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Completed

NCT Number: NCT07836595

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.

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Key information

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Both sexes.
  • Age from 21 to 60 years.
  • Belonging to American Society of Anesthesiologists (ASA) physical status I and II.
  • Underwent shoulder arthroscopic surgery.

Exclusion criteria

  • 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.

Treatment and study plan

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/kg

Drug

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/kg

Drug

Patients received ultrasound-guided erector spinae plane block (ESPB) using a total volume of 20 ml (bupivacaine 0.25% + dexmedetomidine 1µg/kg) at T2.

Primary outcomes

  1. Degree of pain

    Time frame: 24 hours postoperatively

    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.

Secondary outcomes

  1. Time of first rescue analgesia

    Time frame: 24 hours postoperatively

    Time of first rescue analgesia was recorded from the end of surgery till the first dose of morphine adminstrated.

  2. Intraoperative fentanyl consumption

    Time frame: Intraoperatively

    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.

  3. Total amount of morphine consumption

    Time frame: 24 hours postoperatively

    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.

  4. Length of hospital stay

    Time frame: Till the discharge from hospital (Up to 2 weeks)

    Length of hospital stay was recorded from the admission till the discharge from hospital.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Effects of Fentanyl Vs Dexmedetomidine as Adjuvants to Bupivacaine in Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Arthroscopic Shoulder Surgeries

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 23, 2026
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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