Minimizing Narcotic Analgesics After Endocrine Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03469310|
Recruitment Status : Completed
First Posted : March 19, 2018
Last Update Posted : May 11, 2021
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
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.
|Condition or disease||Intervention/treatment||Phase|
|Thyroid Cancer Thyroid Nodule Thyroid Neoplasms Thyroid Goitre Thyroid Diseases Parathyroid Diseases Parathyroid Adenoma Parathyroid Hyperplasia||Drug: Acetaminophen 500Mg Cap Drug: Tylenol #3 Oral Tablet Drug: Tramadol||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||126 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||option 1: Tylenol (also known as acetaminophen) with tramadol if needed, or option 2: Tylenol #3 as needed|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Minimizing Narcotic Analgesics After Thyroid or Parathyroid Surgery|
|Actual Study Start Date :||March 9, 2018|
|Actual Primary Completion Date :||December 21, 2019|
|Actual Study Completion Date :||October 2, 2020|
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
Drug: Acetaminophen 500Mg Cap
non-narcotic medication first with narcotic as second choice
Other Name: Tylenol
non-narcotic medication first with narcotic as second choice
Active Comparator: Codeine Acetaminophen
Tylenol #3 (codeine-acetaminophen) 1 tab every 4 hours or 2 tabs every 6 hours as needed for pain
Drug: Tylenol #3 Oral Tablet
Narcotic medication first
Other Name: codeine-acetaminophen
- Staged narcotic analgesic regimen is non-inferior to narcotics in controlling pain [ Time Frame: Patient will report pain score up to two weeks after surgery ]Patient pain scores will be logged using Wong-Baker FACES pain rating scale (range 0-10) and scores will be assessed for differences between the study arms
- Is there a difference in the duration of postoperative pain requiring medication [ Time Frame: Patient will report medication requirements up to two weeks after surgery ]The number of days after surgery that participants required pain medications will be counted and assessed for difference between the study arms
- Is there a difference in the medication requirement [ Time Frame: Patient will report medication requirements up to two weeks after surgery ]The type and quantity of pain medications used after surgery will be counted and assessed for difference between the study arms
- Staged regimen cross over to narcotic [ Time Frame: Patient will report medication requirements up to two weeks after surgery ]The type and quantity of pain medications used after surgery will be counted and number of patients requiring cross over will be assessed
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Adult patients 18 years of age or older,
- Who are undergoing thyroid or parathyroid surgery at DHR by an Endocrine Surgery faculty member,
- Provide informed consent to participate in the study in English or Spanish,
- Patients will be included if they are discharged the same day or on postoperative day 1,
- Patients who undergo central lymphadenectomy will be included,
- 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.
- 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.
- 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;
- Patients allergic to any of the study drugs will be ineligible;
- 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.
- Patients with a formal diagnosis of hepatic failure will be ineligible
- Patients with any diagnosis of chronic pain requiring treatment with ongoing narcotic regimen will be ineligible
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03469310
|United States, Texas|
|GME General Surgery Clinic|
|Edinburg, Texas, United States, 78539|
|Principal Investigator:||Minerva A Romero Arenas, MD, MPH||GME General Surgery|
|Principal Investigator:||Samuel K Snyder, MD||GME General Surgery|
|Principal Investigator:||Henry A Reinhart, MD||GME General Surgery|
|Responsible Party:||Minerva A Romero Arenas, Principal Investigator, DHR Health Institute for Research and Development|
|Other Study ID Numbers:||
|First Posted:||March 19, 2018 Key Record Dates|
|Last Update Posted:||May 11, 2021|
|Last Verified:||May 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||De-identified information only will be made available to interested researchers.|
Informed Consent Form (ICF)
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Respiratory System Agents