The Cardiovascular Changes Associated With Septal Local Anaesthesia

An Observational Study of the Cardiovascular Response to Infiltration of Local Anaesthetic Into the Nasal Septum in Patients Undergoing Trans-sphenoidal Resection of a Pituitary Lesion

The purpose of this study is to determine the effects on the heart of injecting local anaesthetic into the nose prior to surgery on the pituitary gland?

Study Overview

• Status: Completed
• Conditions: Pituitary Diseases; Hypothalamic Neoplasms; Anesthesia, Local
• Intervention / Treatment: Procedure: Pituitary surgery; Drug: local anaesthetic injection

Detailed Description

People sometimes require surgery on their pituitary gland. This is a gland at the base of your brain which secretes hormones. At the Royal Hallamshire Hospital the investigators are currently conducting a study into the effects of local anaesthetic (a medicine which causes numbness) injection on patients undergoing this particular type of operation.

After patients are anaesthetised (asleep) but before surgery starts the surgeon injecst a local anaesthetic solution into the nose. This is routine practice and is done to provide pain relief afterwards and also to decrease the amount of bleeding during the operation to ensure that the surgeon has a good view.

The investigators have known for a long time that local anaesthetic affects the heart rate and blood pressure, however the investigators would like to describe exactly how, in much more detail.

• Study Type: Observational
• Enrollment (Actual): 15

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing trans-sphenoidal resection of a pituitary tumour.

Description

Inclusion Criteria:

• Any adult patient undergoing trans-sphenoidal pituitary surgery.

Exclusion Criteria:

• Under 16 years of age, pregnancy, uncontrolled hypertension, allergy to any local anaesthetic, patient refusal or revision pituitary surgery.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pituitary Surgery; Patients having pituitary gland surgery Inclusion criteria - Any adult patient undergoing trans-sphenoidal pituitary surgery. Exclusion criteria - Under 16 years of age, pregnancy, uncontrolled hypertension, allergy to any local anaesthetic, patient refusal or revision pituitary surgery	Procedure: Pituitary surgery; Trans-sphenoidal resection of a pituitary gland lesion.; Drug: local anaesthetic injection; The surgeon infiltrates the nasal septum with local anaesthesia as per usual practice. This consists of Moffet's solution and lidocaine with adrenaline (1:200,000).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in blood pressure after administration of local anaesthesia	Changes in mean arterial pressure from baseline after infiltration of local anaesthetic.	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in heart rate after administration of local anaesthesia	Changes in mean arterial pressure from baseline after infiltration of local anaesthetic.	5 minutes
Change in cardiac output after administration of local anaesthesia	Changes in cardiac output from baseline after infiltration of local anaesthetic.	5 minutes
Change in systemic vascular resistance after administration of local anaesthesia	Changes in systemic vascular resistance from baseline after infiltration of local anaesthetic.	5 minutes

Collaborators and Investigators

• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
• Investigators: Study Chair: Matthew D Wiles, FRCA FFICM, Sheffield Teaching Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (ACTUAL): June 1, 2015
• Study Completion (ACTUAL): June 1, 2015

Study Registration Dates

• First Submitted: November 20, 2015
• First Submitted That Met QC Criteria: April 28, 2017
• First Posted (ACTUAL): May 3, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 3, 2017
• Last Update Submitted That Met QC Criteria: April 28, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Hypothalamic Diseases; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Pituitary Diseases; Hypothalamic Neoplasms; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: STH17059