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

Thyroid Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03269890
• Other study ID #: MS/17.03.138
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: September 2020
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: September 30, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Surgery

Intervention

Procedure:
• Capsule and cutaneous blocks
7.5 mL of 0.5% bupivacaine + Epinephrine 5 ug/ ml for both blocks once before surgery per side
• US-intermediate cervical plexus block
15 mL of 0.5% bupivacaine + Epinephrine 5 ug/ ml once before surgery per side.

Locations

Country	Name	City	State
Egypt	Oncolgy Center, Mansoura University,	Mansourah	DK

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

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