Non-opioid Based Pain Control After Thyroidectomy

Not Applicable

Completed

• Conditions: Thyroidectomy; Pain
• Interventions: Other: Acetaminophen and hydrocodone based pain control; Other: Acetaminophen and ibuprofen based pain control

• Registration Number: NCT03988075
• Lead Sponsor: Medstar Health Research Institute

Brief Summary

Pain control modalities were evaluated after thyroidectomy.

Detailed Description

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.

Study Timeline

• Study Start: 2018-07-24
• Study First Submitted: 2019-05-14
• Study First Submitted QC: 2019-06-14
• Study First Posted: 2019-06-17
• Primary Completion: 2019-08-01
• Study Completion: 2019-09-30
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-08
• Last Update Posted: 2020-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acetaminophen and hydrocodone based pain control	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.
Acetaminophen and ibuprofen based pain control	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.

Primary Outcome Measures

Name	Time	Method
visual analog scale pain level	7 days post operatively	Pain level from 0 (no pain) to 10 (worst pain imaginable).

Secondary Outcome Measures

Name	Time	Method
opioid use	with the first 24 hours post operatively	the dose of opioid received by the patient

Trial Locations

Locations (1)

MedStar Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States