FentanylNCT07057739
Fentanyl and Dexmedetomidine as Adjuvants to Bupivacaine in Ultrasound-guided Superficial Cervical Plexus Block in Thyroid Surgeries
A study testing Superficial cervical plexus block, Superficial cervical plexus block + Fentanyl and Superficial cervical plexus block + Dexmedetomidine in people with Fentanyl and Dexmedetomidine, run by Kafrelsheikh University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Fentanyl, Dexmedetomidine, Adjuvants
- What is being tested?
- Superficial cervical plexus block, Superficial cervical plexus block + Fentanyl and Superficial cervical plexus block + Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jun 2024to 30 May 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient's approval.
- Aged 20-65 years
- American Society of Anesthesiologists (ASA) physical status I or II
- Undergoing thyroid surgery
- Euthyroid patients
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Superficial cervical plexus block, Superficial cervical plexus block + Fentanyl, Superficial cervical plexus block + Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superficial cervical plexus blockDrug
Also called Bupivacaine 0.25% + Saline
Patients received superficial cervical plexus block with 1 ml of normal saline with 7ml bupivacaine 0.25% per side without adjuvants.
Superficial cervical plexus block + FentanylDrug
Also called Bupivacaine 0.25% + Fentanyl
Patients received superficial cervical plexus block with fentanyl 1 ml (50 microgram) as an adjuvant to 7ml bupivacaine 0.25% per side.
Superficial cervical plexus block + DexmedetomidineDrug
Also called Bupivacaine 0.25% + 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Superficial cervical plexus block + Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours postoperatively
Secondary outcomes (6)
Duration of Sensory Block
Time from performance of the superficial cervical plexus block to the complete resolution of sensory blockade was assessed.
Measured: 24 hours postoperatively
Time to First Rescue Analgesia
Time from end of surgery to the administration of the first dose of rescue analgesia, triggered by VAS score ≥3.
Measured: 48 hours postoperatively
Total Opioid Consumption
Cumulative dose of opioid analgesics (pethidine in mg) administered during the first 48 hours postoperatively.
Measured: 48 hours postoperatively
Mean arterial pressure (MAP)
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.
Measured: 24 hours postoperatively
Heart rate
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.
Measured: 24 hours postoperatively
Incidence of Adverse Events
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.
Measured: 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start30 Jun 2024
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FentanylStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adel Abd Elmoaty Basyouni Elabd, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07057739
- Sponsor's protocol ID
- KFSIRB200-186
- Status last verified
- Jul 2025
- First submitted
- 17 Jun 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.