Pericapsular Nerve BlockNCT06235879
Comparison Between Pericapsular Nerve Group (PENG) Block and Interscalene Brachial Plexus Block for Postoperative Analgesia Following Shoulder Arthroscopy
A study testing Pericapsular nerve group (PENG) block in people with Pericapsular Nerve Block and Interscalene Brachial Plexus Block, run by Ain Shams University at 1 site in Egypt.
Trial summary
The study aimed to compare ultrasound guided pericapsular nerve group (PENG) block versus interscalene brachial plexus block for postoperative analgesia following shoulder arthroscopy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pericapsular Nerve Block, Interscalene Brachial Plexus Block, Shoulder Arthroscopy
- What is being tested?
- Pericapsular nerve group (PENG) block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to 1 Dec 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
- Age from 18 to 60 years old. - Both genders. - BMI ≤35 kg/m2. - American Society of Anesthesiologists Physical Status (ASA-PS) Class I and II. - Patient who will be scheduled for an elective unilateral arthroscopic shoulder surgery.
Who cannot join
- Refusal of procedure or participation in the study
- Patient under age of 18 years old or above 60 years' old
- Physical status: ASA-PS III or above.
- Pregnancy or lactation.
- Infection at site of injection.
- Psychiatric illness.
Show all 12Show fewer
- CNS Diseases like (epilepsy, stroke …etc.) or neurological disease affecting patient's upper limb.
- Evidence of coagulopathy or anticoagulation.
- Patients with respiratory disease, renal or hepatic insufficiency.
- infection of the skin in the puncture area.
- Allergy against any of the drugs to be used.
- Obesity (BMI >35 kg/m2).
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo, 11591
Mohammed S Mohammed, Master, 00201060103441, mohamedsabry0101808@med.asu.edu.eg
Hoda O Mahmoud, Professor
About this study
Official title: Comparison Between Ultrasound Guided Pericapsular Nerve Group (PENG) Block and Interscalene Brachial Plexus Block for Postoperative Analgesia Following Shoulder Arthroscopy: Prospective, Randomized Controlled Trial
The study aimed to compare ultrasound guided pericapsular nerve group (PENG) block versus interscalene brachial plexus block for postoperative analgesia following shoulder arthroscopy.
Read the detailed description
Shoulder arthroscopy can effectively treat a number of injuries and diseases of the shoulder on an ambulatory basis. Although shoulder arthroscopy is considered minimally invasive, it is related to severe postoperative pain. The use of arthroscopy is popular because it decreases pain, shortens hospital stay, and improves patient satisfaction. However, immediate postoperative pain remains to be a problem in more than 40% of patients.
Regional anesthesia, especially peripheral nerve blocks have various advantages like decreased need for postoperative analgesics, decreased incidence of nausea and vomiting, shortened recovery time and hospital stay, Early ambulation and discharge.
Interscalene brachial plexus (ISB) block is considered the gold standard technique for pain management in shoulder surgery as it provides the most reliable analgesia. However, it has the potential for many complications. The most common of these complications is phrenic nerve palsy, which is reversible but may result in significant respiratory distress especially in patients with compromised respiratory function. Other less common yet serious complications include Horner's syndrome, recurrent laryngeal nerve block that may result in hoarseness of voice, vascular puncture, brachial plexus neuropathy, and unintended injection of local anesthetic into the subarachnoid space, epidural space, or vertebral artery.
Pericapsular nerve group (PENG) block 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.
- Being tested
- Control Group (Interscalene brachial plexus block), Pericapsular nerve group (PENG) block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control Group (Interscalene brachial plexus block)Other
Patients will receive ultrasound guided interscalene brachial plexus block after induction of general anesthesia.
Scanning with SonoSite M-Turbo C ® Ultrasound device with HFL - 38 X Linear probe (Japan) with high frequency (6 -13 MHz) will be started just below the level of the cricoid cartilage medial to the sternocleidomastoid muscle.
the transducer will be moved slightly laterally across the neck to identify the scalene muscles and the brachial plexus that is present between the anterior and middle scalene muscles at the level of the sixth cervical vertebra deep to the sternocleidomastoid muscle.
