Post Operative PainNCT05791058
Post-Operative Analgesic Efficacy Of Ultrasound Guided Pericapsular Nerve Group Block Versus Combined Suprascapular And Axillary (Circumflex) Nerve Block For Patients Undergoing Shoulder Arthroscopy
A study testing ultrasound guided pericapsular nerve group shoulder block, ultrasound guided suprascapular and axillary nerve block and general anesthesia without nerve block in people with Post Operative Pain, run by Ain Shams University.
Trial summary
Recently, the Combined suprascapular nerve block and axillary nerve block (SSNB+ANB) was proposed to provide anesthesia and postoperative analgesia for shoulder surgery as a safe alternative to interscalene block. These two peripheral nerves are responsible for the majority of the sensory innervation of the shoulder. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- ultrasound guided pericapsular nerve group shoulder block, ultrasound guided suprascapular and axillary nerve block and general anesthesia without nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2023to 20 May 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults between age of 18 and 60 years old undergoing elective shoulder arthroscopy surgery.
- American society of anesthesiologists classification (ASA) Ⅰ\&Ⅱ
- Males \& Females
Who cannot join
- Age: < 18 or > 60 years old.
- Patients refuse to participate in the study.
- Patients with known hypersensitivity to local anesthetics.
- Coagulation disorder
- Infection at the site of injection
- Hepatic impairment
- Renal impairment
- Severe intraoperative bleeding affecting the hemodynamics status of the patient.
About this study
Official title: Post-Operative Analgesic Efficacy Of Ultrasound Guided Pericapsular Nerve Group Block Versus Combined Suprascapular And Axillary (Circumflex) Nerve Block For Patients Undergoing Shoulder Arthroscopy: A Randomized Controlled Trial
Recently, the Combined suprascapular nerve block and axillary nerve block (SSNB+ANB) was proposed to provide anesthesia and postoperative analgesia for shoulder surgery as a safe alternative to interscalene block. These two peripheral nerves are responsible for the majority of the sensory innervation of the shoulder.
PENG block has been studied extensively in hip surgeries, but its place in shoulder surgeries is not yet clear. It is a new technology reported for block of articular branches of the shoulder and well pericapsular spread around the glenohumeral joint Therefore, achieving pain relief while avoiding motor block allows us not only to provide an early rehabilitation program in the postoperative period, but also to control the chronic nociceptive activation secondary to pain-induced movement
Read the detailed description
Preoperative:
Routine preoperative assessment will be done before operation to all patients including history, clinical examination and laboratory investigations (complete blood picture, kidney function tests, liver function tests, pro-thrombin time, and partial thromboplastin time). Chest X-ray, electrocardiogram [ECG] will be done for patients above 40 years old.
All patients will be informed about the study design and objectives as well as tools and techniques. Informed consent will be signed by every patient prior to inclusion in the study.
All patients will be informed about the analgesic regimen and will be instructed on how to express pain intensity with use of the visual analogue scale (VAS) (10cm unmarked line in which 0=no pain, 10cm=the worst imaginable pain)
Anesthetic techniques:
- General Anesthesia Technique: Pre-medications will be given to every patient of the two including groups in the form of midazolam (0.05 mg/kg, IV) together with omeprazole (40 mg, IV) and ondansetron (4 mg, IV) on arrival to the operative room after establishing a peripheral intravenous access. Vital signs will be continuously monitored. After pre-oxygenation for 3 minutes, general anesthesia is induced to all patients with fentanyl (1-2 μg/kg, IV), propofol (1-2mg/Kg, IV), and atracurium (0.5mg/Kg, IV) to facilitate endotracheal intubation. Intermittent positive pressure ventilation of both lungs will be applied (to maintain O2 saturation >98% and end tidal carbon dioxide measurement around 35-38 mmHg). Maintenance of anesthesia will be achieved using intermittent positive pressure ventilation with inhalation of 1-1.5% isoflurane in 50% O2 and atracurium (0.1mg/Kg, IV) every 30 minutes to maintain muscle relaxation.
- Ultrasound guided PENG shoulder block Technique (Group A): The patient's arm is placed in external rotation and abducted at 45 degrees. A linear ultrasound probe will be placed longitudinally between the coracoid and the humeral head. After defining the humeral head, the tendon of the subscapular muscle and the deltoid muscle over it, a 50-mm needle will be inserted using the ''in plane'' technique. When the needle pass through the deltoid muscle and touched the subscapularis tendon, a bone-like hard tissue will be felt and the needle could not be advanced further. The needle tip will be placed between the deltoid muscle and subscapularis tendon, and 20 cc of 0.25% bupivacaine hydrochloride with 4mg dexamesathone will be injected.
- Ultrasound guided combined suprascapular nerve block and axillary nerve block (SSNB+ANB) Technique (Group B):
The ultrasound guided suprascapular nerve block:
The patient will be positioned in a semi-recumbent position with the operating arm on the contralateral shoulder. The probe will be kept over the scapular spine to identify the trapezius and the supraspinatus muscle. Then, it will be moved laterally to identify the concavity of the supraspinatus fossa and the hyper-echoic fascia of the supraspinatus muscle. In the concavity of the fossa, the suprascapular artery and the suprascapular nerve run in close proximity. 10 ml of 0.25% bupivacaine with 2mg dexamethasone will be injected below the supraspinatus fascia.
The ultrasound guided axillary nerve block:
The patients is positioned in a semi-recumbent position with the arm slightly flexed and adducted at the elbow. The posterior surface of the humerus will be visualised in the short axis view. So, the AN and posterior circumflex artery will be visualised longitudinally. 10 ml of 0.25% bupivacaine with 2mg dexamethasone will be injected into space.
The blocks will be considered a failed block if the block is not successful 30 min after the injection of the local anaesthetic.
Group A 20 Patients of this group will receive ultrasound guided pericapsular nerve group shoulder block (PENG Block) at the end of surgery using 20 ml of 0.25% bupivacaine with 4mg dexamethasone with a maximum dose of (3mg/kg).
Group B 20 Patients of this group will receive single shot suprascapular and axillary nerve using a single dose of 10ml of 0.25% bupivacaine with 2mg dexamethasone each at the end of surgery for postoperative pain relief.
Group C 20 patients of this group will receive general anesthesia without nerve block. In the post anesthesia care unit (PACU) for first hour and in ward afterwards , all patients will be assessed for presence and severity of pain at at 1, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours postoperatively or at any time patient suffers from pain with visual analog score and recording its value at any patient visit.
Nalbuphine 0.1 mg/kg is the rescue analgesic that will be given to any patient who will suffer pain with VAS more than 3.
- Conditions
- Post Operative Pain
- Being tested
- ultrasound guided pericapsular nerve group shoulder block, ultrasound guided suprascapular and axillary nerve block, general anesthesia without nerve block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided pericapsular nerve group shoulder blockProcedure or surgery
The patient's arm is placed in external rotation and abducted at 45 degrees. A linear ultrasound probe will be placed longitudinally between the coracoid and the humeral head. After defining the humeral head, the tendon of the subscapular muscle and the deltoid muscle over it, a 50-mm needle will be inserted using the ''in plane'' technique. When the needle pass through the deltoid muscle and touched the subscapularis tendon, a bone-like hard tissue will be felt and the needle could not be advanced further. The needle tip will be placed between the deltoid muscle and subscapularis tendon, and 20 cc of 0.25% bupivacaine hydrochloride with 4mg dexamesathone will be injected
ultrasound guided suprascapular and axillary nerve blockProcedure or surgery
The patient will be positioned in a semi-recumbent position with the operating arm on the contralateral shoulder. The probe will be kept over the scapular spine to identify the trapezius and the supraspinatus muscle. Then, it will be moved laterally to identify the concavity of the supraspinatus fossa and the hyper-echoic fascia of the supraspinatus muscle. In the concavity of the fossa, the suprascapular artery and the suprascapular nerve run in close proximity. 10 ml of 0.25% bupivacaine with 2mg dexamethasone will be injected below the supraspinatous fascia then the posterior surface of the humerus will be visualised in the short axis view. So, the AN and posterior circumflex artery will be visualised longitudinally. 10 ml of 0.25% bupivacaine with 2mg dexamethasone will be injected into space
