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

Not Applicable

Completed

• Conditions: Fentanyl; Dexmedetomidine; Adjuvants; Bupivacaine; Superficial Cervical Plexus Block; Ultrasound; Thyroid Surgeries
• Interventions: Drug: Superficial cervical plexus block; Drug: Superficial cervical plexus block + Fentanyl; Drug: Superficial cervical plexus block + Dexmedetomidine

• Registration Number: NCT07057739
• Lead Sponsor: Kafrelsheikh University

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.

Detailed Description

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.

Study Timeline

• Study Start: 2024-06-30
• Primary Completion: 2025-05-30
• Study Completion: 2025-05-30
• Study First Submitted: 2025-06-17
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-05
• Last Update Submitted: 2025-07-05
• Study First Posted: 2025-07-10
• Last Update Posted: 2025-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C (Control)	Superficial cervical plexus block	Patients received superficial cervical plexus block with 1 ml of normal saline with 7ml bupivacaine 0.25% per side without adjuvants.
Group F (Fentanyl)	Superficial cervical plexus block + Fentanyl	Patients received superficial cervical plexus block with fentanyl 1 ml (50 microgram) as an adjuvant to 7ml bupivacaine 0.25% per side.
Group D (Dexmedetomidine)	Superficial cervical plexus block + Dexmedetomidine	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.

Primary Outcome Measures

Name	Time	Method
Pain degree	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 Outcome Measures

Name	Time	Method
Duration of Sensory Block	24 hours postoperatively	Time from performance of the superficial cervical plexus block to the complete resolution of sensory blockade was assessed.
Time to First Rescue Analgesia	48 hours postoperatively	Time from end of surgery to the administration of the first dose of rescue analgesia, triggered by VAS score ≥3.
Total Opioid Consumption	48 hours postoperatively	Cumulative dose of opioid analgesics (pethidine in mg) administered during the first 48 hours postoperatively.
Mean arterial pressure (MAP)	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.
Heart rate	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.
Incidence of Adverse Events	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.

Trial Locations

Locations (1)

Kafr Elsheikh University; 🇪🇬 Kafr Ash Shaykh, Kafr Elsheikh, Egypt