Scalp Block: Hemodynamic Stability and Patient Comfort In Craniotomy Patients

NCT03177252 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: 201701037
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Making sure the heart rate and or the blood pressure \[called hemodynamic instability\] during surgery is stable, setting up for a rapid postoperative recovery, and ensuring that patients have adequate pain relief are some of the important goals of neurosurgical anesthesia. Scalp block anesthesia \[injection of a numbing agent into the area of the scalp where the incision will be\] together with general anesthesia is used to achieve these goals. There has been some research on whether or not scalp block improves patient recovery and pain management, but the studies have not be large enough to say for certain. This is true even though scalp block is used with almost every patient that is having brain surgery. The investigators propose to determine if scalp block in combination with asleep anesthesia is better than asleep anesthesia alone in patients who are having brain surgery for tumors in the cerebral area of the brain.

Conditions

Tumor, Brain; Anesthesia, Local

Outcome Measures

Primary Outcomes (2)

• Overall perioperative comfort of the patient as measured by hemodynamic fluctuations

  Hemodynamic fluctuations during pinning of the head with a Mayfield head-holder and skin incision which represents the most extreme painful stimulation for the entire surgery (significant response being rise in the patient's heart rate and/or the blood pressure more than 20% from the patient's baseline heart rate and/or the blood pressure prior pinning)

  Up to 48 hours

• Overall perioperative comfort as measured by opioid requirements

  Overall perioperative opioid requirements until the next morning of the surgery as an overall evaluation of the patient's comfort.

  Up to 48 hours

Secondary Outcomes (1)

• Cost-effectiveness of scalp block

  Up to 48 hours

Study Arms (2)

Scalp block with lidocaine and bupivacaine

EXPERIMENTAL

* Scalp block with a mixture of 2% lidocaine and 0.5% bupivacaine * Once the surgery is completed, patients will be awaken and extubated following a basic neurological exam. If the extubation is delayed or if the patient is taken to ICU intubated, those patients will be excluded from the study.

Drug: Lidocaine; Drug: Bupivacaine

Scalp block with saline

PLACEBO COMPARATOR

* Scalp block with saline * Once the surgery is completed, patients will be awaken and extubated following a basic neurological exam. If the extubation is delayed or if the patient is taken to ICU intubated, those patients will be excluded from the study.

Drug: Sodium chloride

Interventions

Lidocaine DRUG

-2% lidocaine will be given

Scalp block with lidocaine and bupivacaine

Sodium chloride DRUG

-Normal saline will be given

Also known as: Saline, Normal Saline

Scalp block with saline

Bupivacaine DRUG

-0.5% bupivacaine will be given

Scalp block with lidocaine and bupivacaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18years of age undergoing elective craniotomy for supratentorial tumors

You may not qualify if:

• Age group \< 18
• Emergency craniotomies
• Infratentorial tumors.
• Patients who need intraoperative evoked potential monitoring which precludes the scalp block.
• Patients with known cranial defects.
• Patients who are on medications for chronic pain.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Lidocaine; Sodium Chloride; Saline Solution; Bupivacaine

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Umeshkumar Athiraman, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: June 6, 2017
• Study Start: October 1, 2020
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share