AnalgesiaNCT06202430
Ultrasound Guided Block for Postoperative Analgesia in Arthroscopic Shoulder Surgery
A study testing High Thoracic Erector Spinae Plane Block and Shoulder Block in people with Analgesia, run by Menoufia University at 1 site in Egypt.
Trial summary
This study aimed to compare the efficacy of high thoracic-ESPB with shoulder block as analgesic options for arthroscopic shoulder surgery. Primary outcome: 24-hour analgesic consumption. Secondary outcomes: Postoperative pain evaluated by: Visual Analogue Pain Scale (VAS). Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Analgesia
- What is being tested?
- High Thoracic Erector Spinae Plane Block and Shoulder Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Aug 2023to 14 Jan 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients within the age range ≥ 21 to ≤ 70 years old.
- Body mass index (BMI) ≤ 35kg m2.
- ASA I, II of both sex
Who cannot join
- Refusal of the patient to the study.
- Infection at the site of injection.
- Previous known allergy to any drug used in the study by history.
- Renal disease [Creatinine. >3mg/dl.].
- Hepatic disease. [ALT>50U/L, AST >50U/L].
- Un cooperative or psychological unstable patients.
- Coagulopathy or anticoagulant therapy.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Ultrasound Guided High Thoracic Erector Spinae Plane Block With Shoulder Block for Postoperative Analgesia in Arthroscopic Shoulder Surgery
This study aimed to compare the efficacy of high thoracic-ESPB with shoulder block as analgesic options for arthroscopic shoulder surgery.
Primary outcome:
- 24-hour analgesic consumption.
Secondary outcomes:
- Postoperative pain evaluated by: Visual Analogue Pain Scale (VAS).
- Time to first rescue analgesia and total postoperative consumption of analgesia.
- Effect of the block on Hemodynamics.
- Adverse effects in the form of postoperative nausea and vomiting (PONV).
- Patient satisfaction.
- Conditions
- Analgesia
- Being tested
- High Thoracic Erector Spinae Plane Block, Shoulder Block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Thoracic Erector Spinae Plane BlockProcedure or surgery
High Thoracic-ESPB The patient was placed in the lateral decubitus. The transverse process of T2 was identified. After negative aspiration, hydro dissection using 2 mL of saline was performed. Eventually, 30 mL of the LA bupivacaine 0.25% and epinephrine 5 µg/ mL was injected.
Shoulder BlockProcedure or surgery
Shoulder Block Suprascapular nerve block (SSNB) approach: The needle was progressed in plane from medial to lateral after local infiltration of the skin with 1% lidocaine. We directed the needle towards the lateral side of the supra-spinous fossa if the neuro-vascular bundle was not evident. After careful aspiration, 10 ml of 0.5% bupivacaine was injected under the supraspinatus muscle.
Axillary nerve block technique:
The nerve approach had been described in plane from cranial to caudal. After local infiltration of the skin with 1% lidocaine, the needle tip must be visualized within the fascia below the teres minor muscle and just above the PCHA. After cautious aspiration, 10 ml of 0.5% bupivacaine was injected on the posterior aspect of the humerus.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Guided High Thoracic Erector Spinae Plane Block | Active comparator | High Thoracic-ESPB The patient was placed in the lateral decubitus. Subsequently, an ultrasound (US)-guided aseptic technique, with a high-frequency linear probe enveloped in a sterile sheath containing a thin film of US gel, was used to locate the transverse process of T2. After LA skin infiltration, a 22-G block was inserted in a cephalocaudal direction until the space between the fascia of the erector spinae and the transverse process of T2 was identified. After negative aspiration, hydro dissection using 2 mL of saline was performed. Eventually, 30 mL of the LA bupivacaine 0.25% and epinephrine 5 µg/ mL was injected. Receives: Procedure: High Thoracic Erector Spinae Plane Block |
| Ultrasound Guided Shoulder Block | Active comparator | Shoulder Block Suprascapular nerve block (SSNB) approach: A high-frequency linear probe was utilized across the supra-spinous fossa parallel to the spine of the scapula after skin cleaning with an antiseptic solution, if a deep block is required, a low frequency probe was required. A hyperechoic line was identified, followed by an acoustic shadow that corresponds to the floor of the supra-spinous fossa. The needle was progressed in plane from medial to lateral after local infiltration of the skin with 1% lidocaine. We directed the needle towards the lateral side of the supra-spinous fossa if the neuro-vascular bundle was not evident. After careful aspiration, 10 ml of 0.5% bupivacaine was injected under the supraspinatus muscle. Along with Axillary nerve block technique. Receives: Procedure: Shoulder Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour analgesic consumption.
Total consumptive dose of Morphine. Patients started acetaminophen (1 g PO) before surgery. Acetaminophen infusion continued postoperatively at a dose of 1 g/6 hours. Later, 75 mg diclofenac sodium was also given intravenously twice a day, in combination with 40 mg pantoprazole once. Rescue analgesia of 2.5 mg morphine was given intravenously if the postoperative Visual Analogue Scale score was > 3 or the patient requested additional analgesia.
Measured: 24 hours.
Secondary outcomes (1)
Visual Analogue Scale.
The pain control target was considered at Visual Analogue Scale score (VAS) < 4, where VAS score of 0 means no pain and VAS score of 10 means the worst pain imaginable. Postoperative pain evaluated by: Visual Analogue Pain Scale (VAS).
Time to first rescue analgesia and total postoperative consumption of analgesia.
