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Completed

NCT Number: NCT03988075

Non-opioid Based Pain Control After Thyroidectomy

Pain control modalities were evaluated after thyroidectomy.

Completed

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Thyroidectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

About this study

Pain control modalities were evaluated after thyroidectomy. Patients were randomized to one of two pain control regimens. The control group received conventional opioid based post operative analgesia while the test group received an enhanced recovery after surgery (ERAS) based anesthesia with use of acetaminophen and non-steroidal anti-inflammatory drugs for the post operative period with opioid medications available for break through pain only. Pain scores (measured on visual analog scale) and opioid use (measured in morphine equivalent dose) were measured after completion of the operation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • thyroid disease

Exclusion criteria

  • currently on opioid pain medications
  • on opioid pain meds in last 30 days
  • cannot take non-opioid medications
  • require more extensive operation than thyroidectomy

Treatment and study plan

Acetaminophen and hydrocodone based pain control

Other

Patients receive acetaminophen 650mg every 4 for pain level 1-3, hydrocodone/acetaminophen 5/325mg every 4 for pain level 4-6, or hydrocodone/acetaminophen 10/650mg every 4 for pain level 7-10 on as needed basis.

Acetaminophen and ibuprofen based pain control

Other

Patients receive standing dose of acetaminophen 650mg every 8 hours and ibuprofen 800mg every 8 hours with alternating ibuprofen and acetaminophen every 4 hours.

Primary outcomes

  1. visual analog scale pain level

    Time frame: 1 hour post operatively

    Pain level from 0 (no pain) to 10 (worst pain imaginable).

  2. visual analog scale pain level

    Time frame: 6 hour post operatively

    Pain level from 0 (no pain) to 10 (worst pain imaginable).

  3. visual analog scale pain level

    Time frame: 24 hour post operatively

    Pain level from 0 (no pain) to 10 (worst pain imaginable).

  4. visual analog scale pain level

    Time frame: 7 days post operatively

    Pain level from 0 (no pain) to 10 (worst pain imaginable).

Secondary outcomes

  1. opioid use

    Time frame: with the first 24 hours post operatively

    the dose of opioid received by the patient

Sponsors and collaborators

Lead sponsor

Medstar Health Research Institute

Other

Registry information

Official study title

Use of Enhanced Recovery After Surgery (ERAS) in Minimizing Opioid Use for Patients Undergoing Thyroidectomy

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 17, 2019
Registry last updated
May 12, 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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