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

Phase 4

Not yet recruiting

• Conditions: Anterior Cervical Discectomy and Fusion (ACDF)
• Interventions: Drug: Dexmedetomidine in superficial cervical plexus block; Drug: Nalbuphine in superficial cervical plexus block

• Registration Number: NCT06490614
• Lead Sponsor: Kasr El Aini Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2024-06-29
• Status Verified: 2024-07
• Study Start: 2024-07
• Study First Submitted QC: 2024-07-05
• Last Update Submitted: 2024-07-05
• Study First Posted: 2024-07-08
• Last Update Posted: 2024-07-08
• Primary Completion: 2024-10
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine group	Dexmedetomidine in superficial cervical plexus block	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.
Nalbuphine group	Nalbuphine in superficial cervical plexus block	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.

Primary Outcome Measures

Name	Time	Method
The total nalbuphine consumption in mg	The 1st 48 hours starting after patient transfer to the PACU.	The total nalbuphine consumption measured in mg during the 1st 48 hours postoperatively starting after patient transfer to the PACU.

Secondary Outcome Measures

Name	Time	Method
heart rate (beats/min)	At baseline, every half an hour intraoperatively and at 2, 4, 8, 12, 18, 36, and 48 hours postoperatively.	Intraoperative and postoperative heart rate HR (beats/min) in the two groups will be recorded at baseline, every half an hour intraoperatively and at 2, 4, 8, 12, 18, 36, and 48 hours postoperatively.
Postoperative visual analogue scale (VAS) pain score	At 2, 4, 8, 12, 18, and 24 ,36 and 48 hours postoperatively .	Postoperative ( visual analogue scale)VAS pain score , It consists of a 10 cm line with two anchor points zero means'no pain' and 10 is the worst pain imaginable' which is self-assessed by patients.; VAS will be assessed at 2, 4, 8, 12, 18, and 24 ,36 and 48 hours
Time to first postoperative rescue analgesia	Postoperative 48 hours	Time to first postoperative rescue analgesia(nalbuphine in incremental doses of 0.1 mg/kg and not exceeding 0.4 mg/kg in 2 hours) in hours.
Incidence of postoperative complications	Postoperative 48 hours	Incidence of hypotension (MAP\< 25% of baseline), bradycardia (HR\< 50 bpm), respiratory rate \< 10/min or postoperative nausea and vomiting
Mean arterial blood pressure (MAP)	Intraoperatively ,at baseline and every half an hour till the end of surgery, then at 2,4,8,12,18,36 and 48 hours postoperatively.	Mean arterial blood pressure will be recorded intraoperatively and postoperatively at baseline and every half an hour till the end of surgery, then at 2, 4, 8,12,18, 36 and 48 hours postoperatively.
Ramsay Sedation Scale	30 min, 1, 2, 4, 6, and 12, 36 and 48 hours postoperatively.	Ramsay Sedation Scale , which divides a patient's level of sedation into six categories ranging from severe agitation to deep coma. It will be measured at 30 min, 1, 2, 4, 6, and 12, 36 and 48 hours; Ramsay sedation score: Awake level; 1. Anxious and agitated or restless, or both.; 2. Co-operative, oriented, and tranquil.; 3. Responds to commands only. Asleep level; 4. Brisk response to light glabellar tap or loud auditory stimulus.; 5. Sluggish response to light glabellar tap or loud auditory stimulus.; 6. Exhibits no response