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

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.

Study Overview

• Status: Completed
• Conditions: Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty
• Intervention / Treatment: Drug: diclofenac; Drug: Norco

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: NSAID; The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac.	Drug: diclofenac; The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac.
ACTIVE_COMPARATOR: opioid; 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).	Drug: 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).; Other Names: Hydrocodone-Acetaminophen combination medication

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)	The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain.	48 hours (day 2 after operation)
Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)	The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain.	72 hours (day 3 after operation)
Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)	The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain.	120 hours (day 5 after operation)
Number of Participants With Bleeding Complications	Bleeding complications are defined as complications necessitating a trip to the emergency room or requiring intervention for epistaxis.	5 days after operation
Number of Participants With Constipation		5 days after operation
Number of Participants With Nausea or Vomiting		5 days after operation

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Martin Citardi, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2018
• Primary Completion (ACTUAL): July 1, 2020
• Study Completion (ACTUAL): July 5, 2020

Study Registration Dates

• First Submitted: July 4, 2018
• First Submitted That Met QC Criteria: July 26, 2018
• First Posted (ACTUAL): July 30, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 20, 2021
• Last Update Submitted That Met QC Criteria: July 16, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Analgesics, Opioid; Narcotics; Respiratory System Agents; Antitussive Agents; Acetaminophen; Diclofenac; Hydrocodone
• Other Study ID Numbers: HSC-MS-18-0242

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No