general anesthesia without nerve blockOther
this group will receive general anesthesia without nerve block
| Study group | Role | What they receive |
|---|---|---|
| Group A (ultrasound guided pericapsular nerve group shoulder block) | Active comparator | Not described Receives: Procedure: ultrasound guided pericapsular nerve group shoulder block |
| Group B( ultrasound guided suprascapular and axillary nerve block) | Active comparator | Not described Receives: Procedure: ultrasound guided suprascapular and axillary nerve block |
| control group | Active comparator | Not described Receives: Other: general anesthesia without nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue score
A scale from 0-10 was allocated with 0 representing no pain and 10 representing the worst imaginable pain
Measured: immediately after extubation
visual analogue score
A scale from 0-10 was allocated with 0 representing no pain and 10 representing the worst imaginable pain
Measured: 2 hours postoperative
visual analogue score
A scale from 0-10 was allocated with 0 representing no pain and 10 representing the worst imaginable pain
Measured: 4 hours postoperative
visual analogue score
A scale from 0-10 was allocated with 0 representing no pain and 10 representing the worst imaginable pain
Measured: 8 hours postoperative
visual analogue score
A scale from 0-10 was allocated with 0 representing no pain and 10 representing the worst imaginable pain
Measured: 12 hours postoperative
visual analogue score
A scale from 0-10 was allocated with 0 representing no pain and 10 representing the worst imaginable pain
Measured: 16 hours postoperative
visual analogue score
A scale from 0-10 was allocated with 0 representing no pain and 10 representing the worst imaginable pain
Measured: 24 hours postoperative
visual analogue score
A scale from 0-10 was allocated with 0 representing no pain and 10 representing the worst imaginable pain
Measured: 36 hours postoperative
visual analogue score
A scale from 0-10 was allocated with 0 representing no pain and 10 representing the worst imaginable pain
Measured: 48 hours postoperative
Secondary outcomes (3)
Time time to first dose of rescue analgesic
Measured: during 48 hours after operation
Total dose of analgesic needed
Measured: during 48 hours after operation
Complications
number of participants developed complications
Measured: during 48 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start20 May 2023 (estimated)
- Primary completion20 May 2023 (estimated)
- Study completion20 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RAMY AHMED, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791058
- Sponsor's protocol ID
- Ain Shams university 17
- Status last verified
- Mar 2023
- First submitted
- 17 Mar 2023
- Last updated
- 30 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Operative Analgesic Efficacy Of Ultrasound Guided Pericapsular Nerve Group Block Versus Combined Suprascapular And Axillary (Circumflex) Nerve Block For Patients Undergoing Shoulder Arthroscopy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05791058
- Acronym / sponsor ID
- Ain Shams university 17
- Conditions
- Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 May 2023 (estimated)
- Primary completion
- 20 May 2023 (estimated)
- Study completion
- 20 May 2024 (estimated)
- First posted
- 30 Mar 2023 (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.
Recently, the Combined suprascapular nerve block and axillary nerve block (SSNB+ANB) was proposed to provide anesthesia and postoperative analgesia for shoulder surgery as a safe alternative to interscalene block. These two peripheral nerves are responsible for the majority of the sensory innervation of the shoulder.
PENG block has been studied extensively in hip surgeries, but its place in shoulder surgeries is not yet clear. It is a new technology reported for block of articular branches of the shoulder and well pericapsular spread around the glenohumeral joint Therefore, achieving pain relief while avoiding motor block allows us not only to provide an early rehabilitation program in the postoperative period, but also to control the chronic nociceptive activation secondary to pain-induced movement
Detailed description
Preoperative:
Routine preoperative assessment will be done before operation to all patients including history, clinical examination and laboratory investigations (complete blood picture, kidney function tests, liver function tests, pro-thrombin time, and partial thromboplastin time). Chest X-ray, electrocardiogram [ECG] will be done for patients above 40 years old.
All patients will be informed about the study design and objectives as well as tools and techniques. Informed consent will be signed by every patient prior to inclusion in the study.
