Postoperative Pain and Functional Patient Outcomes After Functional Endoscopic Sinus Surgery

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2010-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Functional Endoscopic Sinus Surgery Study

NCT03970655

Chronic Rhinosinusitis (Diagnosis)

RECRUITING PHASE1/PHASE2

Septorhinoplasty Post-operative Pain Control With SPG Nerve Block

NCT05667324

Deviated Nasal Septum

COMPLETED PHASE4

Post-operative Pain Control With Acetaminophen and Ibuprofen After Functional Endoscopic Sinus Surgery

NCT05287217

Chronic Rhinosinusitis (Diagnosis)

TERMINATED NA

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

NCT03605914

Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty

COMPLETED PHASE4

Clinical Evaluation of the Steroid-Eluting Sinexus Intranasal Splint When Used Following Functional Endoscopic Sinus Surgery (FESS) in Patients With Chronic Sinusitis

NCT00912405

Chronic Sinusitis

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The sphenopalatine ganglion block (SPGB) with local anesthetic is used to treat facial pain and headache of various etiologies and has been widely used during functional endoscopic sinus surgery (FESS). The purpose of this study was to investigate whether preemptive SPGB may positively impact postoperative pain and functional outcomes after FESS.

A prospective, double-blind randomized placebo-controlled study was performed. 60 patients (18 to 70 yrs), undergoing general anesthesia for bilateral FESS, were randomly assigned to receive SPGB with either 2 ml 0.25% bupivacaine with epinephrine 1:100,000 (BP, treatment group) or normal saline (NS, control group). SPGB was performed preemptively 10 min before the start of surgery. Pre- and post operative (day#0, day#7, day#30) visual analogue pain scale, SNOT-20, CT \& Endoscopic scores were compared between the two groups.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain, Postoperative

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1 - Bupivacaine Block

3 ml of 0.25% Bupivacaine with Epi 1:100,000 (A block)

Group Type ACTIVE_COMPARATOR

Bupivacaine Block

Intervention Type DRUG

Bupivacaine local anesthesia block prior to start of FESS procedure.

2 - Placebo

Normal saline with Epi 1:100,000 (B block)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo is identical in appearance in comparison to active drug.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bupivacaine Block

Bupivacaine local anesthesia block prior to start of FESS procedure.

Intervention Type DRUG

Placebo

placebo is identical in appearance in comparison to active drug.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Local Block Placebo saline injection

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No