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OpenTrials
Completed

NCT Number: NCT03269890

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

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.

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Key information

Conditions

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oncolgy Center, Mansoura University,

Al Mansurah, DK, 53316, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Capsule and cutaneous blocks

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

Procedure

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

Primary outcomes

  1. Total dose of opioid analgesics used

    Time frame: For 24 hours after surgery

    The total dose of opioid analgesics required in the post-operative periods

Secondary outcomes

  1. Postoperative pain

    Time frame: For 24 hours after surgery

    Postoperative visual analogue score (VAS) (0 no pain -10 worst imaginable pain),

  2. Time to first analgesic request

    Time frame: For 24 hours after surgery

    Time to first request for a rescue analgesic

  3. Fentanyl use

    Time frame: For 5 hours after start of anaesthesia

    Intraoperative use of fentanyl

  4. Rocuronium use

    Time frame: For 5 hours after start of anaesthesia

    Intraoperative use of rocuronium

  5. Sensory blockade

    Time frame: for 1 hour after surgery

    Assessment of sensory blockade

  6. Diaphragmatic dysfunction

    Time frame: for 5 hours after performing blockade

    Diaphragmatic dysfunction using ultrasound assessment and possible x ray

  7. Sedation score

    Time frame: for 5 hours after performing blockade

    Sedation score using Modified Ramsay scale

  8. Patient satisfaction

    Time frame: for 24 hrs after surgery

    Patient satisfaction regards analgesia using a score of (0-10) with 10 represents the highest satisfaction

  9. Postoperative nausea and vomiting

    Time frame: For 24 hours after surgery

    frequency

  10. Postoperative headache

    Time frame: For 24 hours after surgery

    frequency

  11. Hoarseness of voice

    Time frame: For 24 hours after surgery

    frequency

  12. Dysphagia

    Time frame: For 24 hours after surgery

    frequency

  13. Respiratory difficulty

    Time frame: For 24 hours after surgery

    Peripheral oxygen saturation less than 92%

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 1, 2017
Registry last updated
Sep 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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