An interventional study of Bupivacaine and Dexmedetomidine in Postoperative Pain, Diaphragmatic Paralysis and Shoulder Arthroscopic Surgery, sponsored by Beni-Suef University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Beni-Suef University · Not applicable, Interventional, and Treatment
This study evaluates whether ultrasound-guided pericapsular nerve block (PENB) combined with superficial cervical plexus block (SCPB), using bupivacaine enhanced with dexmedetomidine, provides postoperative pain control that is non-inferior to dexmedetomidine-enhanced interscalene block (ISB) in patients undergoing elective arthroscopic shoulder surgery.
Interscalene block is the standard regional anesthesia technique for shoulder procedures, but it frequently causes hemidiaphragmatic paralysis (temporary partial or complete weakening of the diaphragm). While the combination of PENB and SCPB avoids motor blockade to the diaphragm, plain local anesthetics may not provide long-lasting analgesia beyond 18 to 24 hours. This randomized trial investigates whether adding perineural dexmedetomidine (a medication that extends regional block duration) to both block techniques delivers equivalent 24-hour pain relief and recovery while significantly reducing the occurrence of diaphragmatic paralysis.
BACKGROUND AND RATIONALE:
Arthroscopic shoulder surgery (ASS) causes severe postoperative pain during the first 24 to 72 hours. While interscalene brachial plexus block (ISB) is the analgesic gold standard, it carries a high incidence of hemidiaphragmatic paralysis (HDP) due to phrenic nerve involvement. Multi-injection motor-sparing techniques, such as pericapsular nerve block (PENB) combined with superficial cervical plexus block (SCPB), significantly reduce HDP risk. However, plain bupivacaine in PENB+SCPB lacks extended duration. Perineural dexmedetomidine (0.5 μg/kg) is added to both study arms at an equal total dose to close the durability gap while preserving blinding and clinical equipoise.
STUDY PROCEDURES:
All participants receive a standardized general anesthesia protocol (induction with propofol 2 mg/kg, fentanyl 2 μg/kg, atracurium 0.5 mg/kg; maintenance with isoflurane and oxygen/air). Following induction, ultrasound-guided blocks are performed under strict aseptic conditions:
POSTOPERATIVE MANAGEMENT \& ASSESSMENTS:
Standard post-op analgesia consists of scheduled IV paracetamol (1 g q8h) and IV ketorolac (30 mg q12h), with IV rescue fentanyl (25-50 μg) for Numerical Rating Scale (NRS) pain scores >3. Pain scores, vital signs, diaphragmatic ultrasound excursions (PACU, 24 h, 48 h), QoR-15 quality of recovery scores (24 h, 48 h, 72 h), and block-related adverse events are prospectively tracked through 72 hours postoperatively.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 80 is close to the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Beni-Suef University is the lead sponsor of 349 studies on the registry; 125 are open to participants now.
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Exclusion Criteria:
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.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive an ultrasound-guided interscalene brachial plexus block (ISB) following general anesthesia induction. Under aseptic technique and linear ultrasound probe guidance, 15 mL of 0.25% bupivacaine mixed with dexmedetomidine 0.5 µg/kg (maximum 50 µg) is deposited around the brachial plexus trunks between the anterior and middle scalene muscles.
Drug: Bupivacaine · Drug: Dexmedetomidine · Procedure: Interscalene Brachial Plexus Block
Patients receive a combined ultrasound-guided pericapsular nerve block (PENB) and superficial cervical plexus block (SCPB) following general anesthesia induction. Total local anesthetic volume (15 mL of 0.25% bupivacaine) and total dexmedetomidine dose (0.5 µg/kg, max 50 µg) are divided as follows: (1) PENB: 10 mL of 0.25% bupivacaine with \~0.33 µg/kg dexmedetomidine (two-thirds total dose) injected in the interfascial plane between deltoid and subscapularis muscles; (2) SCPB: 5 mL of 0.25% bupivacaine with \~0.17 µg/kg dexmedetomidine (one-third total dose) injected between investing and prevertebral fasciae at the posterior border of the sternocleidomastoid muscle.
Drug: Bupivacaine · Drug: Dexmedetomidine · Procedure: Pericapsular Nerve Block plus Superficial Cervical Plexus Block
0.25% solution administered as a total volume of 15 mL per patient for regional nerve blockade prior to surgery.
