Bilateral Sphenopalatine Ganglion Block Using Prilocaine Versus Lidocaine as Adjuvants to General Anesthesia During Endoscopic Hypophysectomy, Randomized Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 54
- Locations
- 2
- Primary Endpoint
- MAP
Study Overview
Brief Summary
Patients undergoing endoscopic surgeries for pituitary adenoma excision suffer from wide swings in blood pressure that might increase bleeding and interfere with the surgical field.
Local anethetic infiltration and regional nerve blocks have been used to provide better analgesia, control blood pressure and improve surgical field.
Limited studies evaluated shenopalatine ganglion block in pituitary adenoma excision with promising outcomes. The proposed study will compare the efficacy of two local anesthetics, prilocaine and lidocaine, for spenopalatine ganglion block in patients undergoing endoscopic pituitary adenoma excision. Evaluating the control of the intraoperative blood pressure and analgesic sparing are the main objectives of the proposed study.
Detailed Description
Pituitary adenoma excision through endoscopic sinus surgery has been evolving over the years. Though less traumatic less traumatic and less invasive than other approaches, hemodynamic variations during several phases of the surgey as nasal dissection pose challenges for anesthesiologists.
Regional techniques present appealing options for better control of blood pressure during periods of maximal surgical stimulation, they may as well provide a better surgical field. One of the regional techniques is the sphenopalatine ganglion bock where a local anesthetic is injected in the pterygopalatine fossa around the sphenopalatine ganglion. Thus, It blocks pain transmission through the branches of the trigeminal nerve.
The current study was designed to compare the effects of two local anesthetics, lidocaine versus prilocaine on intraoperative hemodynamics, surgical field and analgesia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with pituitary adenoma undergoing endoscopic hypophysectomy.
- •ASA physical status I and II.
- •Age above 21, below 45 years.
- •Male or female
Exclusion Criteria
- •Any patient below 21 years or above 45 years.
- •Patients suffering from any of the following conditions:
- •Disturbed conscious level.
- •Coagulation abnormalities.
- •Poorly controlled blood pressure and/or heart rate.
- •Increased intracranial tension.
- •Liver and kidney disorders.
- •Patients on anticoagulants and/or NSAIDS (non-steroidal anti- inflammatory drugs
- •Patients addicted to drugs and/or alcohol.
- •Patients with disturbed conscious level at the end of the surgery, GCS >14
Outcomes
Primary Outcomes
MAP
Time Frame: Mean arterial blood pressure in mmhg after 5 minutes of nasal dissection
mean arterial blood presssure 5 minutes after nasal dissection
Secondary Outcomes
- Mean arterial blood pressure(Before induction of Anesthesia, Before the block, 15 minutes after the block, 5 min of nasal dissection and every 30 minutes till the end of operation.)
- Systolic blood pressure(Systolic blood pressure in mmhg before induction of Anesthesia, Before the block, 15 minutes after the block, 5 min of nasal dissection and every 30 minutes till the end of operation.)
- Diastolic blood preesure(Diastolic blood pressure in mmhg before induction of Anesthesia, Before the block, 15 minutes after the block, 5 min of nasal dissection and every 30 minutes till the end of operation.)
- HR(Heart rate in beats/min before induction of Anesthesia, Before the block, 15 minutes after the block, 5 min of nasal dissection and every 30 minutes till the end of operation.)
- Patients needing propranolol(The number of patients throughout the study in the intraoperative period who received propranolol)
- Propranolol needed(The amount of propranolol in mg used throughout the surgery in each group)
- Patients needing phentolamine(The number of patients receiving phentolamine throughout the surgery in both groups)
- Phentolamine needed(Throughout the surgical time from the begining to the end of surgery)
- Surgeon satisfaction scale(10 minutes after the end of surgery.)
- Time to 1st analgesic requirement(The time in hours from emergence of anaesthesia till the request of first rescue analgesia in the first 24 hours after surgery)
- Blood loss(Throughout the surgical time from the begining to the end of surgery)
- Requirement for transfusion(Throughout the surgical time from the begining to the end of surgery)
- Fentanyl needed(Throughout the surgical time from the begining to the end of surgery)
- Total amount of fentanyl(Throughout the surgical time from the begining to the end of surgery)
Investigators
Rania Samir Fahmy
Associate professor
Kasr El Aini Hospital