- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03908944
Postoperative Pain and Headache After Craniotomy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Illinois
-
Maywood, Illinois, United States, 60156
- Loyola Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard of Care
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.
|
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.
|
Experimental: Methadone
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post craniotomy pain
Time Frame: 6 months
|
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
Time Frame: 6 months
|
Assessed via qualitative rating of sharp, dull, pressure, or incisional pain
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Walter Jellish, MD/Ph.D, Loyola University
- Study Director: Steven Edelstein, MD, Loyola University
Publications and helpful links
General Publications
- Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990 Dec 15;113(12):941-8. doi: 10.7326/0003-4819-113-12-941.
- Hawthorne G, Sansoni J, Hayes L, Marosszeky N, Sansoni E. Measuring patient satisfaction with health care treatment using the Short Assessment of Patient Satisfaction measure delivered superior and robust satisfaction estimates. J Clin Epidemiol. 2014 May;67(5):527-37. doi: 10.1016/j.jclinepi.2013.12.010.
- de Gray LC, Matta BF. Acute and chronic pain following craniotomy: a review. Anaesthesia. 2005 Jul;60(7):693-704. doi: 10.1111/j.1365-2044.2005.03997.x.
- De Benedittis G, Lorenzetti A, Migliore M, Spagnoli D, Tiberio F, Villani RM. Postoperative pain in neurosurgery: a pilot study in brain surgery. Neurosurgery. 1996 Mar;38(3):466-9; discussion 469-70. doi: 10.1097/00006123-199603000-00008.
- Koperer H, Deinsberger W, Jodicke A, Boker DK. Postoperative headache after the lateral suboccipital approach: craniotomy versus craniectomy. Minim Invasive Neurosurg. 1999 Dec;42(4):175-8. doi: 10.1055/s-2008-1053393.
- Mosek AC, Dodick DW, Ebersold MJ, Swanson JW. Headache after resection of acoustic neuroma. Headache. 1999 Feb;39(2):89-94. doi: 10.1046/j.1526-4610.1999.3902089.x.
- Pedrosa CA, Ahern DK, McKenna MJ, Ojemann RG, Acquadro MA. Determinants and impact of headache after acoustic neuroma surgery. Am J Otol. 1994 Nov;15(6):793-7.
- Vijayan N. Postoperative headache in acoustic neuroma. Headache. 1995 Feb;35(2):98-100. doi: 10.1111/j.1526-4610.1995.hed3502098.x.
- Lai J, Porreca F, Hunter JC, Gold MS. Voltage-gated sodium channels and hyperalgesia. Annu Rev Pharmacol Toxicol. 2004;44:371-97. doi: 10.1146/annurev.pharmtox.44.101802.121627.
- Jellish WS, Leonetti JP, Sawicki K, Anderson D, Origitano TC. Morphine/ondansetron PCA for postoperative pain, nausea, and vomiting after skull base surgery. Otolaryngol Head Neck Surg. 2006 Aug;135(2):175-81. doi: 10.1016/j.otohns.2006.02.027.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Headache
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Opioid
- Narcotics
- Respiratory System Agents
- Antitussive Agents
- Methadone
Other Study ID Numbers
- 210979
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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