PituitaryPhase 4POPPYNCT06353529
Postop Pain Management in Pituitary Tumour Patients
A Phase 4 study testing Bupivacaine-Epinephrine 0.5%-1:200,000 Injectable Solution in people with Pituitary and Pain, Postoperative, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
To assess the benefit of using an additional nerve block during minimally invasive pituitary surgery, to improve pain management after surgery. The medication (Bupivacaine) or a placebo (saline) will be injected during surgery and patients will be asked about their level of pain at multiple time points in the first 24… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pituitary, Pain, Postoperative
- What is being tested?
- Bupivacaine-Epinephrine 0.5%-1:200,000 Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteCanada
- Study dates
- 25 Nov 2024to Jul 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients (18 yrs or older)
- undergoing endonasal pituitary adenoma resection
Who cannot join
- Patients with pre-existing chronic pain conditions requiring antidepressants (serotonin reuptake inhibitors), benzodiazepines, gabapentin, or opioid drugs
- contraindications to the performance of SPGB such as known allergy to used medications
- chronic alcohol abuse
- uncontrolled systemic arterial hypertension
- severe kidney or liver diseases
- cardiomyopathies or sustained cardiac arrhythmias (permanent paroxystic atrial fibrillation or other sustained supraventricular rhythmic anomalies)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
Dr. Kesava Reddy, MD, 905-521-2100, reddy@hhsc.ca
Ms. Jessy Moore, MSc, 289-686-8827, moorej@hhsc.ca
About this study
Official title: Effect of Sphenopalatine Ganglion Block With Bupivacaine on Postoperative Pain in Patients Undergoing Endoscopic Pituitary Adenoma Resection
To assess the benefit of using an additional nerve block during minimally invasive pituitary surgery, to improve pain management after surgery. The medication (Bupivacaine) or a placebo (saline) will be injected during surgery and patients will be asked about their level of pain at multiple time points in the first 24 hours following surgery. Some patients will be randomized to a third, sham group that do not receive any additional injection. The aim is to improve patient outcomes and reduce the need for pain medication after surgery.
Read the detailed description
To further improve the quality of the early postoperative course, the investigators propose the use of the sphenopalatine ganglion (SPG) block (SPGB) for pain management in the context of an enhanced recovery after surgery (ERAS) protocol for minimally invasive (MIS) endoscopic transsphenoidal pituitary surgery. The SPG is the main sensory innervation to the nasal mucosa, and several studies have shown the analgesic efficacy of SPGB following sinus surgery and showed positive results for endoscopic sinus surgery. However, there is limited research on the use of SPGB in the context of pituitary surgery.
In this randomized placebo-controlled trial, the investigators aim to assess the benefit of SPGB with bupivacaine in addition to multimodal general anesthesia on pain management, after MIS pituitary surgery. The results of the trial will provide valuable insights into the potential benefits of SPGB and its optimal use for pituitary surgery.
- Conditions
- Pituitary, Pain, Postoperative
- Being tested
- Bupivacaine-Epinephrine 0.5%-1:200,000 Injectable Solution, Placebo, Sham Comparator
- Keywords
- Nerve block, Bupivacaine, Sphenopalatine Ganglion
- Medical subject headings
- Pituitary Diseases, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine-Epinephrine 0.5%-1:200,000 Injectable SolutionDrug
2mL injection bilateral (4mL total) of 0.5% bupivacaine with 1:200,000 epinephrine solution, 20G needle, sterile, sphenopalatine ganglion; nerve block
PlaceboDrug
2mL injection bilateral (4mL total) 0.9% saline solution, 20G needle, sterile, sphenopalatine ganglion; nerve block
Sham ComparatorDrug
Participants receive no additional study injections
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine injection | Experimental | This group will receive bilateral injection of 0.5% bupivacaine with 1:200,000 epinephrine using a 20G needle and comprising 2mL of fluid on each side (4mL total) into the sphenopalatine ganglion. Receives: Drug: Bupivacaine-Epinephrine 0.5%-1:200,000 Injectable Solution |
| Placebo Control | Placebo comparator | This group will receive bilateral injection of 0.9% saline solution using a 20G needle and comprising 2mL of fluid on each side (4mL total) into the sphenopalatine ganglion. Receives: Drug: Placebo |
| Sham - no injection | Sham comparator | Participants randomized to this arm will not receive any additional study injections and will undergo the current standard procedure for patients undergoing endoscopic endonasal surgery. Receives: Drug: Sham Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain score
Pain score, measured by visual analog scale (scale of 0-10) at 6, 12 and 24 hours post-op
Measured: through study completion, approximately 1 year
Secondary outcomes (4)
Post-operative bleeding
amount of post-op bleeding (mL) in first 24 hours
Measured: through study completion, approximately 1 year
Post-operative complications
record presence of post-op nausea/vomiting, headache, sore throat, difficulty swallowing in first 24 hours
Measured: through study completion, approximately 1 year
Analgesic requirement
List and dose of analgesics administered to patient in first 24 hours or time of discharge, whichever comes first
Measured: through study completion, approximately 1 year
Length of stay
Length of hospital stay in hours
Measured: through study completion, approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start25 Nov 2024
- Primary completionApr 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PituitaryStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Kesava Reddy, MD, Principal investigator, Hamilton Health Sciences Corporatin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353529
- Sponsor's protocol ID
- 17065
- Acronym
- POPPY
- Status last verified
- Sep 2025
- First submitted
- 26 Mar 2024
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Patient data will be de-identified and the data will be analyzed as a whole before becoming available to other researchers. De-identified IPD may be shared with other researchers if necessary based on occurrence of adverse events occurrence, circumstantial findings, etc.
