Effect of Post-operative Ibuprofen After Surgery for Chronic Rhinosinusitis

NCT ID: NCT03055507

Last Updated: 2023-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2017-12-31

Brief Summary

Endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS) is a common procedure in the US, with about 250,000 cases performed annually. Currently, there is no consensus, evidence-based post-operative pain regimen; with the majority of practitioners opting for a combination of acetaminophen and narcotics for pain control. Most rhinologists avoid NSAIDs due to decreased platelet aggregation and the theoretical risk of increased post-operative bleeding. No studies to date have evaluated the use of ibuprofen in CRS patients following ESS. Additionally, there is a lack of information regarding the average narcotic requirement following ESS.

The purpose of this pilot prospective cohort study is to evaluate the use of narcotics in sinus surgery and the effect of ibuprofen in the non-packed nose following ESS. This investigation will help to gain understanding of current opioid use in post-op sinus patients and assess the safety and effectiveness of post-operative ibuprofen administration on pain. The investigators aim to quantify the average narcotic use following ESS, as well as evaluate the effect of the addition of ibuprofen to the standard analgesic regimen on pain scores and post-operative epistaxis. The investigators hypothesize that the use of ibuprofen will decrease pain scores on a 10-cm visual analogue scale when compared with individuals who do not use ibuprofen post-operatively, this will lead to decreased opioid use in the post-operative period. Additionally, the investigators hypothesize no increase in post-operative bleeding rates, again based on a 10-cm visual analogue scale and bleeding events.

In summary, this will be the first study to the investigators knowledge to examine the effect of post-operative ibuprofen use and its effects on opioid use, as well as pain and epistaxis outcomes, in ESS. By performing this pilot prospective cohort study, the investigators will be equipped to design and perform the optimal prospective, randomized study evaluating the effect of NSAID in ESS during the post-operative period. The overarching goal of this investigation is to decrease opioid use in post-operative pain control following ESS.

Detailed Description

Opioid use and abuse is a major public health issue. US Surgeon General, Dr. Vikta Murthy, has recently called for investigation into evidence-based prescribing of opioids. Endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS) is a common procedure in the US, with about 250,000 cases performed annually.1 Currently, there is no consensus for appropriate post-operative analgesic control after ESS. Many practitioners use a combination of acetaminophen and narcotics for pain control. Importantly, most rhinologists avoid the use of NSAIDs due to a theoretical concern for decreased platelet aggregation and the potential risk of increased post-operative hemorrhage. However, no studies to date have evaluated the use of ibuprofen in CRS patients following ESS. Conceivably, if the investigators can improve post-operative pain control after ESS with using ibuprofen, then that may decrease standard prescriptions for narcotic analgesics. Given that 60% of narcotic overdose deaths are due to prescribed medications, this would help deliver improved pain control with less narcotic prescriptions. Therefore, the objective is to perform a pilot prospective cohort study to evaluate the use of narcotics in sinus surgery and the effect of ibuprofen following ESS. This pilot study will provide critical baseline data for narcotic use, ibuprofen safety and ibuprofen analgesic impact to optimize the design of a future prospective, randomized study. Thus, specific aims are as follows:

Specific Aim 1: Patients with CRS will document their narcotic use in the first 7 days following sinus surgery. This will allow us to reform prescribing practices. Hypothesis: There will be a wide range of narcotic usage among post-op patients with the mean usage being less than the amount typically prescribed post-operatively.

Specific Aim 2: During enrollment the investigators will ask patients to self-select the study arm they would like to join (ibuprofen versus no ibuprofen) thus documenting willingness to participate, which is important in designing the future randomized study. Hypothesis: Most patients approached will be wiling to participate and will indicate willingness to be part of a similar randomized study.

