RecruitingPhase 3Phase 4ACTRN12622000942752

Dexmedetomidine as an adjuvant to levobupivacaine and lidocaine in ultrasound-guided superficial cervical block for carotid endarterectomy: a prospective, randomised, double- blinded study

Duration of sensory block and analgesia when using dexmedetomidine as an adjuvant to levobupivacaine and lidocaine in ultrasound-guided superficial cervical block for carotid endarterectomy: a prospective, randomised, double-blinded study

Sponsor

University hospital centre Sestre Milosrdnice

Enrollment

60 participants

Start Date

Sep 28, 2021

Study Type

Interventional

Conditions

Superficial cervical block for carotid endarterectomy.

Summary

Study hypothesis: Dexmedetomidine increases the duration of sensory block and analgesia when using it as an adjuvant to levobupivacaine and lidocaine in ultrasound-guided superficial cervical block for carotid endarterectomy surgery. Numerous additives were tried in combination with local anaesthetics to increase the quality of anaesthesia and prolong postoperative analgesia. Research on use of a-2 receptor agonist dexmedetomidine as an adjuvant in regional anaesthesia has positive effect on duration of block, but there are no studies on usage in superficial cervical block (SCB) in carotid endarterectomy (CEA), where management of mean arterial pressure is essential. We therefore designed a prospective, randomised, double-blinded study to investigate the effect of adding dexmedetomidine to levobupivacaine and lidocaine on the quality of SCB in CEA surgery.,All patients had invasive blood pressure monitoring and parameters were noted every 5 minutes. Patients were randomly assigned into two groups: both groups received 2 mg/kg 0.5% levobupivacaine with 200 mg of 2% lidocaine supplemented with saline to a volume of 50 mL. Subject group S additionally received 50 micrograms of dexmedetomidine in mixture. The onset and duration of sensory block and analgesia, haemodynamic parameters and side effects: bradycardia, hypotension, respiratory depression, nausea, vomiting, pruritus and shivering were recorded.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 80 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a medication called dexmedetomidine to a standard local anaesthetic nerve block can improve pain relief during and after carotid endarterectomy — a surgery to remove dangerous fatty buildup from the carotid artery in the neck to reduce stroke risk. The nerve block used, called a superficial cervical block, numbs the area around the neck so surgery can be performed with the patient awake rather than under general anaesthesia, which is safer for patients with artery disease. Researchers want to find out whether adding dexmedetomidine (an alpha-2 receptor agonist already used in other nerve blocks) extends the duration of numbness and pain relief after surgery, without causing unwanted side effects such as low blood pressure or slow heart rate. Participants are randomly assigned to receive either the standard local anaesthetic mixture alone or the same mixture with dexmedetomidine added. You may be eligible if you are aged 18–80, have greater than 70% narrowing of a carotid artery requiring surgery, and have an acceptable health status (ASA I–III). People with severe liver disease, extreme obesity (BMI over 40), or known allergies to local anaesthetics are not eligible.

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Interventions

Superficial cervical block (SCB) was performed with 2 mg/kg 0.5% levobupivacaine, 200 mg of 2% lidocaine supplemented with saline to a volume of 50 mL. Subject group S additionally received 50 microg

Superficial cervical block (SCB) was performed with 2 mg/kg 0.5% levobupivacaine, 200 mg of 2% lidocaine supplemented with saline to a volume of 50 mL. Subject group S additionally received 50 micrograms of dexmedetomidine in mixture. The anaesthetist who performes the procedure positioned the patient in supine position, with the head resting on pillow, looking to the opposite side. With the patient in the proper position, the skin was disinfected and the transducer is placed at the midpoint of the sternocleidomastoid muscle. The cervical plexus is identified, the needle is passed with in-plane approach behind the sternocleidomastoid muscle, the tip is placed adjacent to the plexus, and 15mL of local anesthetic mixture is administered. The rest of the local anesthetic mixture (35 mL) was injected subcutaneous cephalad and caudad along the length of the sternocleidomastoid muscle posterior border, and along the lower edge of the body of the mandible. The procedure was performed approximately 30 min prior to the initial surgical incision.

Locations(2)

Croatia

Zagreb, Croatia

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ACTRN12622000942752