Functional Endoscopic Sinus Surgery (FESS)Phase 3NCT03013361
Ropivacaine and Bupivacaine in Sphenopalatine Ganglion Block in Sinus Surgery
A Phase 3 study testing Bupivacaine, Ropivacaine and Normal Saline in people with Functional Endoscopic Sinus Surgery (FESS), run by Post Graduate Institute of Medical Education and Research, Chandigarh.
Trial summary
Postoperative analgesia after FESS can be achieved through opioids, NSAIDs, topical or infiltration of local anaesthetic and regional techniques like sphenopalatine ganglion (SPG) block, infraorbital nerve block and nasociliary block. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Functional Endoscopic Sinus Surgery (FESS)
- What is being tested?
- Bupivacaine, Ropivacaine and Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jul 2013to Dec 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 60 American Society of Anesthesiologists (ASA) physical status I and II patients
- aged 18-60 years scheduled to undergo elective functional endoscopic sinus surgery for sinonasal disease such as rhinosinusitis, polyps and deviated nasal septum were enrolled
Who cannot join
- Severe cardiovascular, pulmonary, hepatic, renal, neurologic or metabolic disease or coagulopathy
- History of allergy to any of the medications being used in the study
- Previous surgery for sinonasal disease
- Pre-existing chronic pain not related to chronic rhinosinusitis
- Taking prescription pain medications or antidepressants
- Chronic alcohol or drug abuse
- Inability to comprehend the study protocol
- Pregnancy
About this study
Official title: Comparison Ropivacaine and Bupivacaine in Sphenopalatine Ganglion Block for Postoperative Analgesia After Functional Endoscopic Sinus Surgery: A Randomized Controlled Trial
Postoperative analgesia after FESS can be achieved through opioids, NSAIDs, topical or infiltration of local anaesthetic and regional techniques like sphenopalatine ganglion (SPG) block, infraorbital nerve block and nasociliary block. As the current evidences regarding the benefit of SPG block after FESS is controversial, efficacy of sphenopalatine ganglion block will be evaluated using bupivacaine or ropivacaine as local anaesthetic in adult patients undergoing FESS under general anaesthesia in this study.
Read the detailed description
Functional endoscopic sinus surgery (FESS) is a minimally invasive and safe technique for the treatment of sinonasal disease. Although it is a minimally invasive and less traumatic procedure, it is usually associated with pain of mild to moderate intensity which reaches its maximum level in the first few postoperative hours. However, even low-level postoperative pain may be associated with delayed functional recovery and it frequently contributes to dissatisfaction with the procedure delay in return to work and readmission after surgery. Postoperative analgesia after FESS can be achieved through opioids, NSAIDs, topical or infiltration of local anaesthetic and regional techniques like sphenopalatine ganglion (SPG) block, infraorbital nerve block and nasociliary block. As the sensory innervations of the SPG supplies the nasal turbinates, nasopharynx and palate, SPG block is expected to provide perioperative analgesia after FESS. Integration of regional anaesthesia with general anaesthesia technique can provide a better hemodynamic control, less perioperative opioid use, less bleeding and higher level of patients' satisfaction. Reduction in surgical bleeding in FESS can improve surgical field and also surgeons' satisfaction and a reduced opioid use may be translated into a less postoperative nausea \& vomiting, rapid recovery and early hospital discharge. But, the current evidences regarding the benefit of SPG block after FESS is controversial. In this randomized controlled trial, efficacy of sphenopalatine ganglion block will be evaluated using bupivacaine or ropivacaine as local anaesthetic in adult patients undergoing FESS under general anaesthesia.
