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| Name | Class |
|---|---|
| Hospira, now a wholly owned subsidiary of Pfizer | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 - Bupivacaine Block | Active Comparator | 3 ml of 0.25% Bupivacaine with Epi 1:100,000 (A block) |
|
| 2 - Placebo | Placebo Comparator | Normal saline with Epi 1:100,000 (B block) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine Block | Drug | Bupivacaine local anesthesia block prior to start of FESS procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain Assessed on Standard VAS Scale | 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. | VAS Pain Score at 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| SNOT-20 Surgical Outcome Score | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David R. Drover | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22287376 | Result | Cho DY, Drover DR, Nekhendzy V, Butwick AJ, Collins J, Hwang PH. The effectiveness of preemptive sphenopalatine ganglion block on postoperative pain and functional outcomes after functional endoscopic sinus surgery. Int Forum Allergy Rhinol. 2011 May-Jun;1(3):212-8. doi: 10.1002/alr.20040. Epub 2011 Apr 13. |
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Having unilateral FESS
Stanford medical center
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 - Bupivacaine Block | Active treatment group with application of bupivacaine block before FESS. |
| FG001 | Group 2 - Placebo Saline Block | This group proceeded as per teh active treatment group but with blinded use of saline in the block syringe before start of FESS. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 Bupivacaine | Active treatment group with application of bupivacaine block before FESS. |
| BG001 | Group 2 - Saline Placebo Group | Saline substituted in block, placebo treatment group with application of saline block before FESS. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Postoperative Pain Assessed on Standard VAS Scale | 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. | Entire population of both groups. | Posted | Mean | Standard Deviation | units on a scale | VAS Pain Score at 7 days | VAS | Participants |
|
From time of enrollment until the 30-day follow-up visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 - Bupicaine Block | Active treatment group with application of bupivacaine block before FESS. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Drover, MD | Stanford University | 6507250364 | ddrover@stanford.edu |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| Placebo | Drug | placebo is identical in appearance in comparison to active drug. |
|
|
| 1-day |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Normal saline with Epi 1:100,000 (B block)
|
|
| Secondary | SNOT-20 Surgical Outcome Score | 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 | Entire study population included. | Posted | Mean | Standard Deviation | units on a scale | 1-day | Score | Participants |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Group 2 - Saline Placebo Block | Placebo treatment group with application of saline block before FESS. | 0 | 27 | 0 | 27 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |