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

• Sponsor: The University of Texas Health Science Center, Houston
• Information provided by (Responsible Party): Martin J Citardi, MD, The University of Texas Health Science Center, Houston

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty	Drug: diclofenac; Drug: Norco	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Are NSAIDs Effective Enough for Postoperative Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty
• Actual Study Start Date: August 1, 2018
• Estimated Primary Completion Date: April 2019
• Estimated Study Completion Date: July 2019

Arms and Interventions

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 Name: Hydrocodone-Acetaminophen combination medication

Outcome Measures

Primary Outcome Measures :

1. Pain score as assessed by a 100mm visual analogue scale (VAS) [ Time Frame: 24 hours ]
   The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain.

Secondary Outcome Measures :

1. Pain score as assessed by a 100mm visual analogue scale (VAS) [ Time Frame: 48 hours ]
   The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain.
2. Pain score as assessed by a 100mm visual analogue scale (VAS) [ Time Frame: 72 hours ]
   The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain.
3. Pain score as assessed by a 100mm visual analogue scale (VAS) [ Time Frame: 120 hours ]
   The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain.
4. Number of participants with bleeding complications [ Time Frame: 5 days after operation ]
   Bleeding complications are defined as complications necessitating a trip to the emergency room or requiring intervention for epistaxis.
5. Number of participants with constipation [ Time Frame: 5 days after operation ]
6. Number of participants with nausea or vomiting [ Time Frame: 5 days after operation ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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)

Contacts and Locations

Contacts

Contact: Martin J Citardi, MD; (713) 500-5410; Martin.J.Citardi@uth.tmc.edu

Locations

United States, Texas

The University of Texas Health Science Center at Houston; Recruiting

Houston, Texas, United States, 77030

Contact: Martin J Citardi, MD 713-500-5410 Martin.J.Citardi@uth.tmc.edu

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

Investigators

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

More Information

• Responsible Party: Martin J Citardi, MD, Professor and Chairman, Department of Otorhinolaryngology - Head and Neck Surgery, The University of Texas Health Science Center, Houston
• ClinicalTrials.gov Identifier: NCT03605914 History of Changes
• Other Study ID Numbers: HSC-MS-18-0242
• First Posted: July 30, 2018
• Last Update Posted: October 15, 2018
• Last Verified: October 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms; Analgesics, Opioid; Hydrocodone; Acetaminophen, hydrocodone drug combination; Acetaminophen; Diclofenac; Anti-Inflammatory Agents, Non-Steroidal; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Analgesics, Non-Narcotic; Antipyretics; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antitussive Agents; Respiratory System Agents