Shoulder PainNCT07626346
Dexmedetomidine as an Adjuvant to Bupivacaine in Ultrasound-guided Pericapsular Nerve Group Block( PENG)
A study testing nerve block in people with Shoulder Pain, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Patients are greatly concerned about pain that occurs shortly after shoulder surgeries. Most patients experience significant pain after shoulder surgery, with almost half reporting severe pain immediately after. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jun 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female patients aged 18-65 years
- Patients Undergoing laparoscopic shoulder surgeries (shoulder arthroplasties and shoulder endoscopic surgeries )
- American Society of Anesthesiologists (ASA) physical status I-II
Who cannot join
- Patient refusal.
- hypersensitivity or contraindication to dexmedetomidine
- History of allergy or intolerance to study medications
- Chronic opioid use (>3 months)
- Pregnancy or breastfeeding
- Severe renal or hepatic impairment
- Patient's with coagulopathy disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Kasr Alainy
Cairo
Ahmed nabih, lecturer, +201002773488, nabihomar100@yahoo.com
About this study
Official title: The Analgesic Efficacy of Dexmedetomidine as an Adjuvant to Bupivacaine in Ultrasound-guided Pericapsular Nerve Group Block( PENG) in Patients Undergoing Laparoscopic Shoulder Surgeries: A Randomized Controlled Trial
Patients are greatly concerned about pain that occurs shortly after shoulder surgeries. Most patients experience significant pain after shoulder surgery, with almost half reporting severe pain immediately after. Since shoulder surgeries are usually done as outpatient or one day procedures, good pain control after surgery is important for quick recovery and rehab for patient's overall recovery. Interscalene nerve blocks provide the best pain relief for shoulder surgery patients. They reduce pain for at least 8 hours and decrease the need for opioids for 8 to 12 hours after surgery. It anesthetizes most of the brachial plexus, except the ulnar nerve (C8-T1). It is useful for surgeries on the distal clavicle, shoulder, and proximal humorous .However, interscalene blocks also raise concerns about temporary and potential long-term problems with breathing, especially paralysis of the diaphragm and phrenic nerve. By targeting nerve roots in the neck rather than peripheral nerves, interscalene blocks also carry a higher risk of nerve damage.The pericapsular nerve group block has been effectively used in hip surgeries as in hip arthroplasty and it is one of the best regional anesthesia regarding many other hip operations. Recently PENG block has also shown to have strong analgesic effect on shoulder surgeries.
Dexmedetomidine (DEX) is a highly selective Alpha-2 adrenergic agonist. It has sedative and analgesic properties that thought to be due to binding to both presynaptic and postsynaptic alpha-2 adrenoreceptors and inhibiting the release of norepinephrine, as a result, it terminates the propagation of pain signals and inhibits the sympathetic activity decreasing heart rate and blood pressure.
The aim of our study is to compare the effect of adding dexmedetomidine to bupivacaine in ultrasound-guided Pericapsular nerve group block (PENG) with bupivacaine alone and determine its effect on duration of analgesia and post-operative opioid consumption.
Read the detailed description
Patients meeting the inclusion criteria will be randomly assigned to receive either:
Group A: PENG block with bupivacaine only (number of patients: 42) Group B: PENG block with bupivacaine and dexmedetomidine (number of patients: 42)
Preoperative assessment:
Preoperative assessment of all patients undergoing elective laparoscopic shoulder surgical procedures under general anaesthesia comprised of history taking, clinical examination, laboratory testing (complete blood count, kidney function tests, and liver function tests), electrocardiogram, and chest X-ray. The study protocol will be explained to the patients, and their consent will be obtained.
The visual analogue score (VAS) will be explained to all patient in details as it will be used as a measurement tool for assessment of postoperative pain
Operating Room preparation \& Equipment:
The ultrasound used will be Siemens ACUSON X300 Ultrasound System, the scanning probe is a linear probe 8-14 MHZ. A 50-mm block needle 22 gauge will be used. (SonoPlex Stim Cannula, Germany).
All blocks will be given by one researcher using 20 ml of drug 0.25% bupivacaine either alone or with dexmedetomedine.
After arrival to the anesthetic room, an 18-gauge intravenous cannula will be placed at the forearm contralateral to the operated arm, standard monitoring will be used (non-invasive arterial blood pressure, ECG, pulse oximetry).
Premedication will be given intravenously in the form of 0.03 mg/kg midazolam, ranitidine 2.0 mg/kg IV and metoclopramide 0.1 mg/kg IV).