Also known as: Marcaine, Bupivacaine Hydrochloride
Perineural adjuvant added to bupivacaine at a total weight-adjusted dose of 0.5 µg/kg (maximum 50 µg) per patient to prolong block duration.
Also known as: Precedex
Ultrasound-guided single-injection interscalene brachial plexus nerve block.
Ultrasound-guided dual-injection motor-sparing regional nerve block combination.
Cumulative Fentanyl Consumption at 24 Hours
Cumulative dose of intravenous rescue fentanyl (in micrograms) administered over the first 24 postoperative hours for pain scores (Numerical Rating Scale \> 3). Non-inferiority margin is pre-specified at 45 µg. A lower value indicates a better outcome (less pain/reduced opioid requirement).
Time frame: 24 hours postoperatively
Incidence of Hemidiaphragmatic Paralysis at 2 Hours
Percentage of participants with diaphragmatic paralysis assessed via ultrasound M-mode excursion during deep inspiration (sniff/sigh maneuvers). Complete paralysis is defined as \>75% reduction in excursion, paradoxical movement, or immobility; partial paralysis is 25-75% reduction. Reported as the percentage of patients with partial or complete paralysis. A lower percentage indicates a better outcome (greater diaphragm preservation).
Time frame: 2 hours postoperatively
Postoperative Pain Intensity Scores From 0 to 72 Hours
Pain intensity assessed using the 11-point Numerical Rating Scale (NRS), where 0 represents "no pain" and 10 represents "worst imaginable pain". Assessed at rest and movement across scheduled post-op time points. Lower scores indicate a better outcome (less pain).
Time frame: Post-anesthesia care unit (PACU) arrival, and at 2, 4, 6, 12, 18, 24, 48, and 72 hours postoperatively
Time to First Request for Rescue Analgesia
Time elapsed (in minutes) from completion of block placement until the patient's first request for IV rescue fentanyl (NRS \> 3). A higher duration (longer time) indicates a better outcome (prolonged analgesic effect).
Time frame: Up to 72 hours postoperatively
Total 72-Hour Cumulative Opioid Consumption
Total cumulative postoperative opioid consumption converted to oral Morphine Milligram Equivalents (MME) over 72 hours. A lower total value indicates a better outcome (reduced overall opioid exposure).
Time frame: 72 hours postoperatively
Quality of Recovery Score (QoR-15) at 24, 48, and 72 Hours
Validated 15-item patient-reported questionnaire evaluating health status after surgery. Total score ranges from 0 to 150, where higher scores indicate a better outcome (superior overall quality of recovery).
Time frame: Preoperatively (baseline), and at 24, 48, and 72 hours postoperatively
Patient Satisfaction Score at 24 Hours
Patient satisfaction measured on a 5-point Likert scale (1 = Very Dissatisfied, 5 = Very Satisfied). Higher scores indicate a better outcome (greater patient satisfaction).
Time frame: 24 hours postoperatively
Incidence of Block-Related and Anesthesia Complications
Number of participants experiencing adverse events including Horner syndrome, hoarseness, vascular puncture, nausea/vomiting, bradycardia (\<50 bpm), hypotension, or respiratory depression. A lower incidence/count indicates a better outcome (greater clinical safety).
Time frame: Up to 72 hours postoperatively
Length of PACU Stay and Time to Discharge Readiness
Duration of PACU stay (in minutes) and time to meeting standardized discharge criteria (modified Aldrete score ≥ 9). Lower time durations indicate a better outcome (faster recovery and earlier discharge readiness).
Time frame: Up to 24 hours postoperatively
Plan to share: Yes — De-identified individual participant data (including demography, diaphragmatic ultrasound excursion measurements, NRS pain scores, hourly rescue opioid consumption, and QoR-15 response scores) will be made available to qualified clinical research investigators following publication of the primary trial results. Data will be shared exclusively for scientific research purposes to support secondary analyses or meta-analyses.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data will become available starting 6 months following publication of the primary manuscript in a peer-reviewed journal and will remain accessible for up to 36 months.
Access criteria: Access to de-identified IPD will be granted to qualified academic researchers upon submission of a formal research proposal and signed Data Use Agreement (DUA). Requests should be submitted directly to the principal investigator via email (Kmnmk87@med.bsu.edu.eg).
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Apr 2027, 5 months later.
Of 2,089 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's planned 5 months is below that.
Counting every sponsor, half of 2,102 studies reached it within 11 months; a quarter within 6 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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