Efficacy of Adding Dexmedetomidine in Ultrasound-guided Intermediate Cervical Plexus Block for Thyroidectomy Surgery

NCT05814744 | Completed

• 1 other identifier: AP2211-301-045
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The cervical plexus block (CPB) is one such block used to provide effective anesthesia and analgesia for surgery in the head and neck region. The cervical fascia was first described as a very strong and resisting structure, consisting of two layers, superficial and deep. But more recently classified the cervical fascia as superficial/subcutaneous and deep. The deep cervical fascia is further divided into three layers: (a) the superficial layer, which was also called the investing fascia but is now referred to as the masticator fascia, submandibular fascia or sternocleidomastoid (SCM)-trapezius fascia, (b) the middle layer, which is suggested as to be named as strap muscle fascia or visceral fascia; and (c) the deep layer or the 'prevertebral fascia'. Intermediate cervical plexus block (CPB) has been found to be very effective in procedures of neck such as thyroid surgeries and carotid endarterectomy. The duration of analgesia following the nerve blocks is a matter of concern as most of the blocks last for only a few hours. Interestingly, resurgence of the use of α2-agonists in combination with local anesthetics has dramatically improved the duration of action of these blocks. Dexmedetomidine is a potent α2 agonist and is now emerging as an adjuvant to regional anesthesia and analgesia. Little evidence is available supporting the usefulness of dexmedetomidine in bilateral intermediate CPB. Therefore, the current study will be conducted to compare the duration and effectiveness of post-thyroidectomy analgesia of bilateral intermediate CPB using 20 ml bupivacaine 0.25% (Group A) or 20 ml of bupivacaine 0.25% with 1 μg/kg dexmedetomidine (Group B).

Conditions

Pain, Postoperative; Cancer of Larynx

Keywords

Intermediate Cervical Plexus Block; dexmedetomidine; bupivacaine; Thyroidectomy surgery

Outcome Measures

Primary Outcomes (1)

• first rescue analgesia

  First time (minutes) opioids requested postoperative when pain score is \>3 .

  the first 24 hours of postoperative period

Secondary Outcomes (4)

• Total intraoperative fentanyl consumption.

  throughout the duration of the surgery

• postoperative opioids consumption.

  24 hours postoperative

• Post-operative pain scores.

  immediately postoperative (0 hours ), 2, 4, 6, 12 and 24 hours postoperative

• Any complications will be recorded.

  throughout the duration of the surgery and 24 hours postoperative

Study Arms (2)

Group (A)

SHAM COMPARATOR

bupivacaine 0.25% only

Drug: bupivacaine 0.25%; Procedure: Thyroidectomy Surgery; Procedure: Ultrasound-guided intermediate Cervical Plexus Block Technique

Group (B)

ACTIVE COMPARATOR

bupivacaine 0.25% and dexmedetomidine

Drug: dexmedetomidine; Drug: bupivacaine 0.25%; Procedure: Thyroidectomy Surgery; Procedure: Ultrasound-guided intermediate Cervical Plexus Block Technique

Interventions

dexmedetomidine DRUG

adding dexmedetomidine as adjuvant with bupivacaine in Ultrasound-guided Intermediate Cervical Plexus Block for Thyroidectomy surgery.

Also known as: precedex vial

Group (B)

bupivacaine 0.25% DRUG

patients will receive bilateral Intermediate Cervical plexus block with 20 ml bupivacaine 0.25%.

Also known as: Sensorcaine®

Group (A); Group (B)

Thyroidectomy Surgery PROCEDURE

surgical removal of all or part of thyroid gland.

Group (A); Group (B)

Ultrasound-guided intermediate Cervical Plexus Block Technique PROCEDURE

the injection of local anesthetic in intermediate cervical plexus nerve block is made between the investing layer of the deep cervical fascia and the prevertebral fascia. Following negative aspiration, 1-2 mL of local anesthetic is injected to confirm the proper injection site.

