PreoperativeNCT06913140
Preoperative Ultrasound Guided Thoracic Erector Spinae Plane Block Versus Costoclavicular Block for Shoulder Arthroscopy
A study testing Erector Spinae plane Block and Costoclavicular block in people with Preoperative and Ultrasound, run by Tanta University at 1 site in Egypt.
Trial summary
This study was conducted to compare the perioperative analgesic effect of ultrasound guided high thoracic erector spinae plane block versus ultrasound guided costoclavicular block for shoulder arthroscopy Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Preoperative, Ultrasound, Thoracic Erector Spinae Plane Block
- What is being tested?
- Erector Spinae plane Block and Costoclavicular block
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2022to 1 Nov 2024
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 90 patients admitted for elective unilateral shoulder arthroscopy.
- Aged (21 - 65) years.
- American Society of Anesthesiologists (ASA) physical activity I, II
Who cannot join
- Patient refusal.
- Patient with neurological deficit.
- Patient with bleeding disorders (coagulopathy, thrombocytopenia anticoagulant and antiplatelets drugs).
- Uncooperative patient.
- Infection at the block injection site.
- Patients with history of allergy to local anaesthetics
Trial locations and contacts
1 site in 1 country.
About this study
This study was conducted to compare the perioperative analgesic effect of ultrasound guided high thoracic erector spinae plane block versus ultrasound guided costoclavicular block for shoulder arthroscopy
Read the detailed description
Shoulder surgery is one of the most common orthopedic surgical procedures that causes severe pain . Pain management in such patients is very important because pain relief allows early mobilization, effective postoperative rehabilitation, and shorter hospitalization stays. Several regional anesthesia techniques have been used for pain management following shoulder surgery. Interscalene brachial plexus block (ISB) is the gold standard analgesic technique for shoulder procedures, but this method can lead to some serious complications, such as hemidiaphragmatic paralysis (HDP), Horner's syndrome, and hoarseness.
The costoclavicular block (CCB) was introduced as infraclavicular approach, first described in 2015 , targets the brachial plexus in the costoclavicular space where its three cords are tightly clustered together lateral to the axillary artery and more superficially than with the classical approach of infraclavicular fossa . Recently, Garcia-Vittoria et al have suggested that the costoclavicular space could also serve as a retrograde channel to supraclavicular brachial plexus blocks, so if local anesthetic (LA) injected in the costoclavicular space can reliably reach the supraclavicular brachial plexus enabling reliable anesthesia including anesthesia to the suprascapular nerve during shoulder surgery, one could achieve analgesic parity with small-volume supraclavicular block (and ISB) while retaining the 0% incidence of HDP seen with infraclavicular blocks.
Erector spinae plane block (ESPB) is a relatively novel block and was first described for chronic thoracic neuropathic pain in 2016 (. It is an interfascial plane block, but it may be classified as a paraspinal block due to its mechanism of action and injection site
- Conditions
- Preoperative, Ultrasound, Thoracic Erector Spinae Plane Block, Costoclavicular Block, Shoulder Arthroscopy
- Being tested
- Erector Spinae plane Block, Costoclavicular block, Control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae plane BlockDrug
Also called Bupivacaine 0.25%
Patients received (20ml) plain bupivacaine 0.25% injected beneath the erector spinae muscle sheath at the level of the second thoracic segment (T2)
Costoclavicular blockDrug
Also called Bupivacaine 0.25%
Patients received (20ml) plain bupivacaine 0.25% injected in the costoclavicular space lateral to axillary artery.
Control groupDrug
Also called Sham block
Patients received sham block
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae plane Block group | Experimental | Patients received (20ml) plain bupivacaine 0.25% injected beneath the erector spinae muscle sheath at the level of the second thoracic segment (T2) Receives: Drug: Erector Spinae plane Block |
| Costoclavicular block group | Experimental | Patients received (20ml) plain bupivacaine 0.25% injected in the costoclavicular space lateral to axillary artery Receives: Drug: Costoclavicular block |
| Control group | Sham comparator | Patients received sham block . Receives: Drug: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Pethidine consumption
Each patient was instructed about postoperative pain assessment with the Visual Analogue Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable") at (T 30 min, 2, 4, 6,12, 18, 24 h, non-steroidal anti-inflammatory drugs were given (ketorolac 30mg) to all patient /8 h and if VAS > 4 intravenous pethidine 0.5 mg / kg per dose.
Measured: 24 hours postoperatively
Secondary outcomes (3)
Time to first analgesic request after surgery
Time to 1st request for the rescue of analgesia (time from the end of surgery till first dose of morphine administrated) was recorded.
Measured: 24 hours postoperatively
Degree of pain
Each patient was instructed about postoperative pain assessment with the Visual Analogue Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable") at (T 30 min, 2, 4, 6,12, 18, 24 h, non-steroidal anti-inflammatory drugs were given (ketorolac 30mg) to all patient /8 h and if VAS > 4 intravenous pethidine 0.5 mg / kg per dose.
