlled regional analgesia for pain relief after shoulder surgery: a randomized, double-blind study. Anesth Analg. 2008 Jan;106(1):328-33, table of contents. doi: 10.1213/01.ane.0000297297.79822.00.
- Background: PubMed 18020078Price DJ. The shoulder block: a new alternative to interscalene brachial plexus blockade for the control of postoperative shoulder pain. Anaesth Intensive Care. 2007 Aug;35(4):575-81. doi: 10.1177/0310057X0703500418.
- Background: PubMed 28258838Lyons C, Herring AA. Ultrasound-guided axillary nerve block for ED incision and drainage of deltoid abscess. Am J Emerg Med. 2017 Jul;35(7):1032.e3-1032.e7. doi: 10.1016/j.ajem.2017.01.064. Epub 2017 Feb 1.
- 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.
Mohamed Abd-Elraouf Nasr principal investigator
Cairo University
Ahmed Zaghloul study director
Cairo University
Mohsen Waheb study director
Cairo 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, Axillary Nerve Block and posterior cord block in people with Postoperative Pain, run by Bassant M. Abdelhamid 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 2 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 29 Jun 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Zaghloul (002-01001839591, a_zaghloul2000@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of the first postoperative analgesic request (time frame: 12 hours postoperative). 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 NCT04446403, which also lists 3 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 29 Jun 2020.