This randomized phase I trial studies how well scalp block works in controlling vital signs and pain in patients with brain tumors undergoing surgery. Administering a local anesthetic, a mixture of two medications called lidocaine and bupivacaine, to numb the scalp may provide better control of heart rate, blood pressure, and pain relief during and after the surgery.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03177252.
PRIMARY OBJECTIVES:
I. To assess the effectiveness of scalp block in attenuating the perioperative hemodynamic fluctuations.
II. To assess the effectiveness of the scalp block for the postoperative pain by assessing the post-operative opioid requirements.
III. To evaluate the hospital discharge time after the craniotomy procedure and assess the cost-effectiveness of the scalp block.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive a scalp block with a mixture of lidocaine and bupivacaine hydrochloride via injection into surgical incision site prior to craniotomy.
GROUP II: Patients receive a saline placebo via injection into surgical incision site prior to craniotomy.
Trial PhasePhase I
Trial Typesupportive care
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorUmesshkumar Athiramam