WithdrawnPhase 2

Postoperative Pain and Headache After Craniotomy

Stopped: PI- Dr. Jellish passed away. The study was terminated with the IRB

United States0Started 2019-01-02

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Post craniotomy pain

Timeframe: 6 months

Headache intensity

Timeframe: 6 months

Trial details

NCT IDNCT03908944

SponsorSteven Edelstein

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-01-02

View on ClinicalTrials.gov More Postoperative Pain trials