Measured: 24 hours postoperatively
Complications
Complications (Hematoma, pneumothorax, persistent numbness/ paraesthesia or motor deficit one week after the surgery) were recorded.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start1 Dec 2022
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreoperativeStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Gamal Naeem, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06913140
- Sponsor's protocol ID
- 35844/9/22
- Status last verified
- Apr 2025
- First submitted
- 29 Mar 2025
- Last updated
- 25 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Ultrasound Guided Thoracic Erector Spinae Plane Block Versus Costoclavicular Block for Shoulder Arthroscopy
- ClinicalTrials.gov ID
- NCT06913140
- Acronym / sponsor ID
- 35844/9/22
- Conditions
- Preoperative, Ultrasound, Thoracic Erector Spinae Plane Block, Costoclavicular Block, Shoulder Arthroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 6 Apr 2025 (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.
This study was conducted to compare the perioperative analgesic effect of ultrasound guided high thoracic erector spinae plane block versus ultrasound guided costoclavicular block for shoulder arthroscopy
Detailed description
Shoulder surgery is one of the most common orthopedic surgical procedures that causes severe pain . Pain management in such patients is very important because pain relief allows early mobilization, effective postoperative rehabilitation, and shorter hospitalization stays. Several regional anesthesia techniques have been used for pain management following shoulder surgery. Interscalene brachial plexus block (ISB) is the gold standard analgesic technique for shoulder procedures, but this method can lead to some serious complications, such as hemidiaphragmatic paralysis (HDP), Horner's syndrome, and hoarseness.
The costoclavicular block (CCB) was introduced as infraclavicular approach, first described in 2015 , targets the brachial plexus in the costoclavicular space where its three cords are tightly clustered together lateral to the axillary artery and more superficially than with the classical approach of infraclavicular fossa . Recently, Garcia-Vittoria et al have suggested that the costoclavicular space could also serve as a retrograde channel to supraclavicular brachial plexus blocks, so if local anesthetic (LA) injected in the costoclavicular space can reliably reach the supraclavicular brachial plexus enabling reliable anesthesia including anesthesia to the suprascapular nerve during shoulder surgery, one could achieve analgesic parity with small-volume supraclavicular block (and ISB) while retaining the 0% incidence of HDP seen with infraclavicular blocks.
Erector spinae plane block (ESPB) is a relatively novel block and was first described for chronic thoracic neuropathic pain in 2016 (. It is an interfascial plane block, but it may be classified as a paraspinal block due to its mechanism of action and injection site
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae plane Block group | Experimental | Drug: Erector Spinae plane BlockPatients received (20ml) plain bupivacaine 0.25% injected beneath the erector spinae muscle sheath at the level of the second thoracic segment (T2) |
| Costoclavicular block group | Experimental | Drug: Costoclavicular blockPatients received (20ml) plain bupivacaine 0.25% injected in the costoclavicular space lateral to axillary artery |
| Control group | Sham comparator | Drug: Control groupPatients received sham block . |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 90 patients admitted for elective unilateral shoulder arthroscopy.
- Aged (21 - 65) years.
- American Society of Anesthesiologists (ASA) physical activity I, II
Key exclusion criteria (6 listed)
- Patient refusal.
- Patient with neurological deficit.
- Patient with bleeding disorders (coagulopathy, thrombocytopenia anticoagulant and antiplatelets drugs).
- Uncooperative patient.
- Infection at the block injection site.
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 |
|---|---|---|
| Erector Spinae plane BlockAlso: Bupivacaine 0.25%Patients received (20ml) plain bupivacaine 0.25% injected beneath the erector spinae muscle sheath at the level of the second thoracic segment (T2) | Drug | Erector Spinae plane Block group |
| Costoclavicular blockAlso: Bupivacaine 0.25%Patients received (20ml) plain bupivacaine 0.25% injected in the costoclavicular space lateral to axillary artery. | Drug | Costoclavicular block group |
| Control groupAlso: Sham blockPatients received sham block | Drug | Control group |
Primary outcome
Total Pethidine consumption
Time frame: 24 hours postoperatively
Each patient was instructed about postoperative pain assessment with the Visual Analogue Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable") at (T 30 min, 2, 4, 6,12, 18, 24 h, non-steroidal anti-inflammatory drugs were given (ketorolac 30mg) to all patient /8 h and if VAS > 4 intravenous pethidine 0.5 mg / kg per dose.
3 secondary outcomes
Time to first analgesic request after surgery
Time frame: 24 hours postoperatively
Degree of pain
Time frame: 24 hours postoperatively
Complications
Time frame: 24 hours postoperatively
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 25 Apr 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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 Erector Spinae plane Block and Costoclavicular block in people with Preoperative and Ultrasound, run by Tanta 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 6 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 25 Apr 2025. 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. Some participants in this study may receive a placebo. 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?
Total Pethidine consumption (time frame: 24 hours postoperatively). 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 25 Apr 2025.