Patients will be randomly assigned to either the intervention group will receive PENG block with bupivacaine 0.25% and dexmedetomidine 1 µg/kg (maximum dose of 100 µg) diluted in normal saline (total volume of 20 mL) or control group will receive PENG block with bupivacaine 0.25% (20 mL) diluted in normal saline.
PENG block:
The patient will be asked to lie supine with his or her arm then positioned in a 45-degree abducted external rotation. A linear ultrasound probe was placed lengthwise between the coracoid and humeral head. Once the humeral head, subscapular muscle tendon, and deltoid muscle were identified, a 50-mm needle will be inserted using the "in plane" technique. The needle then will be advanced through the deltoid muscle and towards the subscapularis tendon, until a bony-like hard tissue is felt, preventing further advancement of the needle. The needle is placed now between the deltoid muscle and subscapularis tendon in which injection will be done.
Thirty minutes after performing the block patients will receive general anaesthesia. Anaesthesia will be induced with propofol (2 mg/kg), fentanyl (2 μg/kg) and atracurium (0.5 mg/kg). The GA will be maintained by isoflurane (1.2 %) and Atracurium (0.1 mg/kg/20 min). the surgery will then be started and intraoperative vital signs as heart rate, MAP (mean arterial blood pressure) will be monitored all throughout. If at anytime during the operation hypertension and tachycardia were observed, fentanyl 50 mic will be given as an intraoperative rescue analgesia.
After skin closure, muscle relaxation will be reversed using Neostigmine (0.04mg/kg) and Atropine (0.01mg/kg) after the return of spontaneous breathing. After extubation patients will be transferred to the post-anesthesia care unit (PACU) for 60 min for complete recovery and monitoring.
If at any point hypotension occurred (defined as a decrease in mean arterial pressure > 25% from the baseline value or systolic arterial pressure of 100 mmHg), it will be treated with 5 mg of IV bolus ephedrine, which will be repeated every 3 min until the hypotension resolved. Bradycardia (defined as an HR of 40 beats/min) will be treated with intravenous atropine (0.5 mg).
Postoperative vital signs (heart rate and MAP) and VAS for pain will be recorded at 0, 2, 6, 12, 24 hours and if VAS ≥3 or when the patient asks for analgesia, morphine IV (0.1mg/kg) will be given (rescue analgesia) targeting VAS ≤ 2 while the maximum allowed dose of morphine is 30 mg / 24 hours. The time to first call for analgesia is defined as (the time interval from tracheal extubation to first dose of morphine administration) will be recorded. The patient will receive paracetamol (1gm/8hrs IV) as a regular analgesia as soon as he is discharged from the recovery and admitted to the post-operative ward. The total amount of morphine in the first postoperative 24 hours will be calculated in both groups If the patient requires more than two doses of rescue analgesia in the first hour following surgery, the block will be deemed to have failed.
-Post operative haemodynamic will be assessed (heart rate and MAP at the same time point).
Incidence of adverse effects, such as hypotension, bradycardia, and sedation.
- Conditions
- Shoulder Pain
- Being tested
- nerve block
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nerve blockProcedure or surgery
ultrasound-guided Pericapsular nerve group block
| Study group | Role | What they receive |
|---|---|---|
| PENG block with bupivacaine | Experimental | ultrasound-guided Pericapsular nerve group block with bupivacaine Receives: Procedure: nerve block |
| PENG block with bupivacaine and dexmedetomidine | Experimental | ultrasound-guided Pericapsular nerve group block with bupivacaine and dexmedetomidine Receives: Procedure: nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first rescue analgesia
it is defined as time from extubation until time to first analgesic requirement during the first 24 hours postoperatively.
Measured: the first 24 hours postoperatively
Secondary outcomes (1)
The total opioid consumption
The total opioid consumption in mg
Measured: the first 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 posted4 Jun 2026
- Study start10 Jun 2026
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies 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
- Model description
- Patients will be randomly allocated by a computer-generated table into two of the study groups, the randomization sequence had been concealed in sealed opaque envelopes that will be opened by third doctor who will not participating in the study. The details of the series will be unknown to the investigators and the group assignment will kept in a set of sealed envelopes each bearing only the case number on the outside. This study will be performed by 2 anesthetists; one anesthetist who is experienced in performing the blocks that allocated to perform PENG block with either bupivacaine alone (control group) or bupivacaine with dexmedetomidine (intervention group). According to a computer-generated sequence of random numbers and sealed envelope, and the other anesthetist will be blinded to the technique performed, and will monitor the patients intra and postoperatively.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed nabih youssef, Kasr El Aini Hospital
- Investigators
- Nasr Abdallah, Professor, Study director, anesthesia department , cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07626346
- Sponsor's protocol ID
- MS -493-2023
- Status last verified
- Jun 2026
- First submitted
- 30 May 2026
- Last updated
- 12 Jun 2026
- 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 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analgesic Efficacy of Dexmedetomidine as an Adjuvant to Bupivacaine in Ultrasound-guided Pericapsular Nerve Group Block( PENG) in Patients Undergoing Laparoscopic Shoulder Surgeries: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07626346
- Acronym / sponsor ID
- MS -493-2023
- Conditions
- Shoulder Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 4 Jun 2026 (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.
