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

NCT06490614 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: MS-568-2023
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anterior Cervical Discectomy and Fusion (ACDF)

Outcome Measures

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.

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

Secondary Outcomes (6)

• Postoperative visual analogue scale (VAS) pain score

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

• Time to first postoperative rescue analgesia

  Postoperative 48 hours

• heart rate (beats/min)

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

• Ramsay Sedation Scale

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

• Incidence of postoperative complications

  Postoperative 48 hours

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

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

Nalbuphine group

EXPERIMENTAL

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

Interventions

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.

Also known as: Percedex

Dexmedetomidine group

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.

Also known as: Nalufin

Nalbuphine group

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Related Publications (16)

• Rostami M, Moghadam N, Obeid I, Jouibari MF, Zarei M, Moosavi M, Khoshnevisan A, Farahbakhsh F, Moosaie F, Ehteshami S, Borghei A, Shafizadeh M, Kordi R, Khadivi M. The Impact of Single-Level Anterior Cervical Discectomy and Fusion on Cervical Sagittal Parameters and Its Correlation With Pain and Functional Outcome of Patients With Neck Pain. Int J Spine Surg. 2021 Oct;15(5):899-905. doi: 10.14444/8115. Epub 2021 Oct 8.

  PMID: 34625454 BACKGROUND

• McGirt MJ, Rossi V, Peters D, Dyer H, Coric D, Asher AL, Pfortmiller D, Adamson T. Anterior Cervical Discectomy and Fusion in the Outpatient Ambulatory Surgery Setting: Analysis of 2000 Consecutive Cases. Neurosurgery. 2020 Mar 1;86(3):E310-E315. doi: 10.1093/neuros/nyz514.

  PMID: 31819994 BACKGROUND

• Garringer SM, Sasso RC. Safety of anterior cervical discectomy and fusion performed as outpatient surgery. J Spinal Disord Tech. 2010 Oct;23(7):439-43. doi: 10.1097/BSD.0b013e3181bd0419.

  PMID: 20087224 BACKGROUND

• Arnold PM, Rice LR, Anderson KK, McMahon JK, Connelly LM, Norvell DC. Factors affecting hospital length of stay following anterior cervical discectomy and fusion. Evid Based Spine Care J. 2011 Aug;2(3):11-8. doi: 10.1055/s-0030-1267108.

  PMID: 23532355 BACKGROUND

• Mariappan R, Mehta J, Massicotte E, Nagappa M, Manninen P, Venkatraghavan L. Effect of superficial cervical plexus block on postoperative quality of recovery after anterior cervical discectomy and fusion: a randomized controlled trial. Can J Anaesth. 2015 Aug;62(8):883-90. doi: 10.1007/s12630-015-0382-3. Epub 2015 Apr 14.

  PMID: 25869024 BACKGROUND

• Woldegerima YB, Hailekiros AG, Fitiwi GL. The analgesic efficacy of bilateral superficial cervical plexus block for thyroid surgery under general anesthesia: a prospective cohort study. BMC Res Notes. 2020 Jan 28;13(1):42. doi: 10.1186/s13104-020-4907-7.

  PMID: 31992341 BACKGROUND

• Mulcahy MJ, Elalingam T, Jang K, D'Souza M, Tait M. Bilateral cervical plexus block for anterior cervical spine surgery: study protocol for a randomised placebo-controlled trial. Trials. 2021 Jun 29;22(1):424. doi: 10.1186/s13063-021-05377-4.

  PMID: 34187541 BACKGROUND

• Hassan AH, Amer IA, Abdelkareem AM. Comparative study between dexmedetomidine versus dexamethasone as adjuvants to levobupivacaine for cervical plexus block in patients undergoing thyroid operation. prospective-randomized clinical trial. The Egyptian Journal of Hospital Medicine. 2021 Jul 1;84(1):1638-43.

  BACKGROUND

• Al-Mustafa MM, Abu-Halaweh SA, Aloweidi AS, Murshidi MM, Ammari BA, Awwad ZM, Al-Edwan GM, Ramsay MA. Effect of dexmedetomidine added to spinal bupivacaine for urological procedures. Saudi Med J. 2009 Mar;30(3):365-70.

  PMID: 19271064 BACKGROUND

• Vuyk J, Sitsen E, Reekers M. Intravenous Anesthetics. In: Miller RD, Eriksson LI, Cohen NH, Fleisher LA, Wiener-Kronish JP, Young WL, editors. Miller's Anesthesia. 8th ed. Philadelphia: Elsevier Churchill Livingstone; 2015. pp. 854-9

  BACKGROUND

• Brummett CM, Hong EK, Janda AM, Amodeo FS, Lydic R. Perineural dexmedetomidine added to ropivacaine for sciatic nerve block in rats prolongs the duration of analgesia by blocking the hyperpolarization-activated cation current. Anesthesiology. 2011 Oct;115(4):836-43. doi: 10.1097/ALN.0b013e318221fcc9.

  PMID: 21666435 BACKGROUND

• Richard B, Alan JR, Vincent WS, Miller RD, Eriksson LI, Wiener-Kronish JP, Young WL. Spinal, epidural, and caudal anesthesia. Miller's anesthesia. 8th ed. Philadelphia, PA: Saunders, an imprint of Elsevier Inc. 2015:1684-720.

  BACKGROUND

• Omar Mostafa M, Makram Botros J, Sayed Khaleel AM. Effect of Dexmedetomidine Versus Nalbuphine as an Adjuvant on Paravertebral Block to Manage Postoperative Pain After Mastectomies. Anesth Pain Med. 2018 Apr 28;8(2):e13308. doi: 10.5812/aapm.13308. eCollection 2018 Apr.

  PMID: 30027066 BACKGROUND

• Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge JH, Fainsinger R, Aass N, Kaasa S; European Palliative Care Research Collaborative (EPCRC). Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage. 2011 Jun;41(6):1073-93. doi: 10.1016/j.jpainsymman.2010.08.016.

  PMID: 21621130 BACKGROUND

• Chinnappa V, Chung F.What Criteria Should Be Used for Discharge after Outpatient Surgery?. InEvidence-Based Practice of Anesthesiology 2013 Jan 1 (pp. 343-351).

  BACKGROUND

• Shi W, Dong J, Chen JF, Yu H. A meta-analysis showing the quantitative evidence base of perineural nalbuphine for wound pain from upper-limb orthopaedic trauma surgery. Int Wound J. 2023 May;20(5):1476-1490. doi: 10.1111/iwj.14002. Epub 2022 Nov 3.

  PMID: 36330591 BACKGROUND

MeSH Terms

Interventions

Dexmedetomidine; Nalbuphine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Doaa F El Hamalawy, Lecturer

  Kasr Al-Aini hospital-Faculty of Medicine- Cairo University

  STUDY DIRECTOR

Central Study Contacts

Amira M Mohamed, Resident

CONTACT

+20 1285223474; amiraa485.m@gmail.com

Doaa F El Hamalawy, Lecturer

CONTACT

+20 1151518514; Fz.doaa@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia,surgical ICU and pain management

Model Details: 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).

Study Record Dates

• First Submitted: June 29, 2024
• First Posted: July 8, 2024
• Study Start: July 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: November 1, 2024
• Last Updated: July 8, 2024

Record last verified: 2024-07