Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03469310
Other study ID # 1177315
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date March 9, 2018
Est. completion date October 2, 2020

Study information

Verified date May 2021
Source DHR Health Institute for Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 126
Est. completion date October 2, 2020
Est. primary completion date December 21, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
Acetaminophen 500Mg Cap
non-narcotic medication first with narcotic as second choice
Tylenol #3 Oral Tablet
Narcotic medication first
Tramadol
non-narcotic medication first with narcotic as second choice

Locations

Country Name City State
United States GME General Surgery Clinic Edinburg Texas

Sponsors (1)

Lead Sponsor Collaborator
Minerva A Romero Arenas

Country where clinical trial is conducted

United States, 

References & Publications (6)

Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain - United States, 2016. MMWR Recomm Rep. 2016 Mar 18;65(1):1-49. doi: 10.15585/mmwr.rr6501e1. Erratum in: MMWR Recomm Rep. 2016;65(11):295. — View Citation

Jiang X, Orton M, Feng R, Hossain E, Malhotra NR, Zager EL, Liu R. Chronic Opioid Usage in Surgical Patients in a Large Academic Center. Ann Surg. 2017 Apr;265(4):722-727. doi: 10.1097/SLA.0000000000001780. — View Citation

Rogers SO Jr. Addressing Variability in Opioid Prescribing. JAMA Surg. 2018 Jan 1;153(1):43. doi: 10.1001/jamasurg.2017.3166. — View Citation

Rudd RA, Seth P, David F, Scholl L. Increases in Drug and Opioid-Involved Overdose Deaths - United States, 2010-2015. MMWR Morb Mortal Wkly Rep. 2016 Dec 30;65(50-51):1445-1452. doi: 10.15585/mmwr.mm655051e1. — View Citation

Scully RE, Schoenfeld AJ, Jiang W, Lipsitz S, Chaudhary MA, Learn PA, Koehlmoos T, Haider AH, Nguyen LL. Defining Optimal Length of Opioid Pain Medication Prescription After Common Surgical Procedures. JAMA Surg. 2018 Jan 1;153(1):37-43. doi: 10.1001/jamasurg.2017.3132. — View Citation

Waljee JF, Li L, Brummett CM, Englesbe MJ. Iatrogenic Opioid Dependence in the United States: Are Surgeons the Gatekeepers? Ann Surg. 2017 Apr;265(4):728-730. doi: 10.1097/SLA.0000000000001904. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Staged narcotic analgesic regimen is non-inferior to narcotics in controlling pain 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 Patient will report pain score up to two weeks after surgery
Secondary Is there a difference in the duration of postoperative pain requiring medication The number of days after surgery that participants required pain medications will be counted and assessed for difference between the study arms Patient will report medication requirements up to two weeks after surgery
Secondary Is there a difference in the medication requirement The type and quantity of pain medications used after surgery will be counted and assessed for difference between the study arms Patient will report medication requirements up to two weeks after surgery
Secondary Staged regimen cross over to narcotic The type and quantity of pain medications used after surgery will be counted and number of patients requiring cross over will be assessed Patient will report medication requirements up to two weeks after surgery
See also
  Status Clinical Trial Phase
Recruiting NCT05774535 - Prospective, Observational Study on the Carotid Intima-media Thickness in Patients Undergoing Thyroid Surgery
Withdrawn NCT04224792 - Effects of Exercise Training on Fatigue in Thyroid Cancer Survivors N/A
Completed NCT01728623 - A Study of E7080 in Subjects With Advanced Thyroid Cancer Phase 2
Recruiting NCT03175224 - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Phase 2
Completed NCT02911155 - Cancer and Other Disease Risks in U.S. Nuclear Medicine Technologists
Recruiting NCT05025046 - NGS-based Thyroscan Genomic Classifier in the Diagnosis of Thyroid Nodules
Not yet recruiting NCT03978351 - The Role of Midkine in Diagnosis of Thyroid Cancer
Completed NCT02658513 - Evaluation of Lancet Blood Sampling for Radioiodine Dosimetry in Thyroid Cancer
Terminated NCT02628535 - Safety Study of MGD009 in B7-H3-expressing Tumors Phase 1
Completed NCT02375451 - Effect of Childhood Radioiodine Therapy on Salivary Function N/A
Withdrawn NCT01994200 - Developing and Implementing an Interdisciplinary Team-Based Care Approach (ITCA-ThyCa) for Thyroid Cancer Patients Phase 1/Phase 2
Terminated NCT01403324 - Comparison of Dosimetry After rhTSH or Withdrawal of Thyroid Hormone in Metastatic or Locally Advanced Thyroid Cancer N/A
Completed NCT00970359 - Reacquisition of Radioactive Iodine (RAI) Uptake of RAI-Refractory Metastatic Thyroid Cancers by Pretreatment With the Selective MEK Inhibitor AZD6244 N/A
Completed NCT00439478 - Dental Safety Profile of High-Dose Radioiodine Therapy Phase 4
Completed NCT00223158 - Evaluation Study of L-T3 Utility in the Follow-up of Patients With Thyroid Cancer N/A
Active, not recruiting NCT04544111 - PDR001 Combination Therapy for Radioiodine-Refractory Thyroid Cancer Phase 2
Completed NCT04876287 - Salivary dysfuncTion After Radioiodine Treatment
Recruiting NCT06073223 - Intervention to Decrease Overtreatment of Patients With Low-risk Thyroid Cancer N/A
Recruiting NCT06037174 - Comparison of Quality of Life in Patients With Differentiated Thyroid Carcinoma Undergoing Different Surgery
Recruiting NCT04952493 - Anlotinib or Penpulimab in Combination With RAI for DTC Phase 2