Patients are greatly concerned about pain that occurs shortly after shoulder surgeries. Most patients experience significant pain after shoulder surgery, with almost half reporting severe pain immediately after. Since shoulder surgeries are usually done as outpatient or one day procedures, good pain control after surgery is important for quick recovery and rehab for patient's overall recovery. Interscalene nerve blocks provide the best pain relief for shoulder surgery patients. They reduce pain for at least 8 hours and decrease the need for opioids for 8 to 12 hours after surgery. It anesthetizes most of the brachial plexus, except the ulnar nerve (C8-T1). It is useful for surgeries on the distal clavicle, shoulder, and proximal humorous .However, interscalene blocks also raise concerns about temporary and potential long-term problems with breathing, especially paralysis of the diaphragm and phrenic nerve. By targeting nerve roots in the neck rather than peripheral nerves, interscalene blocks also carry a higher risk of nerve damage.The pericapsular nerve group block has been effectively used in hip surgeries as in hip arthroplasty and it is one of the best regional anesthesia regarding many other hip operations. Recently PENG block has also shown to have strong analgesic effect on shoulder surgeries.
Dexmedetomidine (DEX) is a highly selective Alpha-2 adrenergic agonist. It has sedative and analgesic properties that thought to be due to binding to both presynaptic and postsynaptic alpha-2 adrenoreceptors and inhibiting the release of norepinephrine, as a result, it terminates the propagation of pain signals and inhibits the sympathetic activity decreasing heart rate and blood pressure.
The aim of our study is to compare the effect of adding dexmedetomidine to bupivacaine in ultrasound-guided Pericapsular nerve group block (PENG) with bupivacaine alone and determine its effect on duration of analgesia and post-operative opioid consumption.
Detailed description
Patients meeting the inclusion criteria will be randomly assigned to receive either:
Group A: PENG block with bupivacaine only (number of patients: 42) Group B: PENG block with bupivacaine and dexmedetomidine (number of patients: 42)
Preoperative assessment:
Preoperative assessment of all patients undergoing elective laparoscopic shoulder surgical procedures under general anaesthesia comprised of history taking, clinical examination, laboratory testing (complete blood count, kidney function tests, and liver function tests), electrocardiogram, and chest X-ray. The study protocol will be explained to the patients, and their consent will be obtained.
The visual analogue score (VAS) will be explained to all patient in details as it will be used as a measurement tool for assessment of postoperative pain
Operating Room preparation \& Equipment:
The ultrasound used will be Siemens ACUSON X300 Ultrasound System, the scanning probe is a linear probe 8-14 MHZ. A 50-mm block needle 22 gauge will be used. (SonoPlex Stim Cannula, Germany).
All blocks will be given by one researcher using 20 ml of drug 0.25% bupivacaine either alone or with dexmedetomedine.
After arrival to the anesthetic room, an 18-gauge intravenous cannula will be placed at the forearm contralateral to the operated arm, standard monitoring will be used (non-invasive arterial blood pressure, ECG, pulse oximetry).
Premedication will be given intravenously in the form of 0.03 mg/kg midazolam, ranitidine 2.0 mg/kg IV and metoclopramide 0.1 mg/kg IV).
Patients will be randomly assigned to either the intervention group will receive PENG block with bupivacaine 0.25% and dexmedetomidine 1 µg/kg (maximum dose of 100 µg) diluted in normal saline (total volume of 20 mL) or control group will receive PENG block with bupivacaine 0.25% (20 mL) diluted in normal saline.
PENG block:
The patient will be asked to lie supine with his or her arm then positioned in a 45-degree abducted external rotation. A linear ultrasound probe was placed lengthwise between the coracoid and humeral head. Once the humeral head, subscapular muscle tendon, and deltoid muscle were identified, a 50-mm needle will be inserted using the "in plane" technique. The needle then will be advanced through the deltoid muscle and towards the subscapularis tendon, until a bony-like hard tissue is felt, preventing further advancement of the needle. The needle is placed now between the deltoid muscle and subscapularis tendon in which injection will be done.
