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NCT Number: NCT02205801

Study of the Efficacy of Local Analgesia as an Adjunct to General Anesthesia in Thyroidectomy and Parathyroidectomy

We aim to study the effect of local anesthetic when used in conjunction with general anesthesia during thyroidectomy or parathyroidectomy. We hypothesize there is equivalent pain control between bilateral superficial cervical plexus block and local wound infiltration when used in conjunction with a general anesthetic.

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Key information

Conditions

Thyroid Neoplasms Autoimmune Diseases Endocrine Gland Neoplasms Endocrine System Diseases Exophthalmos Eye Diseases Goiter Goiter, Nodular Graves Disease Graves' Disease Head and Neck Neoplasms Hyperparathyroidism Hyperthyroidism Immune System Diseases Neoplasms Neoplasms by Site Orbital Diseases Parathyroid Diseases Thyroid Diseases Thyroid Nodule

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient ≥ 18 years old
  • Surgical indication for parathyroidectomy or thyroidectomy

Exclusion criteria

  • Patients < 18 years old
  • Patient with history of chronic opioid use
  • Patient with chronic pain syndromes
  • Patient with allergy to marcaine

Treatment and study plan

Superficial Cervical Plexus Block

Procedure

0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.

Local wound infiltration

Procedure

0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.

0.9% saline

Drug

marcaine

Drug

Primary outcomes

  1. Intraoperative Fentanyl Administration

    Time frame: During the procedure

    The total amount of Fentanyl administered during the procedure will be recorded.

Secondary outcomes

  1. Post Operative Pain

    Time frame: At four hour after operation

    Pain scores will either be verbally reported to nursing and recorded or reported on a questionnaire. Back of neck pain scores range 0-10, throat pain scores range 0-9, incisional pain scores range 0-9 (zero means no pain and 9 or 10 means severe pain).

  2. Post Operative Nausea Score

    Time frame: At 2 weeks after operation

    Nausea scores will either be verbally reported to nursing and recorded or reported on a questionnaire. The scores range 0-9 (zero means no symptom and 9 means "very severe").

  3. Total Pain Medication Utilization

    Time frame: At follow up appointment 1-2 weeks postoperatively

    Total operative opioid dosages administered converted to effective mg of Hydromorphine.

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

A Randomized Control Trial Comparing Bilateral Superficial Cervical Plexus Block and Local Wound Infiltration in Thyroidectomy and Parathyroidectomy

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jul 31, 2014
Registry last updated
Mar 9, 2018

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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