Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06353529

Postop Pain Management in Pituitary Tumour Patients

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Pituitary Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hypothalamic Diseases Nervous System Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Pituitary Diseases Postoperative Complications Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult patients (18 yrs or older)
  • undergoing endonasal pituitary adenoma resection

Exclusion criteria

  • 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)

Treatment and study plan

Bupivacaine-Epinephrine 0.5%-1:200,000 Injectable Solution

Drug

2mL injection bilateral (4mL total) of 0.5% bupivacaine with 1:200,000 epinephrine solution, 20G needle, sterile, sphenopalatine ganglion; nerve block

Placebo

Drug

2mL injection bilateral (4mL total) 0.9% saline solution, 20G needle, sterile, sphenopalatine ganglion; nerve block

Sham Comparator

Drug

Participants receive no additional study injections

Primary outcomes

  1. 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

Secondary outcomes

  1. Post-operative bleeding

    Time frame: through study completion, approximately 1 year

    amount of post-op bleeding (mL) in first 24 hours

  2. Post-operative complications

    Time frame: through study completion, approximately 1 year

    record presence of post-op nausea/vomiting, headache, sore throat, difficulty swallowing in first 24 hours

  3. Analgesic requirement

    Time frame: through study completion, approximately 1 year

    List and dose of analgesics administered to patient in first 24 hours or time of discharge, whichever comes first

  4. Length of stay

    Time frame: through study completion, approximately 1 year

    Length of hospital stay in hours

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Kesava Reddy, MD

CONTACT

[email protected]

905-521-2100

Ms. Jessy Moore, MSc

CONTACT

[email protected]

289-686-8827

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Registry information

Official study title

Effect of Sphenopalatine Ganglion Block With Bupivacaine on Postoperative Pain in Patients Undergoing Endoscopic Pituitary Adenoma Resection

Acronym: POPPY

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 9, 2024
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.