Minimizing Narcotic Analgesics After Endocrine Surgery

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

PHASE4

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-09

Study Completion Date

2020-10-02

Brief Summary

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

This research is being done to better understand and test if the investigators can minimize narcotic medication for controlling pain after thyroid or parathyroid surgery. This research will be performed at Doctors Hospital At Renaissance in the investigators clinic and the perioperative area.

Participants will be randomly chosen to receive one of two options for pain management that the investigators are already using in the care of patients after surgery. One option includes a narcotic medication and one option includes a non-narcotic and a narcotic as needed.

Participants will be asked to complete a form about the level of pain and how much pain medication was needed after surgery in the hospital and while at home. Participants will not have to do any additional visits to participate in this study. The investigators will obtain the research materials at the same time as the usual care visits around the participants' surgery.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pain Medications Following Thyroidectomy and Parathyroidectomy

NCT03640247

Thyroid Disease Parathyroid Diseases

COMPLETED PHASE1

Non-opioid Based Pain Control After Thyroidectomy

NCT03988075

Pain Thyroidectomy

COMPLETED NA

Postoperative Opt-In Narcotic Treatment Study

NCT04710069

Postoperative Pain Narcotic Use Analgesia +3 more

COMPLETED NA

Opioid Use After Thyroid and Parathyroid Surgeries

NCT04955444

Thyroidectomy Parathyroidectomy Opioid Use +1 more

COMPLETED NA

Efficacy of Acetaminophen-ibuprofen Combination on the Postoperative Pain After Thyroidectomy

NCT05626010

Thyroid Disease

UNKNOWN NA

Detailed Description

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

A study team member will give the participant a copy of the informed consent form to read. Participants will have a chance to ask questions about the study before agreeing to participate. If participants agree, they will be randomly chosen to receive one of two options for pain management that the investigators are already using in the care of patients (option 1: Tylenol (also known as acetaminophen) with tramadol if needed, or option 2: Tylenol #3 as needed) after surgery.

Participants will be asked to complete a form about the level of pain and how much pain medication was needed after surgery in the hospital and while at home. Participants will come to the GME General Surgery Center approximately one week after surgery for a post-operative visit so that the investigators can see how much pain medication was used and how much pain the participant had in the first few days after surgery.

Participants will not have to do any additional visits to participate in this study. The investigators will obtain the research materials at the same time as the usual care visits around the participants' surgery. It should take approximately 2 minutes each day to complete.

Conditions

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

Thyroid Cancer Thyroid Nodule Thyroid Neoplasms Thyroid Goitre Thyroid Diseases Parathyroid Diseases Parathyroid Adenoma Parathyroid Hyperplasia

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

option 1: Tylenol (also known as acetaminophen) with tramadol if needed, or option 2: Tylenol #3 as needed

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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

Acetaminophen

Tylenol (also known as acetaminophen) 1000mg every 6 hours for 3 days and tramadol 50 mg every 6 hours as needed for moderate to severe pain

Group Type EXPERIMENTAL

Acetaminophen 500Mg Cap

Intervention Type DRUG

non-narcotic medication first with narcotic as second choice

Tramadol

Intervention Type DRUG

non-narcotic medication first with narcotic as second choice

Codeine Acetaminophen

Tylenol #3 (codeine-acetaminophen) 1 tab every 4 hours or 2 tabs every 6 hours as needed for pain

Group Type ACTIVE_COMPARATOR

Tylenol #3 Oral Tablet

Intervention Type DRUG

Narcotic medication first

Interventions

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

Acetaminophen 500Mg Cap

non-narcotic medication first with narcotic as second choice

Intervention Type DRUG

Tylenol #3 Oral Tablet

Narcotic medication first

Intervention Type DRUG

Tramadol

non-narcotic medication first with narcotic as second choice

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Tylenol codeine-acetaminophen

Eligibility Criteria

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

Inclusion Criteria

1. Adult patients 18 years of age or older,
2. Who are undergoing thyroid or parathyroid surgery at DHR by an Endocrine Surgery faculty member,
3. Provide informed consent to participate in the study in English or Spanish,
4. Patients will be included if they are discharged the same day or on postoperative day 1,
5. Patients who undergo central lymphadenectomy will be included,
6. Patients who undergo two operations within a 2-week period (for example a thyroid lobectomy followed by subsequent completion thyroidectomy) will only have the postoperative narcotic requirements following the initial operation included for the study analysis.
7. Patients who have a complication, such as seroma or hematoma, requiring return to the operating room within 48 hours will be included in the study for the initial operation only.

Exclusion Criteria

1. Patients who undergo lateral neck lymph node dissection will be excluded from the study due to the extent of the operation requiring a different analgesic regimen;
2. Patients allergic to any of the study drugs will be ineligible;
3. Patients who undergo two operations within a 2-week period (for example a thyroid lobectomy followed by subsequent completion thyroidectomy) will only have the initial operation included for the study analysis.
4. Patients with a formal diagnosis of hepatic failure will be ineligible
5. Patients with any diagnosis of chronic pain requiring treatment with ongoing narcotic regimen will be ineligible

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No