Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07057739
Enrollment
60
Registered
2025-07-10
Start date
2024-06-30
Completion date
2025-05-30
Last updated
2025-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

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

DRUGSuperficial 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.

DRUGSuperficial 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.

Sponsors

Kafrelsheikh University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Pain degree24 hours postoperativelyPostoperative 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

MeasureTime frameDescription
Time to First Rescue Analgesia48 hours postoperativelyTime from end of surgery to the administration of the first dose of rescue analgesia, triggered by VAS score ≥3.
Total Opioid Consumption48 hours postoperativelyCumulative dose of opioid analgesics (pethidine in mg) administered during the first 48 hours postoperatively.
Duration of Sensory Block24 hours postoperativelyTime from performance of the superficial cervical plexus block to the complete resolution of sensory blockade was assessed.
Heart rate24 hours postoperativelySerial 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 Events48 hours postoperativelyIncidence 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.
Mean arterial pressure (MAP)24 hours postoperativelySerial 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026