ClinicalTrials.gg
RecruitingNCT07626346Updated Jun 12, 2026

Dexmedetomidine as an Adjuvant to Bupivacaine in Ultrasound-guided Pericapsular Nerve Group Block( PENG)

An interventional study of nerve block in Shoulder Pain, sponsored by Kasr El Aini Hospital. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-12.

Sponsored by Kasr El Aini Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2026; still recruiting 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 40 studies in Shoulder Pain with a site in Egypt — 13 open to participants now, 14 under way, none of them phase 3. Shoulder Pain · Egypt.

Planned enrollment
6th of 35
84 · median 60
Started
2026
with 5 others
No phase
29 of 40
11 open now
Primary completion
2026-11
later than 12 of 13 live
Registered
38th of 40
by date

Among the 40 studies in Shoulder Pain with a site in Egypt, this one is the 6th largest by planned enrollment of the 35 interventional ones, is one of 6 that started in 2026, is one of 29 with no phase, reaches primary completion later than 12 of the 13 other live ones, and was the 38th registered.

By phase

40 studies; the count open now beside each. This study's row is marked.

No phasethis study29 · 11 open
Observational5 · 2 open
Phase 1/22 · 0 open
Phase 11 · 0 open
Phase 2/31 · 0 open
Phase 31 · 0 open
Phase 41 · 0 open

By the year they started

First in 2013; this study’s year is marked. 6 started in 2026.

Size and results

Median enrollment 60 across the 35 interventional studies, 100 across the 5 observational. Of the 22 that completed or were terminated, 0 (0%) have results posted.

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02

Study 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. 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.

03

Conditions studied

  • Shoulder Pain

Browse trials for

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or female patients aged 18-65 years
  2. Patients Undergoing laparoscopic shoulder surgeries (shoulder arthroplasties and shoulder endoscopic surgeries )
  3. (ASA) physical status I-II

Exclusion criteria

Exclusion Criteria:

  1. Patient refusal.
  2. or to dexmedetomidine
  3. History of allergy or intolerance to study medications
  4. Chronic opioid use (>3 months)
  5. Pregnancy or breastfeeding
  6. Severe renal or hepatic impairment
  7. Patient's with coagulopathy disorders
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
84 participants (estimated)

Study arms

  • Experimental
    PENG block with bupivacaine

    ultrasound-guided Pericapsular nerve group block with bupivacaine

    Procedure: nerve block

  • Experimental
    PENG block with bupivacaine and dexmedetomidine

    ultrasound-guided Pericapsular nerve group block with bupivacaine and dexmedetomidine

    Procedure: nerve block

Interventions

  • Procedurenerve block

    ultrasound-guided Pericapsular nerve group block

06

What researchers measure

Primary outcomes

  1. Time to first rescue analgesia

    it is defined as time from extubation until time to first analgesic requirement during the first 24 hours postoperatively.

    Time frame: the first 24 hours postoperatively

Secondary outcomes

  1. The total opioid consumption

    The total opioid consumption in mg

    Time frame: the first 24 hours postoperatively

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2026 (actual). Primary completion is estimated for Nov 2026, 5 months after the start.

Of 349 non-industry interventional studies with no phase under Shoulder Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 27. This study's planned 5 months is below that.

Counting every sponsor, half of 354 studies reached it within 11 months; a quarter within 4 and three quarters within 27.

How these figures are worked out, and which studies are left out of them.

Registered
May 30, 2026
First posted
Jun 4, 2026
StartActual
Jun 10, 2026
Primary completionEst.
Nov 2026
CompletionEst.
Nov 2026
Last update
Jun 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07626346
Responsible party
Ahmed nabih youssef (lecturer of anethesia, Kasr El Aini Hospital) — Principal investigator
First posted
Jun 4, 2026
Start date
Jun 10, 2026
Primary completion
Nov 2026 (estimated)
Completion
Nov 2026 (estimated)
Last update
Jun 12, 2026

Study contacts

Ahmed nabih, lecturer
Contact
nabihomar100@yahoo.com
+201002773488
Mohammed Belita, lecturer
Contact
mbeleta75@gmail.com
+201001007485
Nasr Abdallah, Professor
study director · anesthesia department , cairo university

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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