NCT06490614

Dexmedetomidine and Nalbuphine as Analgesic Adjuvants to Bupivacaine in Superficial Cervical Block.

Comparative Study Between Dexmedetomidine and Nalbuphine as Analgesic Adjuvants to Bupivacaine in Superficial Cervical Block for Patients Undergoing Anterior Cervical Discectomy and Fusion (ACDF) Surgery A Double Blinded Randomized Trial

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Kasr El Aini Hospital · Academic / Other
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Anterior cervical discectomy and fusion (ACDF) nowadays is considered a common procedure.postoperative pain can hinder recovery and prolong hospital stay. The superficial cervical plexus block (SCPB) is a safe and simple technique that had been found to allow good pain relief in neck surgeries. The main drawback of SCPB was short duration, so adjuvants as dexmedetomidine and opioids has been used to increase analgesic duration and decrease the use of opioids. The current study will compare the efficacy of dexmedetomidine and nalbuphine as adjuvants to bupivacaine in SCPB in anterior cervical fusion surgeries.

Detailed description

The aim of the current study is to evaluate whether the addition of Dexmedetomidine to bupivacaine is comparable to the addition of nalbuphine in superficial cervical plexus block in patients undergoing ACDF. thrity patients will be recruited. Patients will be divided randomly into either group A in which patients will receive SCPB consisting of bupivacaine 0.25%, dexmedetomidine 1 μg/kg (precedex 100mcg/ml), and adrenaline 1:200,000 in a total volume of 10ml normal saline, or Group B in which patients will receive SCPB consisting of bupivacaine 0.25% and 10 mg of Nalbuphine (nalufin 20mg/ml) and adrenaline 1:200,000 in a total volume of 10ml normal saline.

Conditions

• Anterior Cervical Discectomy and Fusion (ACDF)

Interventions

Type	Name	Description
DRUG	Dexmedetomidine in superficial cervical plexus block	While the patient is in the supine position, the head will be turned to the opposite side of the surgical incision, and a line extending from the mastoid process to the clavicular head of the sternomastoid muscle will be marked. Aseptic preparation of this area will be done, and then the block needle will be inserted at the midpoint of this line with injection of bupivacaine 0.25%, dexmedetomidine 1 μg/kg (precedex 100mcg/ml), and adrenaline 1:200,000 in a total volume of 10ml normal saline in the above, below, and middle directions subcutaneously, creating a sausage-shaped swelling. The sensory block will be assessed with ice chips in the dermatome corresponding to the block, which included the skin of the neck, upper chest, shoulder, and ear, until the completion of the sensory blockade.
DRUG	Nalbuphine in superficial cervical plexus block	While the patient is in the supine position, the head will be turned to the opposite side of the surgical incision, and a line extending from the mastoid process to the clavicular head of the sternomastoid muscle will be marked. Aseptic preparation of this area will be done, and then the block needle will be inserted at the midpoint of this line with injection of bupivacaine 0.25%, 10 mg of Nalbuphine (nalufin 20mg/ml), and adrenaline 1:200,000 in a total volume of 10ml normal saline in the above, below, and middle directions subcutaneously, creating a sausage-shaped swelling. The sensory block will be assessed with ice chips in the dermatome corresponding to the block, which included the skin of the neck, upper chest, shoulder, and ear, until the completion of the sensory blockade.

Timeline

• Start date: 2024-07-01
• Primary completion: 2024-10-01
• Completion: 2024-11-01
• First posted: 2024-07-08
• Last updated: 2024-07-08

Regulatory

• FDA-regulated drug study