Are NSAIDs Effective Enough for Postoperative Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty

Phase 4

Completed

• Conditions: Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty
• Interventions: Drug: Norco; Drug: diclofenac

• Registration Number: NCT03605914
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

The purpose of this study is to compare the level of pain control in patients receiving non-steroidal anti-inflammatory drugs (NSAIDs) to those receiving opioids in the postoperative period after endoscopic sinus surgery (ESS) and/or septoplasty.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-04
• Study First Submitted QC: 2018-07-26
• Study First Posted: 2018-07-30
• Study Start: 2018-08-01
• Primary Completion: 2020-07-01
• Study Completion: 2020-07-05
• Results First Submitted: 2021-06-27
• Status Verified: 2021-07
• Results First Submitted QC: 2021-07-16
• Last Update Submitted: 2021-07-16
• Results First Posted: 2021-07-20
• Last Update Posted: 2021-07-20

Recruitment & Eligibility

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

Inclusion Criteria

• english speaking
• candidates for endoscopic sinus surgery as determined by medical necessity by the treating rhinologist
• scheduled for surgery at Texas Sinus Institute

Exclusion Criteria

• allergy to either NSAIDs or opioids
• contraindication to NSAIDs (ex. gastritis, chronic kidney disease)
• surgical plan exceeding basic endoscopic sinus surgery
• use of anticoagulation
• the presence of any pain disorder
• the current usage of any analgesic medication
• history of opioid addiction
• pregnancy
• history of chronic pain or fibromyalgia
• current daily use of NSAIDs, acetaminophen, opioids or other analgesics (pregabalin, tramadol, etc)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
opioid	Norco	The Opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen).
NSAID	diclofenac	The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac.

Primary Outcome Measures

Name	Time	Method
Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)	24 hours (day 1 after operation)	The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Constipation	5 days after operation
Number of Participants With Nausea or Vomiting	5 days after operation
Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)	120 hours (day 5 after operation)	The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain.
Number of Participants With Bleeding Complications	5 days after operation	Bleeding complications are defined as complications necessitating a trip to the emergency room or requiring intervention for epistaxis.

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States