Phase 4 N=56 Randomized Quadruple-blind Treatment

Postoperative Pain and Functional Patient Outcomes After Functional Endoscopic Sinus Surgery

Pain, Postoperative

Bottom Line

View on ClinicalTrials.gov: NCT00927888 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2015

Primary outcome: Primary: Postoperative Pain Assessed on Standard VAS Scale — 0.48; 1.12 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Bupivacaine Block (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Stanford University
Primary completion: Mar 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Postoperative Pain Assessed on Standard VAS Scale	0.48; 1.12	—
SECONDARY SNOT-20 Surgical Outcome Score	1.76; 1.67	—

Summary

The aim of the study is to quantify postoperative pain after functional endoscopic sinus surgery (FESS) and investigate whether preemptive analgesia may positively impact intraoperative anesthetic management, decrease patient postoperative pain and discomfort, and improve patient functional outcomes.

Eligibility Criteria

Inclusion Criteria

The study subjects will be 18-70 year old.
The subjects will be American Society of Anesthesiology physical status I and II patients.
Patients with chronic rhinosinusitis, presenting for bilateral functional endoscopic sinus surgery.
The subjects should understand informed consent and study instructions, AND 5. The subjects should not participate in any other research protocols.

Exclusion Criteria

Patients with pre-existing chronic facial pain not related to chronic rhinosinusitis.
Patients with pre-existing chronic pain of different etiology.
Patients taking prescription pain medications.
Patients taking antidepressant medications.
Patients taking over-the-counter pain medications within 48 hours of scheduled surgery.
Patients in whom oral opioid-containing analgesics would be contraindicated postoperatively.
Patients with a known or suspected genetic susceptibility to malignant hyperthermia, or known sensitivity to Desflurane or other halogenated agents.
Patients with the history of arrhythmias or significant coronary artery disease.
Patients with psychological disorders.
Patients who are unable to understand the questionnaires or the visual analogue scale (VAS) pain scores.
Patients with the history of substance or alcohol abuse.
Patients with compromised renal and liver function.
Patients with abnormal coagulation status or platelet count less than 100,000.
Pregnant patients.
Patients with an allergy to Bupivacaine, Lidocaine or Epinephrine.
Other patients that may be excluded by the investigator, based on medical history and physical examination

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00927888). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.