Dexmedetomidine and Nalbuphine as Analgesic Adjuvants to Bupivacaine in Superficial Cervical Block.
NCT ID: NCT06490614
Last Updated: 2024-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
30 participants
INTERVENTIONAL
2024-07-31
2024-11-30
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Both males and females
* Age 21- 60 years.
* Patients undergoing elective anterior cervical discectomy and fusion for 1 or 2 levels.
Exclusion Criteria
* 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.
21 Years
60 Years
ALL
No
Sponsors
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Kasr El Aini Hospital
OTHER
Responsible Party
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Doaa Fawzy Abd El Fattah Hassan
Lecturer of anesthesia,surgical ICU and pain management
Principal Investigators
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Doaa F El Hamalawy, Lecturer
Role: STUDY_DIRECTOR
Kasr Al-Aini hospital-Faculty of Medicine- Cairo University
Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
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.
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.
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.
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).
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.
Other Identifiers
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MS-568-2023
Identifier Type: -
Identifier Source: org_study_id
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