The needle will be then inserted in-plane toward the brachial plexus, in a lateral-to-medial direction.
After negative aspiration and assurance that high resistance to injection is absent, 0.25% bupivacaine hydrochloride will be injected in a 5-ml increment below the lower root, between the 3 roots, and above the upper root.(Total amount is 15 ml of 0.25% bupivacaine hydrochloride).
Pericapsular nerve group (PENG) blockProcedure or surgery
Patients will receive ultrasound guided Pericapsular nerve group (PENG) block after induction of general anesthesia.
Using SonoSite M-Turbo C ® Ultrasound device with HFL - 38 X Linear probe (Japan) with high frequency (6 -13 MHz) ,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 can't be advanced further.
The needle tip will be placed between the deltoid muscle and subscapularis tendon, after a careful aspiration, 15 ml of 0.25% bupivacaine hydrochloride will be injected.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Control Group | Other | Patients will receive ultrasound guided Interscalene brachial plexus (ISB) block after induction of general anesthesia. Receives: Other: Control Group (Interscalene brachial plexus block) |
| Group B (Pericapsular nerve group (PENG) block) | Experimental | Patients will receive ultrasound guided Pericapsular nerve group (PENG) block after induction of general anesthesia Receives: Procedure: Pericapsular nerve group (PENG) block |
What is being measured
The primary outcome is the main question the study is designed to answer.
First time for requiring analgesia
First time for requiring analgesia. It will be defined as the time from recovery until VAS score greater than 3.
Measured: 24 hours postoperatively
Secondary outcomes (3)
Total amount of pethidine consumption in the first 24 hours
If the patient complained of pain, intravenous pethidine sulfate will be (50mg/dose) to be repeated on demand (VAS is > 3) provided that the total 24-hour dosage not to exceed 50 mg every 6 hours.
Measured: 24 hours postoperatively
The degree of pain
The degree of pain will be measured using visual analogue scale (VAS)ranging from 0 to 10, where 0 no pain and 10 maximum pain. It will be evaluated on arrival to PACU (T0) then at 2, 4, 6, 12, and 24 h postoperatively.
Measured: 24 hours postoperatively
Complications
Any complications during and after the performance of the block - for example, pneumothorax, Horner's syndrome, hoarseness of voice, difficulty in breathing, weakness, and paresthesia in the arm will be 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 posted1 Feb 2024
- Study start1 Feb 2024
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pericapsular Nerve BlockStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Sabry B Mohamed, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06235879
- Sponsor's protocol ID
- FMASU MD298/2023
- Status last verified
- Feb 2024
- First submitted
- 20 Jan 2024
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- 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.
Publications
Hassan RMM, Alansary AM, Mahmoud HO, Mohammed MSB, Nakhla G. Comparison between ultrasound guided pericapsular nerve group (PENG) block and interscalene brachial plexus block for postoperative analgesia following shoulder arthroscopy: a randomized controlled trial. BMC Anesthesiol. 2026 Jun 29;26(1):382. doi: 10.1186/s12871-026-04038-w.
PubMed 42366342
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Ultrasound Guided Pericapsular Nerve Group (PENG) Block and Interscalene Brachial Plexus Block for Postoperative Analgesia Following Shoulder Arthroscopy: Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06235879
- Acronym / sponsor ID
- FMASU MD298/2023
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 1 Feb 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.
The study aimed to compare ultrasound guided pericapsular nerve group (PENG) block versus interscalene brachial plexus block for postoperative analgesia following shoulder arthroscopy.
Detailed description
Shoulder arthroscopy can effectively treat a number of injuries and diseases of the shoulder on an ambulatory basis. Although shoulder arthroscopy is considered minimally invasive, it is related to severe postoperative pain. The use of arthroscopy is popular because it decreases pain, shortens hospital stay, and improves patient satisfaction. However, immediate postoperative pain remains to be a problem in more than 40% of patients.
Regional anesthesia, especially peripheral nerve blocks have various advantages like decreased need for postoperative analgesics, decreased incidence of nausea and vomiting, shortened recovery time and hospital stay, Early ambulation and discharge.
