FentanylNCT07836595
Fentanyl Vs Dexmedetomidine as Adjuvants to Bupivacaine in Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Arthroscopic Shoulder Surgeries
A study testing Bupivacaine 0.25%, Bupivacaine 0.25% + Fentanyl 1µg/kg and Bupivacaine 0.25% + dexmedetomidine 1µg/kg in people with Fentanyl and Dexmedetomidine, run by Tanta University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Fentanyl, Dexmedetomidine, Bupivacaine
- What is being tested?
- Bupivacaine 0.25%, Bupivacaine 0.25% + Fentanyl 1µg/kg and Bupivacaine 0.25% + dexmedetomidine 1µg/kg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 Dec 2024
- Phase
- Interventional
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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both sexes.
- Age from 21 to 60 years.
- Belonging to American Society of Anesthesiologists (ASA) physical status I and II.
- Underwent shoulder arthroscopic surgery.
Who cannot join
- Patients who were known to have an allergy to amide type local anesthetics, dexmedetomidine, or fentanyl.
- Patients who were receiving non-steroidal anti-inflammatory drugs or any chronic drugs for pain management in the past four weeks.
- Had a history of drug dependency or substance addiction.
- Body mass index (BMI) of 18.5 or higher.
- Had a severe spinal deformity.
- Had an uncontrolled concomitant medical condition.
- Had a local skin infection at the injection site or spinal metastasis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Fentanyl Vs Dexmedetomidine as Adjuvants to Bupivacaine in Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Arthroscopic Shoulder Surgeries
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.
Read the detailed description
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.
- Conditions
- Fentanyl, Dexmedetomidine, Bupivacaine, Erector Spinae Plane Block, Postoperative Analgesia, Arthroscopic Shoulder Surgeries
- Being tested
- Bupivacaine 0.25%, Bupivacaine 0.25% + Fentanyl 1µg/kg, Bupivacaine 0.25% + dexmedetomidine 1µg/kg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine 0.25%Drug
Patients received ultrasound-guided erector spinae plane block (ESPB) using 20 cc of 0.25% bupivacaine at T2.
Bupivacaine 0.25% + Fentanyl 1µg/kgDrug
Patients received ultrasound-guided erector spinae plane block (ESPB) using a total volume of 20 ml (bupivacaine 0.25% + Fentanyl 1µg/kg) at T2.
Bupivacaine 0.25% + dexmedetomidine 1µg/kgDrug
Patients received ultrasound-guided erector spinae plane block (ESPB) using a total volume of 20 ml (bupivacaine 0.25% + dexmedetomidine 1µg/kg) at T2.
| Study group | Role | What they receive |
|---|---|---|
| ESPB with bupivacaine alone | Active comparator | Patients received ultrasound-guided erector spinae plane block (ESPB) using 20 cc of 0.25% bupivacaine at T2. Receives: Drug: Bupivacaine 0.25% |
| ESPB with Fentanyl group | Experimental | Patients received ultrasound-guided erector spinae plane block (ESPB) using a total volume of 20 ml (bupivacaine 0.25% + Fentanyl 1µg/kg) at T2. Receives: Drug: Bupivacaine 0.25% + Fentanyl 1µg/kg |
| ESPB with Dexmedetomidine group | Experimental | Patients received ultrasound-guided erector spinae plane block (ESPB) using a total volume of 20 ml (bupivacaine 0.25% + dexmedetomidine 1µg/kg) at T2. Receives: Drug: Bupivacaine 0.25% + dexmedetomidine 1µg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours postoperatively
Secondary outcomes (4)
Time of first rescue analgesia
Time of first rescue analgesia was recorded from the end of surgery till the first dose of morphine adminstrated.
Measured: 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.
Measured: 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.
Measured: 24 hours postoperatively
Length of hospital stay
Length of hospital stay was recorded from the admission till the discharge from hospital.
Measured: Till the discharge from hospital (Up to 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start1 Jan 2024
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FentanylStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mohsen Kamel Sheta, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836595
- Sponsor's protocol ID
- 36265MD170/11/23
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- 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.