Specific Aim 3a: Determine impact of ibuprofen on post-operative sinus surgery patients' pain level. The investigators will analyze patients with CRS that are set to undergo ESS in two cohorts (standard pain regimen and standard pain regimen plus ibuprofen) and assess postoperative pain at days 1, 3, and 7 by 10-cm visual analogue scale, amount of post-operative narcotic pain medication used, and number of days post-operatively taking narcotic medications, Hypothesis: Addition of ibuprofen will decrease post-operative pain and will decrease number of opioid pills used.

Specific Aim 3b: Determine impact of ibuprofens impact on post-operative epistaxis. Using the same patient cohorts, degree of epistaxis will be assessed utilizing standardized recording documents and a 10-cm visual analogue scale, as well as a previously used epistaxis grading system.2 The investigators will assess these outcomes on post-operative day 1, 3, and 7. Hypothesis: Addition of ibuprofen will demonstrate no increase in post-operative epistaxis compared to the control group.

At the study institution, approximately 250 endoscopic sinus cases are performed per year performed by two rhinologists. This will yield ample potential research subjects to complete the study. To the investigators knowledge, there is one previous study looking at the effect of peri-operative NSAIDs during ESS. This study found no increased risk in intraoperative or postoperative bleeding after administration of ketorolac. This will be the first study to examine the effect of post-operative oral ibuprofen use and its effects on opioid use, as well as pain and epistaxis outcomes.

Conditions

Chronic Rhinosinusitis (Diagnosis)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

Standard pain regimen of acetaminophen 650 mg q6hrs while awake until cessation of need for scheduled pain medication with the addition of oxycodone 5 mg q3 hrs PRN (as needed) pain.

Group Type: ACTIVE_COMPARATOR

Acetaminophen 650 mg

Intervention Type: DRUG

Standard analgesic provided post-operatively to patients undergoing sinus surgery

OxyCODONE 5 Mg Oral Tablet

Intervention Type: DRUG

Standard PRN medication offered post-operatively for breakthrough pain

Ibuprofen

Alternating every 3 hours acetaminophen 650 mg and ibuprofen 400 mg while awake until cessation of need for schedule pain medication with the addition of oxycodone 5 mg q3hr PRN pain.

Group Type: EXPERIMENTAL

Ibuprofen 400 mg

Intervention Type: DRUG

Addition of ibuprofen to standard pain regimen.

Acetaminophen 650 mg

Intervention Type: DRUG

Standard analgesic provided post-operatively to patients undergoing sinus surgery

OxyCODONE 5 Mg Oral Tablet

Intervention Type: DRUG

Standard PRN medication offered post-operatively for breakthrough pain

Interventions

Ibuprofen 400 mg

Addition of ibuprofen to standard pain regimen.

Intervention Type: DRUG

Acetaminophen 650 mg

Standard analgesic provided post-operatively to patients undergoing sinus surgery

Intervention Type: DRUG

OxyCODONE 5 Mg Oral Tablet

Standard PRN medication offered post-operatively for breakthrough pain

Intervention Type: DRUG

Other Intervention Names

Motrin; Tylenol; Paracetamol

Eligibility Criteria

Inclusion Criteria

• Patients with CRS scheduled to undergo functional endoscopic sinus surgery
• >18 years old
• Able to speak and comprehend written English

Exclusion Criteria

• Contraindication to NSAID use (Chronic kidney disease, Peptic Ulcer disease, Aspirin exacerbated respiratory disorder (AERD), etc.)
• Previous history of bleeding disorder
• Sinus cancer
• Cystic Fibrosis
• Current use of anti-coagulant or anti-platelet medication (during and immediately after ESS)
• History of chronic pain, fibromyalgia, or opioid addiction
• Excessive bleeding during the surgery as determined by the attending surgeon
• Contraindication to acetaminophen use
• Daily use of analgesics including ibuprofen, other NSAIDs, acetaminophen, narcotic medications or other analgesics.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Craig Miller

Resident, School of Medicine: Otolaryngology-Head & Neck Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Craig Miller, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington Medical Center

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

STUDY00000798

Identifier Type: -

Identifier Source: org_study_id