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

NCT ID: NCT03269890

Last Updated: 2020-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2018-09-30

Brief 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.

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.

Conditions

Thyroid Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Capsule and cutaneous blocks

7.5 mL of 0.5% bupivacaine + Epinephrine 5 ug/ ml for both blocks per side. once before surgery

Group Type: EXPERIMENTAL

Capsule and cutaneous blocks

Intervention Type: PROCEDURE

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% isobaric bupivacaine + Epinephrine 5 microgram/ ml. per side. once before surgery

Group Type: ACTIVE_COMPARATOR

US-intermediate cervical plexus block

Intervention Type: PROCEDURE

15 mL of 0.5% bupivacaine + Epinephrine 5 ug/ ml once before surgery per side.

Interventions

Capsule and cutaneous blocks

7.5 mL of 0.5% bupivacaine + Epinephrine 5 ug/ ml for both blocks once before surgery per side

Intervention Type: PROCEDURE

US-intermediate cervical plexus block

15 mL of 0.5% bupivacaine + Epinephrine 5 ug/ ml once before surgery per side.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Moneir O El-Hefny, MD

Role: STUDY_CHAIR

Professor of Anesthesia and Surgical Intensive Care

Locations

Oncolgy Center, Mansoura University,

Al Mansurah, DK, Egypt

Countries

Egypt

Other Identifiers

MS/17.03.138

Identifier Type: -

Identifier Source: org_study_id