Postop Pain Management in Pituitary Tumour Patients (POPPY)

Hamilton Health Sciences (HHS)

Status and phase: Enrolling; Phase 4

Conditions: Pain, Postoperative; Pituitary

Treatments: Drug: Placebo; Drug: Bupivacaine-Epinephrine 0.5%-1:200,000 Injectable Solution; Drug: Sham Comparator

Study type: Interventional

Funder types: Other

Identifiers

NCT06353529

17065

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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108 participants in 3 patient groups, including a placebo group

Bupivacaine injection

Experimental group

Description:

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.

Treatment:

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

Placebo Control

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Sham - no injection

Sham Comparator group

Description:

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.

Treatment:

Drug: Sham Comparator