Postop Pain Management in Pituitary Tumour Patients
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Bupivacaine-Epinephrine 0.5%-1:200,000 Injectable Solution, Placebo, Sham Comparator.
- Кому может быть актуально
- Состояния в реестре: Pituitary, Pain, Postoperative. Базовые параметры: 18 лет — 100 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Канада
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Effect of Sphenopalatine Ganglion Block With Bupivacaine on Postoperative Pain in Patients Undergoing Endoscopic Pituitary Adenoma Resection
Обзор
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.
Подробное описание
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.
Вмешательства
- Препарат Bupivacaine-Epinephrine 0.5%-1:200,000 Injectable Solution
2mL injection bilateral (4mL total) of 0.5% bupivacaine with 1:200,000 epinephrine solution, 20G needle, sterile, sphenopalatine ganglion; nerve block - Препарат Placebo
2mL injection bilateral (4mL total) 0.9% saline solution, 20G needle, sterile, sphenopalatine ganglion; nerve block - Препарат Sham Comparator
Participants receive no additional study injections
Первичные конечные точки
- Post-operative pain score [Срок оценки: through study completion, approximately 1 year]
Вторичные конечные точки (4)
- Post-operative bleeding [Срок оценки: through study completion, approximately 1 year]
- Post-operative complications [Срок оценки: through study completion, approximately 1 year]
- Analgesic requirement [Срок оценки: through study completion, approximately 1 year]
- Length of stay [Срок оценки: through study completion, approximately 1 year]
Критерии участия
Критерии включения
- adult patients (18 yrs or older)
- undergoing endonasal pituitary adenoma resection
Критерии исключения
- 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)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Канада · 1 центр
- Hamilton General Hospital — Hamilton
Публикации
- 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. PMID 34013619
- Rezaeian 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. PMID 30719401
- Kim 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. PMID 30296912
- Kesimci 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. PMID 21739090
- Wang 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. PMID 33388988
Идентификаторы
NCT: NCT06353529 · 17065