Pain, PostoperativePhase 4NCT00927888
Postoperative Pain and Functional Patient Outcomes After Functional Endoscopic Sinus Surgery
A Phase 4 study testing Bupivacaine Block in people with Pain, Postoperative, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Bupivacaine Block
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Aug 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: The Effect of Preemptive Sphenopalatine Ganglion Block on Anesthetic Requirements, Postoperative Pain and Functional Patient Outcomes After Functional Endoscopic Sinus Surgery
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.
Read the 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.
- Conditions
- Pain, Postoperative
- Being tested
- Bupivacaine Block, Placebo
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine BlockDrug
Also called Local Block
Bupivacaine local anesthesia block prior to start of FESS procedure.
PlaceboDrug
Also called Placebo saline injection
placebo is identical in appearance in comparison to active drug.
| Study group | Role | What they receive |
|---|---|---|
| 1 - Bupivacaine Block | Active comparator | 3 ml of 0.25% Bupivacaine with Epi 1:100,000 (A block) Receives: Drug: Bupivacaine Block |
| 2 - Placebo | Placebo comparator | Normal saline with Epi 1:100,000 (B block) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: VAS Pain Score at 7 days
Secondary outcomes (1)
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
Measured: 1-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2009 (estimated)
- Study startAug 2007
- Primary completionMar 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Hospira, now a wholly owned subsidiary of Pfizer
- Responsible party
- Principal investigator, David R. Drover, Stanford University
- Investigators
- David R. Drover, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927888
- Sponsor's protocol ID
- SU-05072009-2478
- Status last verified
- Apr 2016
- First submitted
- 23 Jun 2009
- Last updated
- 19 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 22287376
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preemptive Sphenopalatine Ganglion Block on Anesthetic Requirements, Postoperative Pain and Functional Patient Outcomes After Functional Endoscopic Sinus Surgery
- ClinicalTrials.gov ID
- NCT00927888
- Acronym / sponsor ID
- SU-05072009-2478
- Conditions
- Pain, Postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Hospira, now a wholly owned subsidiary of Pfizer
- Study start
- Aug 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 25 Jun 2009 (estimated)
- Results
- Posted 4 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 - Bupivacaine Block | Active comparator | Drug: Bupivacaine Block3 ml of 0.25% Bupivacaine with Epi 1:100,000 (A block) |
| 2 - Placebo | Placebo comparator | Drug: PlaceboNormal saline with Epi 1:100,000 (B block) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine BlockAlso: Local BlockBupivacaine local anesthesia block prior to start of FESS procedure. | Drug | 1 - Bupivacaine Block |
| PlaceboAlso: Placebo saline injectionplacebo is identical in appearance in comparison to active drug. | Drug | 2 - Placebo |
Primary outcome
Postoperative Pain Assessed on Standard VAS Scale
Time frame: 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.
1 secondary outcome
SNOT-20 Surgical Outcome Score
Time frame: 1-day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22287376Cho 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David R. Drover principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine Block in people with Pain, Postoperative, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Assessed on Standard VAS Scale (time frame: VAS Pain Score at 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00927888, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2016.