Non-opioid Based Pain Control After Thyroidectomy

Pain Clinical Trial

Official title:

Use of Enhanced Recovery After Surgery (ERAS) in Minimizing Opioid Use for Patients Undergoing Thyroidectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03988075
• Other study ID #: 2018-022
• Status: Completed
• Phase: N/A
• Start date: July 24, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: May 2020
• Source: Medstar Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pain control modalities were evaluated after thyroidectomy.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 30, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain
• Thyroidectomy

Intervention

Other:
• 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
Patients receive standing dose of acetaminophen 650mg every 8 hours and ibuprofen 800mg every 8 hours with alternating ibuprofen and acetaminophen every 4 hours.

Locations

Country	Name	City	State
United States	MedStar Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Medstar Health Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (4)

Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0 — View Citation

Francis DO, Randolph G, Davies L. Nationwide Variation in Rates of Thyroidectomy Among US Medicare Beneficiaries. JAMA Otolaryngol Head Neck Surg. 2017 Nov 1;143(11):1122-1125. doi: 10.1001/jamaoto.2017.1746. — View Citation

Kehlet H, Wilmore DW. Multimodal strategies to improve surgical outcome. Am J Surg. 2002 Jun;183(6):630-41. Review. — View Citation

Wilmore DW, Kehlet H. Management of patients in fast track surgery. BMJ. 2001 Feb 24;322(7284):473-6. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual analog scale pain level	Pain level from 0 (no pain) to 10 (worst pain imaginable).	1 hour post operatively
Primary	visual analog scale pain level	Pain level from 0 (no pain) to 10 (worst pain imaginable).	6 hour post operatively
Primary	visual analog scale pain level	Pain level from 0 (no pain) to 10 (worst pain imaginable).	24 hour post operatively
Primary	visual analog scale pain level	Pain level from 0 (no pain) to 10 (worst pain imaginable).	7 days post operatively
Secondary	opioid use	the dose of opioid received by the patient	with the first 24 hours post operatively