Interscalene brachial plexus (ISB) block is considered the gold standard technique for pain management in shoulder surgery as it provides the most reliable analgesia. However, it has the potential for many complications. The most common of these complications is phrenic nerve palsy, which is reversible but may result in significant respiratory distress especially in patients with compromised respiratory function. Other less common yet serious complications include Horner's syndrome, recurrent laryngeal nerve block that may result in hoarseness of voice, vascular puncture, brachial plexus neuropathy, and unintended injection of local anesthetic into the subarachnoid space, epidural space, or vertebral artery.
Pericapsular nerve group (PENG) block 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Control Group | Other | Other: Control Group (Interscalene brachial plexus block)Patients will receive ultrasound guided Interscalene brachial plexus (ISB) block after induction of general anesthesia. |
| Group B (Pericapsular nerve group (PENG) block) | Experimental | Procedure: Pericapsular nerve group (PENG) blockPatients will receive ultrasound guided Pericapsular nerve group (PENG) block after induction of general anesthesia |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age from 18 to 60 years old. - Both genders. - BMI ≤35 kg/m2. - American Society of Anesthesiologists Physical Status (ASA-PS) Class I and II. - Patient who will be scheduled for an elective unilateral arthroscopic shoulder surgery.
Key exclusion criteria (12 listed)
- Refusal of procedure or participation in the study
- Patient under age of 18 years old or above 60 years' old
- Physical status: ASA-PS III or above.
- Pregnancy or lactation.
- Infection at 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 |
|---|---|---|
| Control Group (Interscalene brachial plexus block)Patients will receive ultrasound guided interscalene brachial plexus block after induction of general anesthesia. Scanning with SonoSite M-Turbo C ® Ultrasound device with HFL - 38 X Linear probe (Japan) with high frequency (6 -13 MHz) will be started just below the level of the cricoid cartilage medial to the sternocleidomastoid muscle. the transducer will be moved slightly laterally across the neck to identify the scalene muscles and the brachial plexus that is present between the anterior and middle scalene muscles at the level of the sixth cervical vertebra deep to the sternocleidomastoid muscle. The needle will be then inserted in-plane toward the brachial plexus, in a lateral-to-medial direction. After negative aspiration and assurance that high resistance to injection is absent, 0.25% bupivacaine hydrochloride will be injected in a 5-ml increment below the lower root, between the 3 roots, and above the upper root.(Total amount is 15 ml of 0.25% bupivacaine hydrochloride). | Other | Group A (Control Group |
| Pericapsular nerve group (PENG) blockPatients will receive ultrasound guided Pericapsular nerve group (PENG) block after induction of general anesthesia. Using SonoSite M-Turbo C ® Ultrasound device with HFL - 38 X Linear probe (Japan) with high frequency (6 -13 MHz) ,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 can't be advanced further. The needle tip will be placed between the deltoid muscle and subscapularis tendon, after a careful aspiration, 15 ml of 0.25% bupivacaine hydrochloride will be injected. | Procedure or surgery | Group B (Pericapsular nerve group (PENG) block) |
Primary outcome
First time for requiring analgesia
Time frame: 24 hours postoperatively
First time for requiring analgesia. It will be defined as the time from recovery until VAS score greater than 3.
3 secondary outcomes
Total amount of pethidine consumption in the first 24 hours
Time frame: 24 hours postoperatively
The degree of pain
Time frame: 24 hours postoperatively
Complications
Time frame: 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Derived from this study: PubMed 42366342Hassan RMM, Alansary AM, Mahmoud HO, Mohammed MSB, Nakhla G. Comparison between ultrasound guided pericapsular nerve group (PENG) block and interscalene brachial plexus block for postoperative analgesia following shoulder arthroscopy: a randomized controlled trial. BMC Anesthesiol. 2026 Jun 29;26(1):382. doi: 10.1186/s12871-026-04038-w.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pericapsular nerve group (PENG) block in people with Pericapsular Nerve Block and Interscalene Brachial Plexus Block, run by Ain Shams 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 1 inclusion and 12 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 2 Feb 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?
Contact Mohammed S Mohammed, Master (00201060103441, mohamedsabry0101808@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First time for requiring analgesia (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?
On the ClinicalTrials.gov record for NCT06235879, which also lists 1 linked publication.
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 2 Feb 2024.