All patients will be informed about the analgesic regimen and will be instructed on how to express pain intensity with use of the visual analogue scale (VAS) (10cm unmarked line in which 0=no pain, 10cm=the worst imaginable pain)
Anesthetic techniques:
- General Anesthesia Technique: Pre-medications will be given to every patient of the two including groups in the form of midazolam (0.05 mg/kg, IV) together with omeprazole (40 mg, IV) and ondansetron (4 mg, IV) on arrival to the operative room after establishing a peripheral intravenous access. Vital signs will be continuously monitored. After pre-oxygenation for 3 minutes, general anesthesia is induced to all patients with fentanyl (1-2 μg/kg, IV), propofol (1-2mg/Kg, IV), and atracurium (0.5mg/Kg, IV) to facilitate endotracheal intubation. Intermittent positive pressure ventilation of both lungs will be applied (to maintain O2 saturation >98% and end tidal carbon dioxide measurement around 35-38 mmHg). Maintenance of anesthesia will be achieved using intermittent positive pressure ventilation with inhalation of 1-1.5% isoflurane in 50% O2 and atracurium (0.1mg/Kg, IV) every 30 minutes to maintain muscle relaxation.
- Ultrasound guided PENG shoulder block Technique (Group A): The patient's arm is placed in external rotation and abducted at 45 degrees. A linear ultrasound probe will be placed longitudinally between the coracoid and the humeral head. After defining the humeral head, the tendon of the subscapular muscle and the deltoid muscle over it, a 50-mm needle will be inserted using the ''in plane'' technique. When the needle pass through the deltoid muscle and touched the subscapularis tendon, a bone-like hard tissue will be felt and the needle could not be advanced further. The needle tip will be placed between the deltoid muscle and subscapularis tendon, and 20 cc of 0.25% bupivacaine hydrochloride with 4mg dexamesathone will be injected.
- Ultrasound guided combined suprascapular nerve block and axillary nerve block (SSNB+ANB) Technique (Group B):
The ultrasound guided suprascapular nerve block:
The patient will be positioned in a semi-recumbent position with the operating arm on the contralateral shoulder. The probe will be kept over the scapular spine to identify the trapezius and the supraspinatus muscle. Then, it will be moved laterally to identify the concavity of the supraspinatus fossa and the hyper-echoic fascia of the supraspinatus muscle. In the concavity of the fossa, the suprascapular artery and the suprascapular nerve run in close proximity. 10 ml of 0.25% bupivacaine with 2mg dexamethasone will be injected below the supraspinatus fascia.
The ultrasound guided axillary nerve block:
The patients is positioned in a semi-recumbent position with the arm slightly flexed and adducted at the elbow. The posterior surface of the humerus will be visualised in the short axis view. So, the AN and posterior circumflex artery will be visualised longitudinally. 10 ml of 0.25% bupivacaine with 2mg dexamethasone will be injected into space.
The blocks will be considered a failed block if the block is not successful 30 min after the injection of the local anaesthetic.
Group A 20 Patients of this group will receive ultrasound guided pericapsular nerve group shoulder block (PENG Block) at the end of surgery using 20 ml of 0.25% bupivacaine with 4mg dexamethasone with a maximum dose of (3mg/kg).
Group B 20 Patients of this group will receive single shot suprascapular and axillary nerve using a single dose of 10ml of 0.25% bupivacaine with 2mg dexamethasone each at the end of surgery for postoperative pain relief.
Group C 20 patients of this group will receive general anesthesia without nerve block. In the post anesthesia care unit (PACU) for first hour and in ward afterwards , all patients will be assessed for presence and severity of pain at at 1, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours postoperatively or at any time patient suffers from pain with visual analog score and recording its value at any patient visit.
Nalbuphine 0.1 mg/kg is the rescue analgesic that will be given to any patient who will suffer pain with VAS more than 3.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A (ultrasound guided pericapsular nerve group shoulder block) | Active comparator | Procedure: ultrasound guided pericapsular nerve group shoulder block |
| Group B( ultrasound guided suprascapular and axillary nerve block) | Active comparator | Procedure: ultrasound guided suprascapular and axillary nerve block |
| control group | Active comparator | Other: general anesthesia without nerve block |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adults between age of 18 and 60 years old undergoing elective shoulder arthroscopy surgery.
