Celecoxib vs. Acetaminophen/Codeine/Caffeine for Post-operative Analgesia in Rhinoplasty.

Pain, Postoperative Clinical Trial

Official title:

Celecoxib vs. Acetaminophen-codeine-caffeine for Postoperative Pain in Primary Elective Open Septorhinoplasty With Osteotomies: a Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04259333
• Other study ID #: 16511
• Status: Recruiting
• Phase: Phase 4
• Start date: March 1, 2020
• Est. completion date: December 1, 2020

Study information

• Verified date: August 2020
• Source: Humber River Hospital
• Contact: Blake S Raggio, MD
• Phone: 504-235-3994
• Email: blakeraggio[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary aim of this study is to evaluate whether celecoxib (CELEBREX) is equivalent to acetaminophen-codeine-caffeine (TYLENOL# 3) for the management of pain after primary elective open septorhinoplasty with osteotomies.

Secondary objectives include comparison of adverse medication effects and complications (e.g., bleeding events and bruising) that occur postoperatively.

Half of the study participants will receive celecoxib, and half will receive acetaminophen-codeine-caffeine.

We hypothesize that both interventions will exhibit no difference in pain control or postoperative bleeding, but that participants taking CELEBREX will experience less medication-related side effects and less bruising postoperatively.

Description:

The recent recognition of the opioid crisis has prompted a nationwide search for alternative postoperative analgesia regimens, especially in the field of plastic and reconstructive surgery where patients exhibit a significant risk of persistent opioid use afterward.

As such, the contemporary facial plastics literature has noticed a surge in publications that implement various multi-modal analgesia (MMA) regimens to mitigate narcotic use postoperatively, the results of which seem promising.

Among the opioid-sparing medications utilized in MMA regimens, the selective COX-2 inhibitors (e.g., celecoxib, parecoxib) are of interest given their similar analgesic efficacy and decreased risk profile (less nausea, constipation, and dependence) compared to opioids. Furthermore, selective COX-2 inhibitors avoid adverse gastrointestinal and renal events, as well as the antiplatelet effects associated with conventional NSAIDs (e.g., ibuprofen and naproxen). For these reasons, selective COX-2 inhibitors make for the ideal analgesic to use after facial plastic surgery procedures, where increased bleeding can delay wound healing (e.g., increased bruising and swelling) and cause potentially devastating complications (e.g., hematoma after a facelift, or epistaxis after septorhinoplasty). Nonetheless, studies evaluating the role of selective COX-2 inhibitors as safe and effective alternatives to opioids in plastic surgery are scant.

The primary aim of this study is to evaluate whether celecoxib is equivalent to a routinely prescribed analgesia, acetaminophen-codeine-caffeine (trade name TYLENOL#3) for the management of pain after primary cosmetic open septorhinoplasty with osteotomies. Secondary objectives include comparison of adverse effects that occur post-operatively, with attention to medication side effects, as well as bleeding events and bruising.

We hypothesize that both interventions will exhibit no difference in pain control or postoperative bleeding or bruising, but that participants taking acetaminophen/codeine will experience more adverse effects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• • Patients 18-80 years old undergoing elective primary open septorhinoplasty with osteotomies by single surgeon, JA.

Exclusion Criteria:

• • Patients who undergo a rhinoplasty requiring a rib, ear, or temporalis fascia graft (confounding variables for the level of pain experienced)

• Patients with a known history of chronic pain disorder, or who have gastrointestinal bleeds, peptic ulcer disease or who have other comorbidities that may prevent them from taking NSAIDs such as CELEBREX.

• Patients with a history of radiation, active head and neck malignancy or other chronic pain disorders such as various rheumatologic diseases will be excluded to decrease confounding factors in assessing pain.

Related Conditions & MeSH terms

• Opioid Analgesic Adverse Reaction
• Opioid Use
• Pain, Postoperative
• Surgery--Complications

Intervention

Drug:
• Celecoxib 200mg
Celecoxib tablet
• Acetaminophen, Codeine Drug Combination
acetaminophen-codeine-caffeine tablet

Locations

Country	Name	City	State
Canada	FACE Toronto	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Blake Raggio	University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Severity	Difference in daily mean pain intensity based on Numeric Rating Scale (NRS). The NRS is composed of 0 (no pain at all) to 10 (worst imaginable pain).	until the time of cast removal (up to 8 days postoperatively)
Secondary	Medication-related side effects	patient self-reported questionnaire	for side effects experienced up to the day of cast removal (up to 8 days postoperatively)
Secondary	Complications postoperatively	patient self-reported questionnaire	for complications experienced up to the day of cast removal (up to 8 days postoperatively)
Secondary	Bruising	blinded outcome assessor will rank bruising severity based on Numeric Rating Scale (NRS), using postoperative photographs taken on day of cast removal. The NRS is composed of 0 (no brusing at all) to 10 (worst imaginable bruising).	day 6-8. depending on day of cast removal