Publications
Morisse M, Rysman B, Szymanski C, Fackeure R, Mouawad F, Mortuaire G. A randomized placebo-controlled trial assessing sphenopalatine ganglion block in endoscopic sinus surgery. Int Forum Allergy Rhinol. 2021 Sep;11(9):1384-1386. doi: 10.1002/alr.22804. Epub 2021 May 19. No abstract available.
PubMed 34013619Rezaeian A, Hashemi SM, Dokhanchi ZS. Effect of Sphenopalatine Ganglion Block With Bupivacaine on Postoperative Pain in Patients Undergoing Endoscopic Sinus Surgery. Allergy Rhinol (Providence). 2019 Jan 23;10:2152656718821282. doi: 10.1177/2152656718821282. eCollection 2019 Jan-Dec.
PubMed 30719401Kim DH, Kang H, Hwang SH. The Effect of Sphenopalatine Block on the Postoperative Pain of Endoscopic Sinus Surgery: A Meta-analysis. Otolaryngol Head Neck Surg. 2019 Feb;160(2):223-231. doi: 10.1177/0194599818805673. Epub 2018 Oct 9.
PubMed 30296912Kesimci E, Ozturk L, Bercin S, Kiris M, Eldem A, Kanbak O. Role of sphenopalatine ganglion block for postoperative analgesia after functional endoscopic sinus surgery. Eur Arch Otorhinolaryngol. 2012 Jan;269(1):165-9. doi: 10.1007/s00405-011-1702-z. Epub 2011 Jul 8.
PubMed 21739090Wang P. The efficacy of sphenopalatine ganglion block for pain management after endoscopic sinus surgery: a meta-analysis of randomized controlled studies. Eur Arch Otorhinolaryngol. 2021 Aug;278(8):2681-2687. doi: 10.1007/s00405-020-06484-9. Epub 2021 Jan 3.
PubMed 33388988
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sphenopalatine Ganglion Block With Bupivacaine on Postoperative Pain in Patients Undergoing Endoscopic Pituitary Adenoma Resection
- ClinicalTrials.gov ID
- NCT06353529
- Acronym / sponsor ID
- POPPY / 17065
- Conditions
- Pituitary, Pain, Postoperative
- Keywords
- Nerve block, Bupivacaine, Sphenopalatine Ganglion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 9 Apr 2024 (actual)
- 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.
To assess the benefit of using an additional nerve block during minimally invasive pituitary surgery, to improve pain management after surgery. The medication (Bupivacaine) or a placebo (saline) will be injected during surgery and patients will be asked about their level of pain at multiple time points in the first 24 hours following surgery. Some patients will be randomized to a third, sham group that do not receive any additional injection. The aim is to improve patient outcomes and reduce the need for pain medication after surgery.
Detailed description
To further improve the quality of the early postoperative course, the investigators propose the use of the sphenopalatine ganglion (SPG) block (SPGB) for pain management in the context of an enhanced recovery after surgery (ERAS) protocol for minimally invasive (MIS) endoscopic transsphenoidal pituitary surgery. The SPG is the main sensory innervation to the nasal mucosa, and several studies have shown the analgesic efficacy of SPGB following sinus surgery and showed positive results for endoscopic sinus surgery. However, there is limited research on the use of SPGB in the context of pituitary surgery.