Effect of the block on Hemodynamics. Adverse effects in the form of postoperative nausea and vomiting
Measured: ● Every 0.5 hour for next 2 hours. ● Every 2 hours for next 6 hours. ● Every 6 hours for remaining 24 hours post-operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start13 Aug 2023
- Primary completion14 Jan 2024 (estimated)
- Study completion14 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Menoufia 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nevine Mostafa Soliman, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06202430
- Sponsor's protocol ID
- 122023ANET14
- Status last verified
- Jan 2024
- First submitted
- 27 Dec 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound Guided High Thoracic Erector Spinae Plane Block With Shoulder Block for Postoperative Analgesia in Arthroscopic Shoulder Surgery
- ClinicalTrials.gov ID
- NCT06202430
- Acronym / sponsor ID
- 122023ANET14
- Conditions
- Analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 13 Aug 2023 (actual)
- Primary completion
- 14 Jan 2024 (estimated)
- Study completion
- 14 Jan 2024 (estimated)
- First posted
- 11 Jan 2024 (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 aimed to compare the efficacy of high thoracic-ESPB with shoulder block as analgesic options for arthroscopic shoulder surgery.
Primary outcome:
- 24-hour analgesic consumption.
Secondary outcomes:
- Postoperative pain evaluated by: Visual Analogue Pain Scale (VAS).
- Time to first rescue analgesia and total postoperative consumption of analgesia.
- Effect of the block on Hemodynamics.
- Adverse effects in the form of postoperative nausea and vomiting (PONV).
- Patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Guided High Thoracic Erector Spinae Plane Block | Active comparator | Procedure: High Thoracic Erector Spinae Plane BlockHigh Thoracic-ESPB The patient was placed in the lateral decubitus. Subsequently, an ultrasound (US)-guided aseptic technique, with a high-frequency linear probe enveloped in a sterile sheath containing a thin film of US gel, was used to locate the transverse process of T2. After LA skin infiltration, a 22-G block was inserted in a cephalocaudal direction until the space between the fascia of the erector spinae and the transverse process of T2 was identified. After negative aspiration, hydro dissection using 2 mL of saline was performed. Eventually, 30 mL of the LA bupivacaine 0.25% and epinephrine 5 µg/ mL was injected. |
| Ultrasound Guided Shoulder Block | Active comparator | Procedure: Shoulder BlockShoulder Block Suprascapular nerve block (SSNB) approach: A high-frequency linear probe was utilized across the supra-spinous fossa parallel to the spine of the scapula after skin cleaning with an antiseptic solution, if a deep block is required, a low frequency probe was required. A hyperechoic line was identified, followed by an acoustic shadow that corresponds to the floor of the supra-spinous fossa. The needle was progressed in plane from medial to lateral after local infiltration of the skin with 1% lidocaine. We directed the needle towards the lateral side of the supra-spinous fossa if the neuro-vascular bundle was not evident. After careful aspiration, 10 ml of 0.5% bupivacaine was injected under the supraspinatus muscle. Along with Axillary nerve block technique. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients within the age range ≥ 21 to ≤ 70 years old.
- Body mass index (BMI) ≤ 35kg m2.
- ASA I, II of both sex
Key exclusion criteria (8 listed)
- Refusal of the patient to the study.
- Infection at the site of injection.
- Previous known allergy to any drug used in the study by history.
- Renal disease [Creatinine. >3mg/dl.].
- Hepatic disease. [ALT>50U/L, AST >50U/L].
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 |
|---|---|---|
| High Thoracic Erector Spinae Plane BlockHigh Thoracic-ESPB The patient was placed in the lateral decubitus. The transverse process of T2 was identified. After negative aspiration, hydro dissection using 2 mL of saline was performed. Eventually, 30 mL of the LA bupivacaine 0.25% and epinephrine 5 µg/ mL was injected. | Procedure or surgery | Ultrasound Guided High Thoracic Erector Spinae Plane Block |
| Shoulder BlockShoulder Block Suprascapular nerve block (SSNB) approach: The needle was progressed in plane from medial to lateral after local infiltration of the skin with 1% lidocaine. We directed the needle towards the lateral side of the supra-spinous fossa if the neuro-vascular bundle was not evident. After careful aspiration, 10 ml of 0.5% bupivacaine was injected under the supraspinatus muscle. Axillary nerve block technique: The nerve approach had been described in plane from cranial to caudal. After local infiltration of the skin with 1% lidocaine, the needle tip must be visualized within the fascia below the teres minor muscle and just above the PCHA. After cautious aspiration, 10 ml of 0.5% bupivacaine was injected on the posterior aspect of the humerus. | Procedure or surgery | Ultrasound Guided Shoulder Block |
Primary outcome
24-hour analgesic consumption.
Time frame: 24 hours.
Total consumptive dose of Morphine. Patients started acetaminophen (1 g PO) before surgery. Acetaminophen infusion continued postoperatively at a dose of 1 g/6 hours. Later, 75 mg diclofenac sodium was also given intravenously twice a day, in combination with 40 mg pantoprazole once. Rescue analgesia of 2.5 mg morphine was given intravenously if the postoperative Visual Analogue Scale score was > 3 or the patient requested additional analgesia.
1 secondary outcome
Visual Analogue Scale.
Time frame: ● Every 0.5 hour for next 2 hours. ● Every 2 hours for next 6 hours. ● Every 6 hours for remaining 24 hours post-operatively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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 High Thoracic Erector Spinae Plane Block and Shoulder Block in people with Analgesia, run by Menoufia 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 8 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 11 Jan 2024. 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?
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?
24-hour analgesic consumption. (time frame: 24 hours.). 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 11 Jan 2024.