Postoperative Pain and Headache After Craniotomy

NCT03908944 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: 210979
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

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

Methadone

EXPERIMENTAL

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

Interventions

Methadone DRUG

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.

Methadone

Standard of Care DRUG

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing Supratentorial, Infratentorial or Skull Base Tumor resection.
• Age 18 to 75
• ASA physical status I to III

You may not qualify if:

• 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

Sponsors & Collaborators

• Steven Edelstein: lead

Study Sites (1)

Loyola Medical Center

Maywood, Illinois, 60156, United States

Location

Related Publications (10)

• 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.

  PMID: 8837797 BACKGROUND

• 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.

  PMID: 15960721 BACKGROUND

• 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.

  PMID: 15613200 BACKGROUND

• 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.

  PMID: 10667820 BACKGROUND

• 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.

  PMID: 8572094 BACKGROUND

• Vijayan N. Postoperative headache in acoustic neuroma. Headache. 1995 Feb;35(2):98-100. doi: 10.1111/j.1526-4610.1995.hed3502098.x.

  PMID: 7737870 BACKGROUND

• 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.

  PMID: 14744251 BACKGROUND

• 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.

  PMID: 2240918 BACKGROUND

• 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.

  PMID: 16890064 BACKGROUND

• 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.

  PMID: 24698296 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Methadone; Standard of Care

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Walter Jellish, MD/Ph.D

  Loyola University

  PRINCIPAL INVESTIGATOR

• Steven Edelstein, MD

  Loyola University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Study participant will be blinded
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Anesthesiology, Vice-Chairman

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: April 9, 2019
• Study Start: January 2, 2019
• Primary Completion: January 2, 2021
• Study Completion: January 2, 2022
• Last Updated: June 12, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)