- Being tested
- Bupivacaine, Ropivacaine, Normal Saline
- Keywords
- ropivacaine, bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called Anawin
Post operative pain control
RopivacaineDrug
Also called Ropin
Post operative pain control
Normal SalineOther
Also called Saline
Acts as comparator
| Study group | Role | What they receive |
|---|---|---|
| Group B (n=20) | Active comparator | Group B (n=20): The patients in this group were infiltrated with 3 mL of 0.5% bupivacaine. Receives: Drug: Bupivacaine |
| Group R (n=20): | Active comparator | Group R (n=20): The patients in this group were infiltrated with 3 mL of 0.5% ropivacaine. Receives: Drug: Ropivacaine |
| Group S (n=20, Control): | Placebo comparator | Group S (n=20, Control): The patients in this group were infiltrated with 3 mL of normal saline. Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary aim of the study was to assess the change in visual analogue scale comparing the effect of bilateral sphenopalatine ganglion block with bupivacaine and ropivacaine for postoperative analgesia after functional endoscopic sinus surgery
Measured: 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours and 8 hours thereafter.
Secondary outcomes (2)
Time to first administration of rescue analgesia was recorded.
Measured: 8 hours
Patient satisfaction score
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study startJul 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Functional Endoscopic Sinus Surgery (FESS)Studies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Sameer Sethi, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Sameer Sethi, MD, Principal investigator, PGIMER, Chandigarh,India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03013361
- Sponsor's protocol ID
- 9157/PG2Trg/2012/15727
- Status last verified
- Jan 2017
- First submitted
- 3 Jan 2017
- Last updated
- 6 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
1. Ali A, Sakr S, Rahman A. Bilateral sphenopalatine ganglion block as adjuvant to general anaesthesia during endoscopic trans-nasal resection of pituitary adenoma. Egypt J Anaesth 2010;26;273-280. 2. Friedman M, Venkatesan TK, Lang D, Caldarelli DD. Bupivacaine for postoperative analgesia following endoscopic sinus surgery. Laryngoscope 1996;106:1382-1385. 3. Bicer C, Eskıtascıoglu T, Aksu R, Ulgey A, Yildiz K, Madenoglu H. Comparison of Preincisional Infiltrated Levobupivacaine and Ropivacaine for Acute Postoperative Pain Relief After Septorhinoplasty. Curr Ther Res Clin Exp 2011;72:13-22. 4. Fernandes SV. Postoperative care in functional endoscopic sinus surgery. Laryngoscope 1999;109:945-948.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Ropivacaine and Bupivacaine in Sphenopalatine Ganglion Block for Postoperative Analgesia After Functional Endoscopic Sinus Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03013361
- Acronym / sponsor ID
- 9157/PG2Trg/2012/15727
- Keywords
- ropivacaine, bupivacaine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 6 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative analgesia after FESS can be achieved through opioids, NSAIDs, topical or infiltration of local anaesthetic and regional techniques like sphenopalatine ganglion (SPG) block, infraorbital nerve block and nasociliary block. As the current evidences regarding the benefit of SPG block after FESS is controversial, efficacy of sphenopalatine ganglion block will be evaluated using bupivacaine or ropivacaine as local anaesthetic in adult patients undergoing FESS under general anaesthesia in this study.
