Pain, Postoperative
Conditions
Brief 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.
Detailed description
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.
Interventions
Bupivacaine local anesthesia block prior to start of FESS procedure.
DRUGPlacebo
placebo is identical in appearance in comparison to active drug.
Sponsors
Hospira, now a wholly owned subsidiary of Pfizer
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Assessed on Standard VAS Scale | VAS Pain Score at 7 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SNOT-20 Surgical Outcome Score | 1-day | 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 |
Countries
United States
Participant flow
Recruitment details
Stanford medical center
Pre-assignment details
Having unilateral FESS
Participants by arm
| Arm | Count |
|---|---|
| Group 1 Bupivacaine Active treatment group with application of bupivacaine block before FESS. | 29 |
| Group 2 - Saline Placebo Group Saline substituted in block, placebo treatment group with application of saline block before FESS. | 27 |
| Total | 56 |
Baseline characteristics
| Characteristic | Group 2 - Saline Placebo Group | Group 1 Bupivacaine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical >=65 years | 5 Participants | 2 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 26 Participants | 47 Participants |
| Age, Continuous | 42 years | 49 years | 45 years |
| Region of Enrollment United States | 27 participants | 29 participants | 56 participants |
| Sex: Female, Male Female | 7 Participants | 8 Participants | 15 Participants |
| Sex: Female, Male Male | 20 Participants | 21 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 29 | 0 / 27 |
| serious Total, serious adverse events | 0 / 29 | 0 / 27 |
Outcome results
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.
Time frame: VAS Pain Score at 7 days
Population: Entire population of both groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 - Bupivacaine Block | Postoperative Pain Assessed on Standard VAS Scale | 0.48 units on a scale | Standard Deviation 0.23 |
| 2 - Placebo | Postoperative Pain Assessed on Standard VAS Scale | 1.12 units on a scale | Standard Deviation 0.3 |
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
Time frame: 1-day
Population: Entire study population included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 - Bupivacaine Block | SNOT-20 Surgical Outcome Score | 1.76 units on a scale | Standard Deviation 0.2 |
| 2 - Placebo | SNOT-20 Surgical Outcome Score | 1.67 units on a scale | Standard Deviation 0.2 |