An interventional study of Bupivacaine 0.25% and Bupivacaine 0.25% + Fentanyl 1µg/kg in Fentanyl, Dexmedetomidine and Bupivacaine, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 21 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Tanta University · Not applicable, Interventional, and Treatment
This study aimed to evaluate the effect of fentanyl versus dexmedetomidine as adjuvants to bupivacaine with comparison to bupivacaine alone in ultrasound-guided erector spinae plane block on the quality and duration of pain control in patients undergoing arthroscopic shoulder surgeries.
Shoulder arthroscopic surgery is one of the most common surgical procedures performed in daily practice, for many surgical indications as rotator cuff tears, stiffness and instability, this procedure has a well - documented postoperative pain.
The erector spinae plane block (ESPB) is one of the emerging regional techniques for managing postoperative pain. ESPB has been used successfully in many surgeries such as mastectomy, thoracotomies, percutaneous nephrolithotomies, lumbar fusions, hernia repair, cesarean delivery and even in total hip arthroplasty.
Fentanyl as an additive to 0.25% bupivacaine in paravertebral block has been found to reduce the rescue analgesic consumption as well as cumulative pain scores at rest and on movement after breast surgery.
Dexmedetomidine is highly selective than clonidine, specific and potentα2-adrenergic agonist having analgesic, sedative, antihypertensive, and anesthetic sparing effects when used in systemic route.
Tanta University is the lead sponsor of 1,010 studies on the registry; 321 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
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.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
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.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients received ultrasound-guided erector spinae plane block (ESPB) using 20 cc of 0.25% bupivacaine at T2.
Drug: Bupivacaine 0.25%
Patients received ultrasound-guided erector spinae plane block (ESPB) using a total volume of 20 ml (bupivacaine 0.25% + Fentanyl 1µg/kg) at T2.
Drug: Bupivacaine 0.25% + Fentanyl 1µg/kg
Patients received ultrasound-guided erector spinae plane block (ESPB) using a total volume of 20 ml (bupivacaine 0.25% + dexmedetomidine 1µg/kg) at T2.
Drug: Bupivacaine 0.25% + dexmedetomidine 1µg/kg
Patients received ultrasound-guided erector spinae plane block (ESPB) using 20 cc of 0.25% bupivacaine at T2.
Drug page: Bupivacaine
Patients received ultrasound-guided erector spinae plane block (ESPB) using a total volume of 20 ml (bupivacaine 0.25% + Fentanyl 1µg/kg) at T2.
Drug page: Bupivacaine
Patients received ultrasound-guided erector spinae plane block (ESPB) using a total volume of 20 ml (bupivacaine 0.25% + dexmedetomidine 1µg/kg) at T2.
Degree of pain
Assessment of postoperative pain was done with numerical rate scale \[numerical rate score (NRS); 0=no pain and 10=worst possible pain\]. At post-anesthesia care unit (PACU) then 2, 4, 6, 8, 12, and 24 hours postoperative.
Time frame: 24 hours postoperatively
Time of first rescue analgesia
Time of first rescue analgesia was recorded from the end of surgery till the first dose of morphine adminstrated.
Time frame: 24 hours postoperatively
Intraoperative fentanyl consumption
Any intraoperative hypertension (mean arterial pressure\>20% of baseline) or tachycardia were managed by rescue fentanyl dose 1µg /kg IV when suspected to be caused by intraoperative pain awareness and these cases was recorded.
Time frame: Intraoperatively
Total amount of morphine consumption
Rescue analgesia in the form of 3 mg IV morphine was given if the numerical rate score (NRS) is ≥ 4 repeated with 10 minutes lockout interval till the (NRS) becomes less than 3.
Time frame: 24 hours postoperatively
Length of hospital stay
Length of hospital stay was recorded from the admission till the discharge from hospital.
Time frame: Till the discharge from hospital (Up to 2 weeks)
Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Supporting information: Study protocol
Time frame: After the end of study for one year.
Access criteria: The data will be available upon a reasonable request from the corresponding author.
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Bupivacaine