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

NCT ID: NCT07057739

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2025-05-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group C (Control)

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

Group Type: EXPERIMENTAL

Superficial cervical plexus block

Intervention Type: DRUG

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

Group F (Fentanyl)

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

Group Type: EXPERIMENTAL

Superficial cervical plexus block + Fentanyl

Intervention Type: DRUG

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)

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.

Group Type: EXPERIMENTAL

Superficial cervical plexus block + Dexmedetomidine

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Bupivacaine 0.25% + Saline; Bupivacaine 0.25% + Fentanyl; Bupivacaine 0.25% + Dexmedetomidine

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kafrelsheikh University

OTHER

Sponsor Role: lead

Responsible Party

Adel Abd Elmoaty Basyouni Elabd

Resident at Anaesthesia, Surgical Intensive Care and Pain Management , Faculty of Medicine, Kafr Elsheikh University Kafr Elsheikh, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kafr Elsheikh University

Kafr ash Shaykh, Kafr Elsheikh, Egypt

Countries

Egypt

Other Identifiers

KFSIRB200-186

Identifier Type: -

Identifier Source: org_study_id