- American society of anesthesiologists classification (ASA) Ⅰ\&Ⅱ
- Males \& Females
Key exclusion criteria (8 listed)
- Age: < 18 or > 60 years old.
- Patients refuse to participate in the study.
- Patients with known hypersensitivity to local anesthetics.
- Coagulation disorder
- Infection at the site of injection
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 |
|---|---|---|
| ultrasound guided pericapsular nerve group shoulder blockThe patient's arm is placed in external rotation and abducted at 45 degrees. A linear ultrasound probe will be placed longitudinally between the coracoid and the humeral head. After defining the humeral head, the tendon of the subscapular muscle and the deltoid muscle over it, a 50-mm needle will be inserted using the ''in plane'' technique. When the needle pass through the deltoid muscle and touched the subscapularis tendon, a bone-like hard tissue will be felt and the needle could not be advanced further. The needle tip will be placed between the deltoid muscle and subscapularis tendon, and 20 cc of 0.25% bupivacaine hydrochloride with 4mg dexamesathone will be injected | Procedure or surgery | Group A (ultrasound guided pericapsular nerve group shoulder block) |
| ultrasound guided suprascapular and axillary nerve blockThe patient will be positioned in a semi-recumbent position with the operating arm on the contralateral shoulder. The probe will be kept over the scapular spine to identify the trapezius and the supraspinatus muscle. Then, it will be moved laterally to identify the concavity of the supraspinatus fossa and the hyper-echoic fascia of the supraspinatus muscle. In the concavity of the fossa, the suprascapular artery and the suprascapular nerve run in close proximity. 10 ml of 0.25% bupivacaine with 2mg dexamethasone will be injected below the supraspinatous fascia then the posterior surface of the humerus will be visualised in the short axis view. So, the AN and posterior circumflex artery will be visualised longitudinally. 10 ml of 0.25% bupivacaine with 2mg dexamethasone will be injected into space | Procedure or surgery | Group B( ultrasound guided suprascapular and axillary nerve block) |
| general anesthesia without nerve blockthis group will receive general anesthesia without nerve block | Other | control group |
Primary outcome
visual analogue score
Time frame: immediately after extubation
A scale from 0-10 was allocated with 0 representing no pain and 10 representing the worst imaginable pain
visual analogue score
Time frame: 2 hours postoperative
A scale from 0-10 was allocated with 0 representing no pain and 10 representing the worst imaginable pain
visual analogue score
Time frame: 4 hours postoperative
A scale from 0-10 was allocated with 0 representing no pain and 10 representing the worst imaginable pain
visual analogue score
Time frame: 8 hours postoperative
A scale from 0-10 was allocated with 0 representing no pain and 10 representing the worst imaginable pain
visual analogue score
Time frame: 12 hours postoperative
A scale from 0-10 was allocated with 0 representing no pain and 10 representing the worst imaginable pain
visual analogue score
Time frame: 16 hours postoperative
A scale from 0-10 was allocated with 0 representing no pain and 10 representing the worst imaginable pain
visual analogue score
Time frame: 24 hours postoperative
A scale from 0-10 was allocated with 0 representing no pain and 10 representing the worst imaginable pain
visual analogue score
Time frame: 36 hours postoperative
A scale from 0-10 was allocated with 0 representing no pain and 10 representing the worst imaginable pain
visual analogue score
Time frame: 48 hours postoperative
A scale from 0-10 was allocated with 0 representing no pain and 10 representing the worst imaginable pain
3 secondary outcomes
Time time to first dose of rescue analgesic
Time frame: during 48 hours after operation
Total dose of analgesic needed
Time frame: during 48 hours after operation
Complications
Time frame: during 48 hours after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound guided pericapsular nerve group shoulder block, ultrasound guided suprascapular and axillary nerve block and general anesthesia without nerve block in people with Post Operative Pain, run by Ain Shams University.
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 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
visual analogue score (time frame: immediately after extubation). The study lists 9 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 30 Mar 2023.