Postoperative Pain and Functional Patient Outcomes After Functional Endoscopic Sinus Surgery
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Effect of Preemptive Sphenopalatine Ganglion Block on Anesthetic Requirements, Postoperative Pain and Functional Patient Outcomes After Functional Endoscopic Sinus Surgery|
- Postoperative Pain Assessed on Standard VAS Scale [ Time Frame: VAS Pain Score at 7 days ] [ Designated as safety issue: No ]Post-operative quality of recovery and pain followed up to 1 month. Visual Analog Pain (VAS) was recorded by the patient on a 10-centimeter line to mark an estimated pain score that could be from zero (0) to ten (10). Zero would indicate no pain while a score of 10 would be the worse pain possible.
- SNOT-20 Surgical Outcome Score [ Time Frame: 1-day ] [ Designated as safety issue: No ]
This measures uses a 20 item surgical assessment tool to assess surgical field. This assessment score is the Sino-Nasal Outcome Test, SNOT-20. Patients were completed this validated sinus symptom questionnaire. The average magnitude score for the 20 items is calculated. Each item of the 20-question assessment is scored from 1 to 5 where 1 is less severe and 5 is a maximum as described by that particular symptom score. The final score is reported as a mean with a range of 0 (zero) to 5 (no units).
ref. Otolaryngol Head Neck Surg, 126 (2002), pp. 41-47
|Study Start Date:||August 2007|
|Study Completion Date:||August 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Active Comparator: 1 - Bupivacaine Block
3 ml of 0.25% Bupivacaine with Epi 1:100,000 (A block)
Drug: Bupivacaine Block
Bupivacaine local anesthesia block prior to start of FESS procedure.
Other Name: Local Block
Placebo Comparator: 2 - Placebo
Normal saline with Epi 1:100,000 (B block)
placebo is identical in appearance in comparison to active drug.
Other Name: Placebo saline injection
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00927888
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||David R. Drover||Stanford University|