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NCT Number: NCT06490614

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

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.

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Key information

Conditions

Anterior Cervical Discectomy and Fusion (ACDF)

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Percedex

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.

Other names: Nalufin

Primary outcomes

  1. The total nalbuphine consumption in mg

    Time frame: 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 outcomes

  1. Postoperative visual analogue scale (VAS) pain score

    Time frame: 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

  2. Time to first postoperative rescue analgesia

    Time frame: 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.

  3. heart rate (beats/min)

    Time frame: 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.

  4. Ramsay Sedation Scale

    Time frame: 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

    • Anxious and agitated or restless, or both.
    • Co-operative, oriented, and tranquil.
    • Responds to commands only. Asleep level
    • Brisk response to light glabellar tap or loud auditory stimulus.
    • Sluggish response to light glabellar tap or loud auditory stimulus.
    • Exhibits no response

  5. Incidence of postoperative complications

    Time frame: Postoperative 48 hours

    Incidence of hypotension (MAP< 25% of baseline), bradycardia (HR< 50 bpm), respiratory rate < 10/min or postoperative nausea and vomiting

  6. Mean arterial blood pressure (MAP)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amira M Mohamed, Resident

CONTACT

[email protected]

+20 1285223474

Doaa F El Hamalawy, Lecturer

CONTACT

[email protected]

+20 1151518514

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 8, 2024
Registry last updated
Jul 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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