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

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ClinicalTrials.gov Identifier: NCT03605914
Recruitment Status : Recruiting
First Posted : July 30, 2018
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Martin J Citardi, MD, The University of Texas Health Science Center, Houston

Study Description
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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
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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

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Arms and Interventions
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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
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03605914


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

Locations
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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
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Principal Investigator: Martin Citardi, MD The University of Texas Health Science Center, Houston
More Information
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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    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Opioid
Hydrocodone
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