search
Back to results

Postoperative Pain and Headache After Craniotomy

Primary Purpose

Postoperative Pain

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Methadone
Standard of Care
Sponsored by
Steven Edelstein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Postoperative Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Loyola Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of Care

Methadone

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
Headache intensity
Assessed via qualitative rating of sharp, dull, pressure, or incisional pain

Secondary Outcome Measures

Full Information

First Posted
March 29, 2019
Last Updated
June 10, 2020
Sponsor
Steven Edelstein
search

1. Study Identification

Unique Protocol Identification Number
NCT03908944
Brief Title
Postoperative Pain and Headache After Craniotomy
Official Title
Postoperative Pain and Headache After Craniotomy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Withdrawn
Why Stopped
PI- Dr. Jellish passed away. The study was terminated with the IRB
Study Start Date
January 2, 2019 (Actual)
Primary Completion Date
January 2, 2021 (Anticipated)
Study Completion Date
January 2, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Steven Edelstein

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Study participant will be blinded
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Methadone
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Methadone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Standard of Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Post craniotomy pain
Description
Assessed via a Verbal Analog Scale from 0-10 with 0 being no pain and 10 being the worst pain ever experienced
Time Frame
6 months
Title
Headache intensity
Description
Assessed via qualitative rating of sharp, dull, pressure, or incisional pain
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Jellish, MD/Ph.D
Organizational Affiliation
Loyola University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steven Edelstein, MD
Organizational Affiliation
Loyola University
Official's Role
Study Director
Facility Information:
Facility Name
Loyola Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60156
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share individual Data.
Citations:
PubMed Identifier
8837797
Citation
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.
Results Reference
background
PubMed Identifier
15960721
Citation
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.
Results Reference
background
PubMed Identifier
15613200
Citation
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.
Results Reference
background
PubMed Identifier
10667820
Citation
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.
Results Reference
background
PubMed Identifier
8572094
Citation
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.
Results Reference
background
PubMed Identifier
7737870
Citation
Vijayan N. Postoperative headache in acoustic neuroma. Headache. 1995 Feb;35(2):98-100. doi: 10.1111/j.1526-4610.1995.hed3502098.x.
Results Reference
background
PubMed Identifier
14744251
Citation
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.
Results Reference
background
PubMed Identifier
2240918
Citation
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.
Results Reference
background
PubMed Identifier
16890064
Citation
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.
Results Reference
background
PubMed Identifier
24698296
Citation
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.
Results Reference
background

Learn more about this trial

Postoperative Pain and Headache After Craniotomy

We'll reach out to this number within 24 hrs