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

Primary Purpose

Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

diclofenac

Norco

About this trial

This is an interventional treatment trial for Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NSAID

opioid

Arm Description

The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac.

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

Number of Participants With Bleeding Complications

Bleeding complications are defined as complications necessitating a trip to the emergency room or requiring intervention for epistaxis.

Number of Participants With Constipation

Number of Participants With Nausea or Vomiting

Full Information

NCT ID

NCT03605914

First Posted

July 4, 2018

Last Updated

July 16, 2021

Sponsor

The University of Texas Health Science Center, Houston

1. Study Identification

Unique Protocol Identification Number

NCT03605914

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

August 1, 2018 (Actual)

Primary Completion Date

July 1, 2020 (Actual)

Study Completion Date

July 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NSAID

Arm Type

Experimental

Arm Description

The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac.

Arm Title

opioid

Arm Type

Active Comparator

Arm Description

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).

Intervention Type

Drug

Intervention Name(s)

diclofenac

Intervention Description

The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac.

Intervention Type

Drug

Intervention Name(s)

Norco

Other Intervention Name(s)

Hydrocodone-Acetaminophen combination medication

Intervention Description

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).

Primary Outcome Measure Information:

Title

Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)

Description

The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain.

Time Frame

24 hours (day 1 after operation)

Secondary Outcome Measure Information:

Title

Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)

Description

The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain.

Time Frame

48 hours (day 2 after operation)

Title

Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)

Description

The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain.

Time Frame

72 hours (day 3 after operation)

Title

Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)

Description

The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain.

Time Frame

120 hours (day 5 after operation)

Title

Number of Participants With Bleeding Complications

Description

Bleeding complications are defined as complications necessitating a trip to the emergency room or requiring intervention for epistaxis.

Time Frame

5 days after operation

Title

Number of Participants With Constipation

Time Frame

5 days after operation

Title

Number of Participants With Nausea or Vomiting

Time Frame

5 days after operation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martin Citardi, MD

Organizational Affiliation

The University of Texas Health Science Center, Houston

Official's Role

Principal Investigator

Facility Information:

Facility Name

The University of Texas Health Science Center at Houston

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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