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

July 5, 2024 updated by: Doaa Fawzy Abd El Fattah Hassan, Kasr El Aini Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexmedetomidine group
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.
Drug: Dexmedetomidine in superficial cervical plexus block
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
Experimental: Nalbuphine group
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.
Drug: Nalbuphine in superficial cervical plexus block
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The 1st 48 hours starting after patient transfer to the PACU.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At 2, 4, 8, 12, 18, and 24 ,36 and 48 hours postoperatively .
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.
Postoperative 48 hours
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.
At baseline, every half an hour intraoperatively and at 2, 4, 8, 12, 18, 36, and 48 hours postoperatively.
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

  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
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
Postoperative 48 hours
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kasr El Aini Hospital

Investigators

  • Study Director: Doaa F El Hamalawy, Lecturer, Kasr Al-Aini hospital-Faculty of Medicine- Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

June 29, 2024

First Submitted That Met QC Criteria

July 5, 2024

First Posted (Actual)

July 8, 2024

Study Record Updates

Last Update Posted (Actual)

July 8, 2024

Last Update Submitted That Met QC Criteria

July 5, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS-568-2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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