Thirty minutes after performing the block patients will receive general anaesthesia. Anaesthesia will be induced with propofol (2 mg/kg), fentanyl (2 μg/kg) and atracurium (0.5 mg/kg). The GA will be maintained by isoflurane (1.2 %) and Atracurium (0.1 mg/kg/20 min). the surgery will then be started and intraoperative vital signs as heart rate, MAP (mean arterial blood pressure) will be monitored all throughout. If at anytime during the operation hypertension and tachycardia were observed, fentanyl 50 mic will be given as an intraoperative rescue analgesia.
After skin closure, muscle relaxation will be reversed using Neostigmine (0.04mg/kg) and Atropine (0.01mg/kg) after the return of spontaneous breathing. After extubation patients will be transferred to the post-anesthesia care unit (PACU) for 60 min for complete recovery and monitoring.
If at any point hypotension occurred (defined as a decrease in mean arterial pressure > 25% from the baseline value or systolic arterial pressure of 100 mmHg), it will be treated with 5 mg of IV bolus ephedrine, which will be repeated every 3 min until the hypotension resolved. Bradycardia (defined as an HR of 40 beats/min) will be treated with intravenous atropine (0.5 mg).
Postoperative vital signs (heart rate and MAP) and VAS for pain will be recorded at 0, 2, 6, 12, 24 hours and if VAS ≥3 or when the patient asks for analgesia, morphine IV (0.1mg/kg) will be given (rescue analgesia) targeting VAS ≤ 2 while the maximum allowed dose of morphine is 30 mg / 24 hours. The time to first call for analgesia is defined as (the time interval from tracheal extubation to first dose of morphine administration) will be recorded. The patient will receive paracetamol (1gm/8hrs IV) as a regular analgesia as soon as he is discharged from the recovery and admitted to the post-operative ward. The total amount of morphine in the first postoperative 24 hours will be calculated in both groups If the patient requires more than two doses of rescue analgesia in the first hour following surgery, the block will be deemed to have failed.
-Post operative haemodynamic will be assessed (heart rate and MAP at the same time point).
Incidence of adverse effects, such as hypotension, bradycardia, and sedation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomly allocated by a computer-generated table into two of the study groups, the randomization sequence had been concealed in sealed opaque envelopes that will be opened by third doctor who will not participating in the study. The details of the series will be unknown to the investigators and the group assignment will kept in a set of sealed envelopes each bearing only the case number on the outside. This study will be performed by 2 anesthetists; one anesthetist who is experienced in performing the blocks that allocated to perform PENG block with either bupivacaine alone (control group) or bupivacaine with dexmedetomidine (intervention group). According to a computer-generated sequence of random numbers and sealed envelope, and the other anesthetist will be blinded to the technique performed, and will monitor the patients intra and postoperatively.
| Arm | Type | Receives |
|---|---|---|
| PENG block with bupivacaine | Experimental | Procedure: nerve blockultrasound-guided Pericapsular nerve group block with bupivacaine |
| PENG block with bupivacaine and dexmedetomidine | Experimental | Procedure: nerve blockultrasound-guided Pericapsular nerve group block with bupivacaine and dexmedetomidine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female patients aged 18-65 years
- Patients Undergoing laparoscopic shoulder surgeries (shoulder arthroplasties and shoulder endoscopic surgeries )
- American Society of Anesthesiologists (ASA) physical status I-II
Key exclusion criteria (7 listed)
- Patient refusal.
- hypersensitivity or contraindication to dexmedetomidine
- History of allergy or intolerance to study medications
- Chronic opioid use (>3 months)
- Pregnancy or breastfeeding
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 |
|---|---|---|
| nerve blockultrasound-guided Pericapsular nerve group block | Procedure or surgery | PENG block with bupivacaine, PENG block with bupivacaine and dexmedetomidine |
Primary outcome
Time to first rescue analgesia
Time frame: the first 24 hours postoperatively
it is defined as time from extubation until time to first analgesic requirement during the first 24 hours postoperatively.
1 secondary outcome
The total opioid consumption
Time frame: the first 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
Related trials for Shoulder Pain
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
Hybrid mHealth and Telerehabilitation vs Conventional Physiotherapy for Subacromial Pain Syndrome
Subacromial Pain Syndrome
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Active, not recruiting
Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
Frozen Shoulder
Not yet recruiting
Laser Therapy Versus Transcutaneous Electical Nerve Stimulation at Hemiplegic Shoulder Pain
Hemiplegic Shoulder Pain
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.
Nasr Abdallah, Professor study director
anesthesia department , cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nerve block in people with Shoulder Pain, run by Kasr El Aini Hospital 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 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: looking for participants now, as of the sponsor's last update on 12 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed nabih, lecturer (+201002773488, nabihomar100@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first rescue analgesia (time frame: the first 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 12 Jun 2026.