Clinical trial NCT03269890: The Efficacy of Intermediate Cervical Plexus Block Versus Cutaneous and Thyroid Capsular Blocks
Official title: The Efficacy of Intermediate Cervical Plexus Block Versus Cutaneous and Thyroid Capsular Blocks in Thyroid Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Surgery
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2017-09-01
Enrollment: 74
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Total dose of opioid analgesics used
timeFrame: For 24 hours after surgery
Secondary outcomes:
measure: Postoperative pain
timeFrame: For 24 hours after surgery
measure: Time to first analgesic request
timeFrame: For 24 hours after surgery
measure: Fentanyl use
timeFrame: For 5 hours after start of anaesthesia
measure: Rocuronium use
timeFrame: For 5 hours after start of anaesthesia
measure: Sensory blockade
timeFrame: for 1 hour after surgery
measure: Diaphragmatic dysfunction
timeFrame: for 5 hours after performing blockade
measure: Sedation score
timeFrame: for 5 hours after performing blockade
measure: Patient satisfaction
timeFrame: for 24 hrs after surgery
measure: Postoperative nausea and vomiting
timeFrame: For 24 hours after surgery
measure: Postoperative headache
timeFrame: For 24 hours after surgery
measure: Hoarseness of voice
timeFrame: For 24 hours after surgery
measure: Dysphagia
timeFrame: For 24 hours after surgery
measure: Respiratory difficulty
timeFrame: For 24 hours after surgery
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Oncolgy Center, Mansoura University,
state: DK
Study officials:
affiliation: Professor of Anesthesia and Surgical Intensive Care
name: Moneir O El-Hefny, MD
role: STUDY_CHAIR
References: