Clinical trial NCT06490614: Dexmedetomidine and Nalbuphine as Analgesic Adjuvants to Bupivacaine in Superficial Cervical Block.
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Anterior Cervical Discectomy and Fusion (ACDF)
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2024-07-08
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned to one of two groups in parallel for the duration of the study, either group A (Dexmedetomidine group) or group B (nalbuphine group).
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The total nalbuphine consumption in mg
timeFrame: The 1st 48 hours starting after patient transfer to the PACU.
Secondary outcomes:
measure: Postoperative visual analogue scale (VAS) pain score
timeFrame: At 2, 4, 8, 12, 18, and 24 ,36 and 48 hours postoperatively .
measure: Time to first postoperative rescue analgesia
timeFrame: Postoperative 48 hours
measure: heart rate (beats/min)
timeFrame: At baseline, every half an hour intraoperatively and at 2, 4, 8, 12, 18, 36, and 48 hours postoperatively.
measure: Ramsay Sedation Scale
timeFrame: 30 min, 1, 2, 4, 6, and 12, 36 and 48 hours postoperatively.
measure: Incidence of postoperative complications
timeFrame: Postoperative 48 hours
measure: Mean arterial blood pressure (MAP)
timeFrame: 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.
Other outcomes:
Locations:
Study officials:
affiliation: Kasr Al-Aini hospital-Faculty of Medicine- Cairo University
name: Doaa F El Hamalawy, Lecturer
role: STUDY_DIRECTOR
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