Postoperative Pain and Headache After Craniotomy

NCT ID: NCT03908944

Last Updated: 2020-06-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-02
• Study Completion Date: 2022-01-02

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Methadone

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Steven Edelstein

OTHER

Sponsor Role: lead

Responsible Party

Steven Edelstein

Anesthesiology, Vice-Chairman

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Walter Jellish, MD/Ph.D

Role: PRINCIPAL_INVESTIGATOR

Loyola University

Steven Edelstein, MD

Role: STUDY_DIRECTOR

Loyola University

Locations

Loyola Medical Center

Maywood, Illinois, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 8837797 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15960721 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15613200 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10667820 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8572094 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 7737870 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14744251 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 2240918 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16890064 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24698296 (View on PubMed)

Other Identifiers

210979

Identifier Type: -

Identifier Source: org_study_id