Dexmedetomidine and Nalbuphine as Analgesic Adjuvants to Bupivacaine in Superficial Cervical Block.
NCT Number: NCT06490614
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Anterior Cervical Discectomy and Fusion (ACDF)
Interventions: DRUG: Dexmedetomidine in superficial cervical plexus block|DRUG: Nalbuphine in superficial cervical plexus block
Sponsor: Kasr El Aini Hospital
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07
Completion Date: 2024-11

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.

Primary Outcome Measures: The total nalbuphine consumption in mg, The total nalbuphine consumption measured in mg during the 1st 48 hours postoperatively starting after patient transfer to the PACU., The 1st 48 hours starting after patient transfer to the PACU.
Secondary Outcome Measures: Postoperative visual analogue scale (VAS) pain score, 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, At 2, 4, 8, 12, 18, and 24 ,36 and 48 hours postoperatively .|Time to first postoperative rescue analgesia, 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., Postoperative 48 hours|heart rate (beats/min), 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., At baseline, every half an hour intraoperatively and at 2, 4, 8, 12, 18, 36, and 48 hours postoperatively.|Ramsay Sedation Scale, 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, 30 min, 1, 2, 4, 6, and 12, 36 and 48 hours postoperatively.|Incidence of postoperative complications, Incidence of hypotension (MAP\< 25% of baseline), bradycardia (HR\< 50 bpm), respiratory rate \< 10/min or postoperative nausea and vomiting, Postoperative 48 hours|Mean arterial blood pressure (MAP), 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., 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.