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

NCT07836595 | Completed

• 1 other identifier: 36265MD170/11/23
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fentanyl; Dexmedetomidine; Bupivacaine; Postoperative Analgesia; Arthroscopic Shoulder Surgeries; Erector Spinae Plane Block

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours postoperatively

Secondary Outcomes (4)

• Time of first rescue analgesia

  24 hours postoperatively

• Intraoperative fentanyl consumption

  Intraoperatively

• Total amount of morphine consumption

  24 hours postoperatively

• Length of hospital stay

  Till the discharge from hospital (Up to 2 weeks)

Study Arms (3)

ESPB with bupivacaine alone

ACTIVE COMPARATOR

Patients received ultrasound-guided erector spinae plane block (ESPB) using 20 cc of 0.25% bupivacaine at T2.

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.

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.

Drug: Bupivacaine 0.25% + dexmedetomidine 1µg/kg

Interventions

Bupivacaine 0.25% DRUG

Patients received ultrasound-guided erector spinae plane block (ESPB) using 20 cc of 0.25% bupivacaine at T2.

ESPB with bupivacaine alone

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.

ESPB with Fentanyl group

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.

ESPB with Dexmedetomidine group

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Interventions

Bupivacaine; Fentanyl; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazoles; Azoles

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 23, 2026
• Study Start: January 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

EG (1)