Rotator CuffNCT05668533
Intrscalene Block Versus Pericapsular Nerve Group Block for Arthroscopic Shoulder Surgery
A study testing Interscalene versus PENG Block in people with Rotator Cuff and Bankert Repair, run by Alexandria University at 1 site in Egypt.
Trial summary
Early postoperative pain after arthroscopic shoulder surgery is a major problem for patients and orthopedic surgeons. Adequate pain control is vital for all aspects of patient recovery; including mental state, nutrition, cost of care period, rehabilitation, patient satisfaction, and overall post-surgery outcomes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rotator Cuff, Bankert Repair
- What is being tested?
- Interscalene versus PENG Block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2022to Mar 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status class I - II
- patient who will be scheduled for an elective unilateral arthroscopic shoulder surgery
Who cannot join
- Patients with respiratory disease, renal or hepatic insufficiency,
- infection of the skin in the puncture area,
- coagulopathy,
- allergy against any of the drugs to be used (bupivacaine),
- neuromuscular disease,
- obesity (body mass index, BMI >30),
- previous analgesic medication, chronic pain, and previously known neurological pathologies or central nervous system disorders
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Rehab A. Abd El-Aziz
Alexandria, 000000
rehab a. abd ei-aziz, ass. prof, 01001073703 ext. 020, trcium2002@yahoo.com
About this study
Official title: Comparing Postoperative Analgesic Efficiency of Intrscalene Block Versus Pericapsular Nerve Group Block for Arthroscopic Shoulder Surgery: A Randomized Controlled Clinical Trial
Early postoperative pain after arthroscopic shoulder surgery is a major problem for patients and orthopedic surgeons. Adequate pain control is vital for all aspects of patient recovery; including mental state, nutrition, cost of care period, rehabilitation, patient satisfaction, and overall post-surgery outcomes. (1) Single analgesic regimens are not always effective in controlling moderate to severe postoperative pain. Therefore, multimodal pain management is preferred and is currently recommended for early postoperative pain control.(2) Regional techniques form an integral part of multimodal analgesia of most of the enhanced recovery protocols and aid in minimizing the requirements of opioids to control acute postoperative pain which results in better, faster recovery and better satisfaction. Also, it is well known that sufficient management of acute pain is essential to prevent its transition to chronic pain.(3) The use of ultrasound guidance and its incorporation into the practice of regional anesthesia has dramatically improved the safety and success of perioperative care.(4) Ultrasound guided regional anesthesia is preferred in shoulder surgery as an effective way to provide anesthesia and postoperative analgesia. To ensure adequate postoperative pain control, nerve supply to the synovium, capsule, joint surfaces, ligaments, periosteum and shoulder muscles must be blocked.
Interscalene brachial plexus (ISB) block is considered the analgesic technique of choice for shoulder surgery. However, the hemi-diaphragmatic paresis that may occur after the block has led to the search for an alternative to the ISB block. (5) Pericapsular nerve group block (PENG) is a new block that provides a pericapsular distribution with local anesthetic infiltration around the glenohumeral joint and provides analgesia by reaching the sensory nerve branches of the glenohumeral joint. The block of this area did not cause motor block or pulmonary complications, nor result in muscle laxity, blocking only the shoulder and the upper third of the humerus. It was demonstrated that the PENG block may be safely applied for both partial anesthesia and analgesia.(6)
- Conditions
- Rotator Cuff, Bankert Repair
- Being tested
- Interscalene versus PENG Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interscalene versus PENG BlockDiagnostic test
- Interscalene group: Patients received ipsilateral ultrasound-guided interscalene nerve after induction of general anesthesia using bupivacaine 0.25% (0.5 mL/kg).
- PENG Block: Patients received ultrasound-guided PENG block after induction of general anesthesia using bupivacaine 0.25% (0.5 mL/kg).
| Study group | Role | What they receive |
|---|---|---|
| 1. Interscalene group | Active comparator | Patients received ipsilateral ultrasound-guided interscalene nerve after induction of general anesthesia using bupivacaine 0.25% (0.5 mL/kg). Receives: Diagnostic Test: Interscalene versus PENG Block |
| 2. PENG Block | Active comparator | Patients received ultrasound-guided PENG block after induction of general anesthesia using bupivacaine 0.25% (0.5 mL/kg). Receives: Diagnostic Test: Interscalene versus PENG Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale
visual analogue scale to assess the analgesic efficacy of ultrasound-guided intrscalene block versus PENG Block
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2022
- Study startDec 2022 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator CuffStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Model description
- 1. Interscalene group: Patients received ipsilateral ultrasound-guided interscalene nerve after induction of general anesthesia using bupivacaine 0.25% (0.5 mL/kg). 2. PENG Block: Patients received ultrasound-guided PENG block after induction of general anesthesia using bupivacaine 0.25% (0.5 mL/kg).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rehab zayed, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05668533
- Sponsor's protocol ID
- 0305847
- Status last verified
- Dec 2022
- First submitted
- 10 Dec 2022
- Last updated
- 30 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Postoperative Analgesic Efficiency of Intrscalene Block Versus Pericapsular Nerve Group Block for Arthroscopic Shoulder Surgery: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05668533
- Acronym / sponsor ID
- 0305847
- Conditions
- Rotator Cuff, Bankert Repair
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 30 Dec 2022 (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.
