Fentanyl and Dexmedetomidine as Adjuvants to Bupivacaine in Ultrasound-guided Superficial Cervical Plexus Block in Thyroid Surgeries

NCT07057739 | Completed

• 1 other identifier: KFSIRB200-186
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to compare the analgesic efficacy between fentanyl and dexmedetomidine as adjuvants to bupivacaine in ultrasound-guided superficial cervical plexus block for thyroid surgeries.

Conditions

Fentanyl; Dexmedetomidine; Adjuvants; Bupivacaine; Ultrasound; Superficial Cervical Plexus Block; Thyroid Surgeries

Outcome Measures

Primary Outcomes (1)

• Pain degree

  Postoperative pain was assessed using a 10-point Visual Analog Scale (VAS), where 0 represents no pain and 10 indicates the worst imaginable pain. It was assessed at 0, 2, 4, 6, 8, 12, 18, and 24 hours post-surgery.

  24 hours postoperatively

Secondary Outcomes (6)

• Duration of Sensory Block

  24 hours postoperatively

• Time to First Rescue Analgesia

  48 hours postoperatively

• Total Opioid Consumption

  48 hours postoperatively

• Mean arterial pressure (MAP)

  24 hours postoperatively

• Heart rate

  24 hours postoperatively

Study Arms (3)

Group C (Control)

EXPERIMENTAL

Patients received superficial cervical plexus block with 1 ml of normal saline with 7ml bupivacaine 0.25% per side without adjuvants.

Drug: Superficial cervical plexus block

Group F (Fentanyl)

EXPERIMENTAL

Patients received superficial cervical plexus block with fentanyl 1 ml (50 microgram) as an adjuvant to 7ml bupivacaine 0.25% per side.

Drug: Superficial cervical plexus block + Fentanyl

Group D (Dexmedetomidine)

EXPERIMENTAL

Patients received superficial cervical plexus block with dexmedetomidine 0.5mcg/kg in 1 ml of normal saline as an adjuvant to 7ml bupivacaine 0.25% per side.

Drug: Superficial cervical plexus block + Dexmedetomidine

Interventions

Superficial cervical plexus block DRUG

Patients received superficial cervical plexus block with 1 ml of normal saline with 7ml bupivacaine 0.25% per side without adjuvants.

Also known as: Bupivacaine 0.25% + Saline

Group C (Control)

Superficial cervical plexus block + Fentanyl DRUG

Patients received superficial cervical plexus block with fentanyl 1 ml (50 microgram) as an adjuvant to 7ml bupivacaine 0.25% per side.

Also known as: Bupivacaine 0.25% + Fentanyl

Group F (Fentanyl)

Superficial cervical plexus block + Dexmedetomidine DRUG

Patients received superficial cervical plexus block with dexmedetomidine 0.5mcg/kg in 1 ml of normal saline as an adjuvant to 7ml bupivacaine 0.25% per side.

Also known as: Bupivacaine 0.25% + Dexmedetomidine

Group D (Dexmedetomidine)

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient's approval.
• Aged 20-65 years
• American Society of Anesthesiologists (ASA) physical status I or II
• Undergoing thyroid surgery
• Euthyroid patients

You may not qualify if:

• Patient refusal.
• Age: \>65 and \<20 years.
• Allergy to Dexmedetomidine, local anesthetics, systemic opioids and any of the drugs included in the multimodal perioperative pain protocol.
• Patient with coagulation disorders.
• Chronic pain syndromes and patients with chronic opioid use are defined as use of regular daily doses of systemic narcotics for the past 6 months prior to the surgery.
• BMI of 35 kg/m2 or more.
• Physical Status: American Society of Anesthesiologists (ASA) III \& IV.
• Local infection or sepsis at the site of injection.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafr Elsheikh University

Kafr ash Shaykh, Kafr Elsheikh, 33516, Egypt

Location

MeSH Terms

Interventions

Bupivacaine; Sodium Chloride; Fentanyl; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazoles; Azoles

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at Anaesthesia, Surgical Intensive Care and Pain Management , Faculty of Medicine, Kafr Elsheikh University Kafr Elsheikh, Egypt.

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: July 10, 2025
• Study Start: June 30, 2024
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: July 10, 2025

Record last verified: 2025-07

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)