Postoperative Pain and Headache After Craniotomy

Study Overview
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Brief Summary
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The purpose of this study is to assess the outcomes of an anesthetic technique which is not synthetic opioid based, on postoperative pain modulation and development of post craniotomy headache against a cohort of patients where an opioid based standard anesthetic technique was used for craniotomy. The hypothesis that is tested is that the use of agents other than synthetic short acting opioids will reduce the amount of postoperative pain and the incidence of headache after surgery.

Detailed Description
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120 ASA physical status I to III patients, ages 18 to 75, who are to undergo supratentorial, infratentorial or skull base tumor resection will be included in this randomized control study. The Preadmission Testing is done for the most part in the same day the patient has an ENT clinic appointment or just Anesthesia preadmission screening date. This is the day that patient will come to the clinic for pre-admission testing, days before the plan procedure. They will meet with Anesthesiology department clinician. Having the consent process started in the preadmission Clinic with Anesthesiology clinician will be better for the patient to process and understand the information about the study before agreeing to participate. If the patient is only coming In the ENT Clinic then the patient will be approached about the study in the ENT clinic. At the day of the surgery if the patent have any additional question or any unclear information, the PI or the Co-PI will answer before the patient signing the consent. Patients who are pregnant, undergoing emergency, neurovascular, or trigeminal nerve pain procedures, those unable to give informed consent, or who were extremely debilitated (ASA physical status IV or V) in liver or renal failure will be excluded from the study. A mini mental status exam will be performed on the day of surgery before the patient presents to the operating room. All patients will receive a general anesthetic consisting of propofol 2 mg/kg intravenously (IV) and fentanyl 2 mcg/kg IV induction of anesthesia followed by maintenance anesthetic consisting of desflurane 5% to 6% end tidal concentration. All patients will be given rocuronium 0.1 mg/kg/IV or succinylcholine 1.0 mg/kg IV to facilitate intubation along with a 70/30 mixture of air in 02. Patients will be assigned via a computer generated randomization table before surgery to receive one of two anesthetic techniques perioperatively. Group 1 patients will be given an infusion of remifentanil 0.15-0.25 mcg/kg/min as part of their intraoperative anesthetic regimen. The infusion will be maintained until the end of surgery and will be discontinued upon emergence. Prior to emergence, 100-200 mcg of fentanyl will be titrated for additional analgesia after emergence. Group 2 individuals will receive an identical anesthetic without the addition of remifentanil.. They will also be given methadone 0.2 mg/kg IV at the beginning of the anesthetic. A lidocaine bolus of 1.5 mg/kg will be given with induction of anesthesia followed by an infusion of lidocaine at 2 mg/kg/hr until the end of surgery.

Official Title
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Postoperative Pain and Headache After Craniotomy

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Methadone
* Drug: Standard of Care


Participation Criteria
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Eligibility Criteria
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Patient Inclusion Criteria: Undergoing Supratentorial, Infratentorial or Skull Base Tumor resection. Age 18 to 75 ASA physical status I to III Patient Exclusion Criteria: ASA physical status IV or V Allergies to the medication used for the study Pregnant Undergoing Emergency, Neurovascular, or Trigeminal Nerve pain procedure Liver or renal failure Unable to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care<br>Standard of Care patients will be given an infusion of remifentanil 0.15-0.25 mcg/kg/min as part of their intraoperative anesthetic regimen. The infusion will be maintained until the end of surgery and will be discontinued upon emergence. Prior to emergence, 100-200 mcg of fentanyl will be titrated for additional analgesia after emergence. | Drug: Standard of Care<br>* Standard of Care patients will be given an infusion of remifentanil 0.15-0.25 mcg/kg/min as part of their intraoperative anesthetic regimen. The infusion will be maintained until the end of surgery and will be discontinued upon emergence. Prior to emergence, 100-200 mcg of fentanyl will be titrated for additional analgesia after emergence.<br>|
| Experimental: Methadone<br>Individuals in this group will receive an identical anesthetic without the addition of remifentanil. They will be given methadone 0.2 mg/kg IV at the beginning of the anesthetic. A lidocaine bolus of 1.5 mg/kg will be given with induction of anesthesia followed by an infusion of lidocaine at 2 mg/kg/hr until the end of surgery. | Drug: Methadone<br>* Individuals in this group will receive an identical anesthetic without the addition of remifentanil. They will be given methadone 0.2 mg/kg IV at the beginning of the anesthetic. A lidocaine bolus of 1.5 mg/kg will be given with induction of anesthesia followed by an infusion of lidocaine at 2 mg/kg/hr until the end of surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post craniotomy pain | Assessed via a Verbal Analog Scale from 0-10 with 0 being no pain and 10 being the worst pain ever experienced | 6 months | 
| Headache intensity | Assessed via qualitative rating of sharp, dull, pressure, or incisional pain | 6 months |