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

Kasr El Aini Hospital

Status and phase: Not yet enrolling; Phase 4

Conditions: Anterior Cervical Discectomy and Fusion (ACDF)

Treatments: Drug: Nalbuphine in superficial cervical plexus block; Drug: Dexmedetomidine in superficial cervical plexus block

Study type: Interventional

Funder types: Other

Identifiers

NCT06490614

MS-568-2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 21 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Physical status ASA I and ASA ll.
• Both males and females
• Age 21- 60 years.
• Patients undergoing elective anterior cervical discectomy and fusion for 1 or 2 levels.

Exclusion criteria

• Patient refusal.
• Patients undergoing anterior cervical vertebrectomy and reconstruction.
• Patients with a history of allergy to local anesthetics or any used drugs in study.
• Infection at the site of the block.
• Patients with multiple cervical spine traumas.
• Patients having surgery for malignant tumors.
• Pre-existing peripheral neuropathies.
• Pregnant female.
• Patients with uncontrolled hypertension or cardiac problems as (heart block, sick sinus syndrome and ischemic heart disease).
• Patients with coagulopathy (INR>1.5).
• Patients with failed block.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Dexmedetomidine group

Experimental group

Description:

Patients will be subjected to 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.

Treatment:

Drug: Dexmedetomidine in superficial cervical plexus block

Nalbuphine group

Experimental group

Description:

Patients will be subjected to 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.

Treatment:

Drug: Nalbuphine in superficial cervical plexus block