Early postoperative pain after arthroscopic shoulder surgery is a major problem for patients and orthopedic surgeons. Adequate pain control is vital for all aspects of patient recovery; including mental state, nutrition, cost of care period, rehabilitation, patient satisfaction, and overall post-surgery outcomes. (1) Single analgesic regimens are not always effective in controlling moderate to severe postoperative pain. Therefore, multimodal pain management is preferred and is currently recommended for early postoperative pain control.(2) Regional techniques form an integral part of multimodal analgesia of most of the enhanced recovery protocols and aid in minimizing the requirements of opioids to control acute postoperative pain which results in better, faster recovery and better satisfaction. Also, it is well known that sufficient management of acute pain is essential to prevent its transition to chronic pain.(3) The use of ultrasound guidance and its incorporation into the practice of regional anesthesia has dramatically improved the safety and success of perioperative care.(4) Ultrasound guided regional anesthesia is preferred in shoulder surgery as an effective way to provide anesthesia and postoperative analgesia. To ensure adequate postoperative pain control, nerve supply to the synovium, capsule, joint surfaces, ligaments, periosteum and shoulder muscles must be blocked.
Interscalene brachial plexus (ISB) block is considered the analgesic technique of choice for shoulder surgery. However, the hemi-diaphragmatic paresis that may occur after the block has led to the search for an alternative to the ISB block. (5) Pericapsular nerve group block (PENG) is a new block that provides a pericapsular distribution with local anesthetic infiltration around the glenohumeral joint and provides analgesia by reaching the sensory nerve branches of the glenohumeral joint. The block of this area did not cause motor block or pulmonary complications, nor result in muscle laxity, blocking only the shoulder and the upper third of the humerus. It was demonstrated that the PENG block may be safely applied for both partial anesthesia and analgesia.(6)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 1. Interscalene group: Patients received ipsilateral ultrasound-guided interscalene nerve after induction of general anesthesia using bupivacaine 0.25% (0.5 mL/kg). 2. PENG Block: Patients received ultrasound-guided PENG block after induction of general anesthesia using bupivacaine 0.25% (0.5 mL/kg).
| Arm | Type | Receives |
|---|---|---|
| 1. Interscalene group | Active comparator | Diagnostic Test: Interscalene versus PENG BlockPatients received ipsilateral ultrasound-guided interscalene nerve after induction of general anesthesia using bupivacaine 0.25% (0.5 mL/kg). |
| 2. PENG Block | Active comparator | Diagnostic Test: Interscalene versus PENG BlockPatients received ultrasound-guided PENG block after induction of general anesthesia using bupivacaine 0.25% (0.5 mL/kg). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA physical status class I - II
- patient who will be scheduled for an elective unilateral arthroscopic shoulder surgery
Key exclusion criteria (7 listed)
- Patients with respiratory disease, renal or hepatic insufficiency,
- infection of the skin in the puncture area,
- coagulopathy,
- allergy against any of the drugs to be used (bupivacaine),
- neuromuscular disease,
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 versus PENG Block1. Interscalene group: Patients received ipsilateral ultrasound-guided interscalene nerve after induction of general anesthesia using bupivacaine 0.25% (0.5 mL/kg). 2. PENG Block: Patients received ultrasound-guided PENG block after induction of general anesthesia using bupivacaine 0.25% (0.5 mL/kg). | Diagnostic test | 1. Interscalene group, 2. PENG Block |
Primary outcome
visual analogue scale
Time frame: 24 hours postoperative
visual analogue scale to assess the analgesic efficacy of ultrasound-guided intrscalene block versus PENG Block
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2022.
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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.
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 versus PENG Block in people with Rotator Cuff and Bankert Repair, run by Alexandria 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 2 inclusion and 7 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 Dec 2022. 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 Rehab A. Abd El- Aziz, ass. prof (01001073703 ext. 020, trcium2002@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analogue scale (time frame: 24 hours postoperative). 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 Dec 2022.