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

ConditionAnterior Cervical Discectomy and Fusion (ACDF)
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age21-60
SponsorKasr El Aini Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexmedetomidine in superficial cervical plexus block

    Drug

    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.

  • Nalbuphine in superficial cervical plexus block

    Drug

    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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Dexmedetomidine groupExperimental treatment 1 intervention
Group B: Nalbuphine groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
The 1st 48 hours starting after patient transfer to the PACU.

Secondary outcomes

1

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

Time frame
At 2, 4, 8, 12, 18, and 24 ,36 and 48 hours postoperatively .
2

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.

Time frame
Postoperative 48 hours
3

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.

Time frame
At baseline, every half an hour intraoperatively and at 2, 4, 8, 12, 18, 36, and 48 hours postoperatively.
4

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

Time frame
30 min, 1, 2, 4, 6, and 12, 36 and 48 hours postoperatively.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kasr El Aini Hospital

Lead sponsor

Source ClinicalTrials.gov

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