The Efficacy of Intermediate Cervical Plexus Block Versus Cutaneous and Thyroid Capsular Blocks

The Efficacy of Intermediate Cervical Plexus Block Versus Cutaneous and Thyroid Capsular Blocks in Thyroid Surgeries

Thyroid gland surgery is one of the most commonly performed operations for either benign or malignant pathologies Pain related to thyroid surgery is of moderate intensity .which may be treated with NSAIDs or opioids. However, Opioids have many well-known undesirable effects, including postoperative nausea and vomiting, which are frequent after this type of procedure.

Study Overview

• Status: Completed
• Conditions: Thyroid Surgery
• Intervention / Treatment: Procedure: Capsule and cutaneous blocks; Procedure: US-intermediate cervical plexus block

Detailed Description

Regional techniques of anesthesia may help to decrease post-operative pain and reduce systemic analgesic requirement. Classically, the cervical plexus is considered to have two distributions, the superficial cutaneous and the deep motor nerves.

Anatomically, the thyroid gland has an inner true capsule which is thin and adheres closely to the thyroidal tissue [Fancy et al., 2010]. External to this is a false capsule formed by the middle layer of the deep cervical fascia, which splits anterolaterally to ensheathe the thyroid gland, thus forming the thyroid sheath [Bliss et al., 2000]. In this fashion, the potential space called the capsule-sheath space is formed. It contains also loose connective tissue, blood vessels, nerves and parathyroid gland. Anesthetic deposited in this space would block the surface of thyroid gland and permeate directly into the parenchyma producing effective local anesthesia for thyroid surgical procedures. It is supposed also to involve autonomic nerve block of the thyroid gland [Fliers et al., 2010]. Additionally, a subcutaneous injection along the sternocleidomastoid muscle (SCM) would also enhance effective local anesthesia for the initial skin incision and further contribute to a more ideal working environment for the surgeon. Therefore, anesthetic technique termed ultrasound-guided capsule-sheath space block (CSSB) combined with anterior cervical cutaneous nerves block (CCNB) for thyroidectomy is done [Wang et al., 2015] .

Our hypothesis is that a combination of simple dual techniques including superficial cutaneous block to provide sensory blockade, and surgeon mediated capsular block may afford autonomic thyroid blockade. In comparison, ultrasound guided intermediate cervical plexus block may provide these blocks but using a machine and deep penetration possibly involving unwanted blocks for phrenic and recurrent laryngeal nerves. So, if the simple safe technique can provide the same intra and postoperative anesthetic conditions it will be preferred.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • DK
    • Mansourah, DK, Egypt, 53316
      • Oncolgy Center, Mansoura University,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• American Society of Anesthesiologists physical status grade I and grade II.
• Euthyroidism after thyroid function tests

Exclusion Criteria:

• Patient refusal.
• Thyroid gland more than 5 cm size.
• Retrosternal extension.
• Planned block neck dissection.
• Neuromuscular diseases
• Hematological diseases.
• Bleeding diseases.
• Coagulation abnormality.
• Psychiatric diseases.
• Drug abuse.
• Local skin infection
• sepsis at site of the block.
• Known intolerance to the study drugs.
• Body Mass Index > 40 Kg/m2.
• Known diaphragmatic motion abnormalities
• major respiratory disease.
• Previous history of cervical surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Capsule and cutaneous blocks; 7.5 mL of 0.5% bupivacaine + Epinephrine 5 ug/ ml for both blocks per side. once before surgery	Procedure: Capsule and cutaneous blocks; 7.5 mL of 0.5% bupivacaine + Epinephrine 5 ug/ ml for both blocks once before surgery per side
Active Comparator: US-intermediate cervical plexus block; 15 mL of 0.5% isobaric bupivacaine + Epinephrine 5 microgram/ ml. per side. once before surgery	Procedure: US-intermediate cervical plexus block; 15 mL of 0.5% bupivacaine + Epinephrine 5 ug/ ml once before surgery per side.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total dose of opioid analgesics used	The total dose of opioid analgesics required in the post-operative periods	For 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	Postoperative visual analogue score (VAS) (0 no pain -10 worst imaginable pain),	For 24 hours after surgery
Time to first analgesic request	Time to first request for a rescue analgesic	For 24 hours after surgery
Fentanyl use	Intraoperative use of fentanyl	For 5 hours after start of anaesthesia
Rocuronium use	Intraoperative use of rocuronium	For 5 hours after start of anaesthesia
Sensory blockade	Assessment of sensory blockade	for 1 hour after surgery
Diaphragmatic dysfunction	Diaphragmatic dysfunction using ultrasound assessment and possible x ray	for 5 hours after performing blockade
Sedation score	Sedation score using Modified Ramsay scale	for 5 hours after performing blockade
Patient satisfaction	Patient satisfaction regards analgesia using a score of (0-10) with 10 represents the highest satisfaction	for 24 hrs after surgery
Postoperative nausea and vomiting	frequency	For 24 hours after surgery
Postoperative headache	frequency	For 24 hours after surgery
Hoarseness of voice	frequency	For 24 hours after surgery
Dysphagia	frequency	For 24 hours after surgery
Respiratory difficulty	Peripheral oxygen saturation less than 92%	For 24 hours after surgery

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Moneir O El-Hefny, MD, Professor of Anesthesia and Surgical Intensive Care

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: August 29, 2017
• First Submitted That Met QC Criteria: August 29, 2017
• First Posted (Actual): September 1, 2017

Study Record Updates

• Last Update Posted (Actual): September 22, 2020
• Last Update Submitted That Met QC Criteria: September 19, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases
• Other Study ID Numbers: MS/17.03.138

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No