Non-opioid Based Pain Control After Thyroidectomy

NCT ID: NCT03988075

Last Updated: 2020-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-24

Study Completion Date

2019-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Pain control modalities were evaluated after thyroidectomy.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain Thyroidectomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized to one of two study groups
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Acetaminophen and hydrocodone based pain control

Intervention Type 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

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

Group Type EXPERIMENTAL

Acetaminophen and ibuprofen based pain control

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medstar Health Research Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Erin Felger, MD

Role: PRINCIPAL_INVESTIGATOR

Medstar Health Research Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

MedStar Washington Hospital Center

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

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 29049468 (View on PubMed)

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.

Reference Type RESULT
PMID: 28403427 (View on PubMed)

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.

Reference Type RESULT
PMID: 11222424 (View on PubMed)

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.

Reference Type RESULT
PMID: 12095591 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2018-022

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

T3AI-Pain After Breast Surgery
NCT00299039 COMPLETED PHASE3
Post-tonsillectomy Pain Control in Adults
NCT02358850 TERMINATED PHASE4