MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
NCT Number: NCT03640247
The purpose of this study is to evaluate the use of a non-narcotic, postoperative pain management regimen on patients undergoing thyroidectomy and parathyroidectomy.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
Cleveland, Ohio, 44109, United States
The purpose of this study is to evaluate the use of a non-narcotic, postoperative pain management regimen for patients undergoing thyroidectomy and parathyroidectomy. The investigators hypothesize that participants receiving non-narcotic pain regimens will have equivalent pain control and satisfaction to those who receive narcotic pain medicines.
The primary objective will be to identify if there is a difference in average perceived postoperative pain scores between participants who do and do not receive narcotic pain medications. Secondary outcomes will include need for breakthrough pain medications, patient satisfaction scores and the need to call the surgeon office for additional pain medications.
The participant will undergo total thyroidectomy, partial thyroidectomy or parathyroidectomy per the standard of care. The study will have no influence on the surgical procedure performed.
Following the surgery, postoperative analgesia regimens will be prescribed based on study randomization.
Narcotic group regimen (63 patients):
Non-narcotic group regimen (63 patients):
Participants will be asked to complete a survey each day for the initial 5 days postoperatively. Survey data includes:
If the participants do not have adequate pain control with the non-narcotic regimen, they may be prescribed additional narcotic pain medication at the discretion of the PI and remain enrolled in the study.
The investigators will also review participants charts for information regarding any postoperative office calls regarding postoperative needs (i.e. for pain medications).
The medical surgical information below is gathered as standard of care for each surgical procedure and will also be collected as part of this procedure:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Non-Narcotic Group. Receives only alternating acetaminophen and ibuprofen
Other names: Ibuprofen 800mg every 8 hours, Acetaminophen 500Mg Tab x2 every 8 hours
Narcotic Group: Alternating acetaminophen and ibuprofen, with a prescription of 10 tablets oxycodone (or if needed based on patient allergies, hydrocodone 5 mg/tramadol 50 mg) for break through pain.
Other names: Ibuprofen 800mg every 8 hours, Oxycodone 5mg every 6 hours prn for pain., Hydrocodone 5 mg every 6 hours prn for pain, Tramadol 50 mg every 6 hours prn for pain, Acetaminophen 500Mg Tab x2 every 8 hours
Time frame: Overall mean pain score from 6 time points (Post operative days 0,1,2,3,4,5)
10 point visual analogue scale- (0- no pain, 1-3 mild, 4-6 moderate pain, 7-10 severe pain).
Time frame: Mean patient satisfaction score from 6 time points (Post operative days 0,1,2,3,4,5)
3 point likert scale (1- easy to manage, 2- manageable but not easy 3- difficult to manage)
Time frame: Mean oral morphine equivalents from 6 time points (Post operative days 0,1,2,3,4,5)
Oral morphine equivalents(OMEQ):
Hydrocodone 5mg =1 OMEQ
Oxycodone 5mg = 1.5 OMEQ
Hydromorphone 1mg = 4 OMEQ
Codeine 5mg = 0.15 OMEQ
Tramadol 5mg = 0.20 OMEQ
Time frame: Mean number of office calls/contacts from 6 time points (Post operative days 0,1,2,3,4,5)
Mean number of office calls/contacts from participants from post operative day 0, 1,2,3,4,5.
MetroHealth Medical Center
Other
Are Narcotic Pain Medications Necessary Following Thyroidectomy and Parathyroidectomy
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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