Group (A); Group (B)

Eligibility Criteria

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

You may qualify if:

• Physical status American society Anesthesiologists ASA II and III.
• Age ≥ 18 and ≤ 60 Years.
• Patient undergoing thyroidectomy for cancer surgery.

You may not qualify if:

• Patient refusal.
• Known sensitivity or contraindication to local anesthetics or dexmedetomidine.
• History of psychological disorders.
• Retro-sternal goiter and altered anatomical landmarks.
• Localized infection at the site of block.
• Coagulopathy with international normalized ratio (INR) ≥ 1.6: hereditary (e.g., hemophilia, fibrinogen abnormalities \& deficiency of factor II) - acquired (e.g., impaired liver functions with prothrombin concentration less than 60 %, vitamin K deficiency \& therapeutic anticoagulants drugs).

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National Cancer Institue

Cairo, Fom El Khalig, 11796, Egypt

Location

Related Publications (7)

• Syal K, Chandel A, Goyal A, Sharma A. Comparison of ultrasound-guided intermediate vs subcutaneous cervical plexus block for postoperative analgesia in patients undergoing total thyroidectomy: A randomised double-blind trial. Indian J Anaesth. 2020 Jan;64(1):37-42. doi: 10.4103/ija.IJA_483_19. Epub 2020 Jan 7.

  PMID: 32001907 BACKGROUND

• Natale G, Condino S, Stecco A, Soldani P, Belmonte MM, Gesi M. Is the cervical fascia an anatomical proteus? Surg Radiol Anat. 2015 Nov;37(9):1119-27. doi: 10.1007/s00276-015-1480-1. Epub 2015 May 7.

  PMID: 25946970 BACKGROUND

• Guidera AK, Dawes PJ, Fong A, Stringer MD. Head and neck fascia and compartments: no space for spaces. Head Neck. 2014 Jul;36(7):1058-68. doi: 10.1002/hed.23442. Epub 2014 Jan 29.

  PMID: 23913739 BACKGROUND

• Kim, J.-S. and H.Y. Kim, Cervical plexus block. Surgical Anatomy of the Cervical Plexus and its Branches, 2022: p. 189-202.

  BACKGROUND

• Egan RJ, Hopkins JC, Beamish AJ, Shah R, Edwards AG, Morgan JD. Randomized clinical trial of intraoperative superficial cervical plexus block versus incisional local anaesthesia in thyroid and parathyroid surgery. Br J Surg. 2013 Dec;100(13):1732-8. doi: 10.1002/bjs.9292.

  PMID: 24227357 BACKGROUND

• Kaygusuz K, Kol IO, Duger C, Gursoy S, Ozturk H, Kayacan U, Aydin R, Mimaroglu C. Effects of adding dexmedetomidine to levobupivacaine in axillary brachial plexus block. Curr Ther Res Clin Exp. 2012 Jun;73(3):103-11. doi: 10.1016/j.curtheres.2012.03.001.

  PMID: 24648597 BACKGROUND

• Andersen JH, Grevstad U, Siegel H, Dahl JB, Mathiesen O, Jaeger P. Does Dexmedetomidine Have a Perineural Mechanism of Action When Used as an Adjuvant to Ropivacaine?: A Paired, Blinded, Randomized Trial in Healthy Volunteers. Anesthesiology. 2017 Jan;126(1):66-73. doi: 10.1097/ALN.0000000000001429.

  PMID: 27792047 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Laryngeal Neoplasms

Interventions

Dexmedetomidine; Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Gehan M. Kamal, Prof.

  National Cancer Institute, Anesthesia, Pain Relief and ICU Department

  PRINCIPAL INVESTIGATOR

• Mohamed E. Hassan, Ass. Prof.

  National Cancer Institute, Anesthesia, Pain Relief and ICU Department

  PRINCIPAL INVESTIGATOR

• Mai M. Elrawas, Doctor

  National Cancer Institute, Anesthesia, Pain Relief and ICU Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: April 18, 2023
• Study Start: April 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: November 1, 2023
• Last Updated: April 5, 2024

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)