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

• ClinicalTrials.gov Identifier: NCT03605914
• Recruitment Status: Completed
• First Posted: July 30, 2018
• Last Update Posted: November 2, 2020
• 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)
• Actual 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
• Actual Primary Completion Date: July 1, 2020
• Actual Study Completion Date: July 5, 2020

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

Locations

United States, Texas

The University of Texas Health Science Center at Houston

Houston, Texas, United States, 77030

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
• Other Study ID Numbers: HSC-MS-18-0242
• First Posted: July 30, 2018
• Last Update Posted: November 2, 2020
• Last Verified: October 2020

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; Acetaminophen; Diclofenac; Hydrocodone; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Antipyretics; Anti-Inflammatory Agents, Non-Steroidal; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Antitussive Agents; Respiratory System Agents