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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03269890
Enrollment
74
Registered
2017-09-01
Start date
2017-10-01
Completion date
2018-09-30
Last updated
2020-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Surgery

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.

Interventions

PROCEDURECapsule and cutaneous blocks

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

PROCEDUREUS-intermediate cervical plexus block

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

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Total dose of opioid analgesics usedFor 24 hours after surgeryThe total dose of opioid analgesics required in the post-operative periods

Secondary

MeasureTime frameDescription
Time to first analgesic requestFor 24 hours after surgeryTime to first request for a rescue analgesic
Fentanyl useFor 5 hours after start of anaesthesiaIntraoperative use of fentanyl
Rocuronium useFor 5 hours after start of anaesthesiaIntraoperative use of rocuronium
Sensory blockadefor 1 hour after surgeryAssessment of sensory blockade
Diaphragmatic dysfunctionfor 5 hours after performing blockadeDiaphragmatic dysfunction using ultrasound assessment and possible x ray
Sedation scorefor 5 hours after performing blockadeSedation score using Modified Ramsay scale
Postoperative painFor 24 hours after surgeryPostoperative visual analogue score (VAS) (0 no pain -10 worst imaginable pain),
Postoperative nausea and vomitingFor 24 hours after surgeryfrequency
Postoperative headacheFor 24 hours after surgeryfrequency
Hoarseness of voiceFor 24 hours after surgeryfrequency
DysphagiaFor 24 hours after surgeryfrequency
Respiratory difficultyFor 24 hours after surgeryPeripheral oxygen saturation less than 92%
Patient satisfactionfor 24 hrs after surgeryPatient satisfaction regards analgesia using a score of (0-10) with 10 represents the highest satisfaction

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026