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NCT Number: NCT07057739

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

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.

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Key information

Conditions

Fentanyl Adjuvants Bupivacaine Dexmedetomidine Superficial Cervical Plexus Block Thyroid Surgeries Ultrasound

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kafr Elsheikh University

Kafr ash Shaykh, Kafr Elsheikh, 33516, Egypt

About this study

Cervical plexus blocks are easy to perform and provide anesthesia for the surgical procedure in the distribution of C2 to C4, including carotid endarterectomies, lymph node dissection, and thyroid surgeries.

Dexmedetomidine (α2 adrenoceptor agonist) is being used for intravenous (IV) sedation and analgesia for intubated and mechanically ventilated patients in Intensive Care Units. Its use in peripheral nerve blocks has recently been described. It has been reported to have a rapid onset time,prolong the duration of local anesthetics, and it is approximately 8 times more potent than clonidine and is also reportedly safe and effective in peripheral nerve blocks.

Opiates are widely known to have an analgesic effect at the central and spinal cord level. However, opioid analgesia can be initiated by activation of peripheral opioid receptors. Opioids such as fentanyl have been used for regional nerve plexus blocks to improve the block duration and quality.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: Bupivacaine 0.25% + Saline

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.

Other names: Bupivacaine 0.25% + 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.

Other names: Bupivacaine 0.25% + Dexmedetomidine

Primary outcomes

  1. Pain degree

    Time frame: 24 hours postoperatively

    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.

Secondary outcomes

  1. Duration of Sensory Block

    Time frame: 24 hours postoperatively

    Time from performance of the superficial cervical plexus block to the complete resolution of sensory blockade was assessed.

  2. Time to First Rescue Analgesia

    Time frame: 48 hours postoperatively

    Time from end of surgery to the administration of the first dose of rescue analgesia, triggered by VAS score ≥3.

  3. Total Opioid Consumption

    Time frame: 48 hours postoperatively

    Cumulative dose of opioid analgesics (pethidine in mg) administered during the first 48 hours postoperatively.

  4. Mean arterial pressure (MAP)

    Time frame: 24 hours postoperatively

    Serial measurement of mean arterial pressure (MAP, mmHg) at baseline, intraoperatively every 30 minutes, and postoperatively at 0, 2, 4, 6, 8, 12, and 24 hours.

  5. Heart rate

    Time frame: 24 hours postoperatively

    Serial measurement of heart rate (beats per minute) at baseline, intraoperatively every 30 minutes, and postoperatively at 0, 2, 4, 6, 8, 12, and 24 hours.

  6. Incidence of Adverse Events

    Time frame: 48 hours postoperatively

    Incidence of adverse events including but not limited to Horner's syndrome, local anesthetic systemic toxicity (LAST), phrenic nerve block, bradycardia, hypotension, hematoma, nausea, vomiting, respiratory discomfort, and failed block was recorded.

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 10, 2025
Registry last updated
Jul 10, 2025

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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