In this randomized placebo-controlled trial, the investigators aim to assess the benefit of SPGB with bupivacaine in addition to multimodal general anesthesia on pain management, after MIS pituitary surgery. The results of the trial will provide valuable insights into the potential benefits of SPGB and its optimal use for pituitary surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine injection | Experimental | Drug: Bupivacaine-Epinephrine 0.5%-1:200,000 Injectable SolutionThis group will receive bilateral injection of 0.5% bupivacaine with 1:200,000 epinephrine using a 20G needle and comprising 2mL of fluid on each side (4mL total) into the sphenopalatine ganglion. |
| Placebo Control | Placebo comparator | Drug: PlaceboThis group will receive bilateral injection of 0.9% saline solution using a 20G needle and comprising 2mL of fluid on each side (4mL total) into the sphenopalatine ganglion. |
| Sham - no injection | Sham comparator | Drug: Sham ComparatorParticipants randomized to this arm will not receive any additional study injections and will undergo the current standard procedure for patients undergoing endoscopic endonasal surgery. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult patients (18 yrs or older)
- undergoing endonasal pituitary adenoma resection
Key exclusion criteria (6 listed)
- Patients with pre-existing chronic pain conditions requiring antidepressants (serotonin reuptake inhibitors), benzodiazepines, gabapentin, or opioid drugs
- contraindications to the performance of SPGB such as known allergy to used medications
- chronic alcohol abuse
- uncontrolled systemic arterial hypertension
- severe kidney or liver diseases
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-Epinephrine 0.5%-1:200,000 Injectable Solution2mL injection bilateral (4mL total) of 0.5% bupivacaine with 1:200,000 epinephrine solution, 20G needle, sterile, sphenopalatine ganglion; nerve block | Drug | Bupivacaine injection |
| Placebo2mL injection bilateral (4mL total) 0.9% saline solution, 20G needle, sterile, sphenopalatine ganglion; nerve block | Drug | Placebo Control |
| Sham ComparatorParticipants receive no additional study injections | Drug | Sham - no injection |
Primary outcome
Post-operative pain score
Time frame: through study completion, approximately 1 year
Pain score, measured by visual analog scale (scale of 0-10) at 6, 12 and 24 hours post-op
4 secondary outcomes
Post-operative bleeding
Time frame: through study completion, approximately 1 year
Post-operative complications
Time frame: through study completion, approximately 1 year
Analgesic requirement
Time frame: through study completion, approximately 1 year
Length of stay
Time frame: through study completion, approximately 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Results publication: PubMed 34013619Morisse M, Rysman B, Szymanski C, Fackeure R, Mouawad F, Mortuaire G. A randomized placebo-controlled trial assessing sphenopalatine ganglion block in endoscopic sinus surgery. Int Forum Allergy Rhinol. 2021 Sep;11(9):1384-1386. doi: 10.1002/alr.22804. Epub 2021 May 19. No abstract available.
- Results publication: PubMed 30719401Rezaeian A, Hashemi SM, Dokhanchi ZS. Effect of Sphenopalatine Ganglion Block With Bupivacaine on Postoperative Pain in Patients Undergoing Endoscopic Sinus Surgery. Allergy Rhinol (Providence). 2019 Jan 23;10:2152656718821282. doi: 10.1177/2152656718821282. eCollection 2019 Jan-Dec.
- Results publication: PubMed 30296912Kim DH, Kang H, Hwang SH. The Effect of Sphenopalatine Block on the Postoperative Pain of Endoscopic Sinus Surgery: A Meta-analysis. Otolaryngol Head Neck Surg. 2019 Feb;160(2):223-231. doi: 10.1177/0194599818805673. Epub 2018 Oct 9.
- Results publication: PubMed 21739090Kesimci E, Ozturk L, Bercin S, Kiris M, Eldem A, Kanbak O. Role of sphenopalatine ganglion block for postoperative analgesia after functional endoscopic sinus surgery. Eur Arch Otorhinolaryngol. 2012 Jan;269(1):165-9. doi: 10.1007/s00405-011-1702-z. Epub 2011 Jul 8.
- Results publication: PubMed 33388988Wang P. The efficacy of sphenopalatine ganglion block for pain management after endoscopic sinus surgery: a meta-analysis of randomized controlled studies. Eur Arch Otorhinolaryngol. 2021 Aug;278(8):2681-2687. doi: 10.1007/s00405-020-06484-9. Epub 2021 Jan 3.
- Individual participant dataSharing planned: Undecided. Patient data will be de-identified and the data will be analyzed as a whole before becoming available to other researchers. De-identified IPD may be shared with other researchers if necessary based on occurrence of adverse events occurrence, circumstantial findings, etc.
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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.
Dr. Kesava Reddy, MD principal investigator
Hamilton Health Sciences Corporatin
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-Epinephrine 0.5%-1:200,000 Injectable Solution in people with Pituitary and Pain, Postoperative, run by Hamilton Health Sciences Corporation at 1 site in Canada.
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 6 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: looking for participants now, as of the sponsor's last update on 12 Mar 2026. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Kesava Reddy, MD (905-521-2100, reddy@hhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative pain score (time frame: through study completion, approximately 1 year). 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 NCT06353529, which also lists 5 linked publications.
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 12 Mar 2026.