Detailed description
Functional endoscopic sinus surgery (FESS) is a minimally invasive and safe technique for the treatment of sinonasal disease. Although it is a minimally invasive and less traumatic procedure, it is usually associated with pain of mild to moderate intensity which reaches its maximum level in the first few postoperative hours. However, even low-level postoperative pain may be associated with delayed functional recovery and it frequently contributes to dissatisfaction with the procedure delay in return to work and readmission after surgery. Postoperative analgesia after FESS can be achieved through opioids, NSAIDs, topical or infiltration of local anaesthetic and regional techniques like sphenopalatine ganglion (SPG) block, infraorbital nerve block and nasociliary block. As the sensory innervations of the SPG supplies the nasal turbinates, nasopharynx and palate, SPG block is expected to provide perioperative analgesia after FESS. Integration of regional anaesthesia with general anaesthesia technique can provide a better hemodynamic control, less perioperative opioid use, less bleeding and higher level of patients' satisfaction. Reduction in surgical bleeding in FESS can improve surgical field and also surgeons' satisfaction and a reduced opioid use may be translated into a less postoperative nausea \& vomiting, rapid recovery and early hospital discharge. But, the current evidences regarding the benefit of SPG block after FESS is controversial. In this randomized controlled trial, efficacy of sphenopalatine ganglion block will be evaluated using bupivacaine or ropivacaine as local anaesthetic in adult patients undergoing FESS under general anaesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group B (n=20) | Active comparator | Drug: BupivacaineGroup B (n=20): The patients in this group were infiltrated with 3 mL of 0.5% bupivacaine. |
| Group R (n=20): | Active comparator | Drug: RopivacaineGroup R (n=20): The patients in this group were infiltrated with 3 mL of 0.5% ropivacaine. |
| Group S (n=20, Control): | Placebo comparator | Other: Normal SalineGroup S (n=20, Control): The patients in this group were infiltrated with 3 mL of normal saline. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 60 American Society of Anesthesiologists (ASA) physical status I and II patients
- aged 18-60 years scheduled to undergo elective functional endoscopic sinus surgery for sinonasal disease such as rhinosinusitis, polyps and deviated nasal septum were enrolled
Key exclusion criteria (8 listed)
- Severe cardiovascular, pulmonary, hepatic, renal, neurologic or metabolic disease or coagulopathy
- History of allergy to any of the medications being used in the study
- Previous surgery for sinonasal disease
- Pre-existing chronic pain not related to chronic rhinosinusitis
- Taking prescription pain medications or antidepressants
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 |
|---|---|---|
| BupivacaineAlso: AnawinPost operative pain control | Drug | Group B (n=20) |
| RopivacaineAlso: RopinPost operative pain control | Drug | Group R (n=20): |
| Normal SalineAlso: SalineActs as comparator | Other | Group S (n=20, Control): |
Primary outcome
Primary aim of the study was to assess the change in visual analogue scale comparing the effect of bilateral sphenopalatine ganglion block with bupivacaine and ropivacaine for postoperative analgesia after functional endoscopic sinus surgery
Time frame: 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours and 8 hours thereafter.
2 secondary outcomes
Time to first administration of rescue analgesia was recorded.
Time frame: 8 hours
Patient satisfaction score
Time frame: 8 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
- Results publication1. Ali A, Sakr S, Rahman A. Bilateral sphenopalatine ganglion block as adjuvant to general anaesthesia during endoscopic trans-nasal resection of pituitary adenoma. Egypt J Anaesth 2010;26;273-280. 2. Friedman M, Venkatesan TK, Lang D, Caldarelli DD. Bupivacaine for postoperative analgesia following endoscopic sinus surgery. Laryngoscope 1996;106:1382-1385. 3. Bicer C, Eskıtascıoglu T, Aksu R, Ulgey A, Yildiz K, Madenoglu H. Comparison of Preincisional Infiltrated Levobupivacaine and Ropivacaine for Acute Postoperative Pain Relief After Septorhinoplasty. Curr Ther Res Clin Exp 2011;72:13-22. 4. Fernandes SV. Postoperative care in functional endoscopic sinus surgery. Laryngoscope 1999;109:945-948.
- Individual participant dataSharing planned: No
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Screening
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.
Sameer Sethi, MD principal investigator
PGIMER, Chandigarh,India
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bupivacaine, Ropivacaine and Normal Saline in people with Functional Endoscopic Sinus Surgery (FESS), run by Post Graduate Institute of Medical Education and Research, Chandigarh.
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 2 inclusion and 8 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 6 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary aim of the study was to assess the change in visual analogue scale comparing the effect of bilateral sphenopalatine ganglion block with bupivacaine and ropivacaine for postoperative analgesia after functional endoscopic sinus surgery (time frame: 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours and 8 hours thereafter.). 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 NCT03013361, 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 6 Jan 2017; AzTrials last refreshed its copy on 8 Nov 2026.