Non-opioid Based Pain Control After Thyroidectomy

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

Pain control modalities were evaluated after thyroidectomy.

Study Overview

• Status: Completed
• Conditions: Pain; Thyroidectomy
• Intervention / Treatment: Other: Acetaminophen and hydrocodone based pain control; Other: Acetaminophen and ibuprofen based pain control

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar Washington Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Acetaminophen and hydrocodone based pain control; 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.	Other: Acetaminophen and hydrocodone based pain control; 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.
Experimental: Acetaminophen and ibuprofen based pain control; Patients receive standing dose of acetaminophen 650mg every 8 hours and ibuprofen 800mg every 8 hours with alternating ibuprofen and acetaminophen every 4 hours.	Other: Acetaminophen and ibuprofen based pain control; Patients receive standing dose of acetaminophen 650mg every 8 hours and ibuprofen 800mg every 8 hours with alternating ibuprofen and acetaminophen every 4 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analog scale pain level	Pain level from 0 (no pain) to 10 (worst pain imaginable).	1 hour post operatively
visual analog scale pain level	Pain level from 0 (no pain) to 10 (worst pain imaginable).	6 hour post operatively
visual analog scale pain level	Pain level from 0 (no pain) to 10 (worst pain imaginable).	24 hour post operatively
visual analog scale pain level	Pain level from 0 (no pain) to 10 (worst pain imaginable).	7 days post operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
opioid use	the dose of opioid received by the patient	with the first 24 hours post operatively

Collaborators and Investigators

• Sponsor: Medstar Health Research Institute
• Investigators: Principal Investigator: Erin Felger, MD, MedStar Health Research Institute

Publications and helpful links

General Publications

• Francis DO, Randolph G, Davies L. Nationwide Variation in Rates of Thyroidectomy Among US Medicare Beneficiaries. JAMA Otolaryngol Head Neck Surg. 2017 Nov 1;143(11):1122-1125. doi: 10.1001/jamaoto.2017.1746.
• Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21. Erratum In: JAMA Surg. 2019 Mar 1;154(3):272.
• Wilmore DW, Kehlet H. Management of patients in fast track surgery. BMJ. 2001 Feb 24;322(7284):473-6. doi: 10.1136/bmj.322.7284.473. No abstract available.
• Kehlet H, Wilmore DW. Multimodal strategies to improve surgical outcome. Am J Surg. 2002 Jun;183(6):630-41. doi: 10.1016/s0002-9610(02)00866-8.

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2018
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: May 14, 2019
• First Submitted That Met QC Criteria: June 14, 2019
• First Posted (Actual): June 17, 2019

Study Record Updates

• Last Update Posted (Actual): May 12, 2020
• Last Update Submitted That Met QC Criteria: May 8, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Analgesics, Opioid; Narcotics; Respiratory System Agents; Antitussive Agents; Acetaminophen; Ibuprofen; Hydrocodone
• Other Study ID Numbers: 2018-022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No