Sphenopalatine Ganglion Block for Postop Pain Management (SPGB)

April 2, 2024 updated by: Hamilton Health Sciences Corporation

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. The aim is to improve patient outcomes and reduce the need for pain medication after surgery.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

52

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ms. Jessy Moore, MSc
  • Phone Number: 289-686-8827
  • Email: moorej@hhsc.ca

Study Contact Backup

  • Name: Dr. Kesava Reddy, MD
  • Phone Number: 905-521-2100
  • Email: reddy@hhsc.ca

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Hamilton General Hospital
        • Contact:
          • Ms. Jessy Moore, MSc
          • Phone Number: 289-686-8827
          • Email: moorej@hhsc.ca
        • Contact:
          • Dr. Kesava Reddy, MD
          • Phone Number: 905-521-2100
          • Email: reddy@hhsc.ca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bupivacaine injection
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.
Drug: 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
Placebo Comparator: Placebo Control
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.
Drug: Placebo
2mL injection bilateral (4mL total) 0.9% saline solution, 20G needle, sterile, sphenopalatine ganglion; nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, approximately 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative bleeding
Time Frame: through study completion, approximately 1 year
amount of post-op bleeding (mL) in first 24 hours
through study completion, approximately 1 year
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
through study completion, approximately 1 year
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
through study completion, approximately 1 year
Length of stay
Time Frame: through study completion, approximately 1 year
Length of hospital stay in hours
through study completion, approximately 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamilton Health Sciences Corporation

Investigators

  • Principal Investigator: Dr. Kesava Reddy, MD, Hamilton Health Sciences Corporatin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

March 26, 2024

First Submitted That Met QC Criteria

April 2, 2024

First Posted (Actual)

April 9, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17065

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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