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Tumor, BrainPhase 1Scalp blockNCT03177252

Scalp Block: Hemodynamic Stability and Patient Comfort In Craniotomy Patients

A Phase 1 study testing Lidocaine, Sodium chloride and Bupivacaine in people with Tumor, Brain and Anesthesia, Local, run by Washington University School of Medicine.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tumor, Brain, Anesthesia, Local
What is being tested?
Lidocaine, Sodium chloride and Bupivacaine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
1 Oct 2020to 30 Sep 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

About this study

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.

Read the detailed description

Avoidance of hemodynamic fluctuations in the heart rate and or the blood pressure perioperatively, rapid postoperative recovery, and adequate postoperative pain relief are some of the important goals of neurosurgical anesthesia. Scalp block in association with general anesthesia is used to achieve these goals. Previous studies have been published related to the effect of scalp block on the perioperative outcomes on the craniotomy patients. The results reported so far are controversial and one cannot at this point define a positive effect for post-operative pain relief. This disparity in results may be the consequences of the size of the patient population. However scalp block is an accepted practice in the craniotomy patients. The investigators believe this is the first study which assesses the effectiveness of scalp block for asleep craniotomy with the largest sample size study so far conducted in the literature related to this topic. The aim of this study is to assess the effectiveness of scalp block for the perioperative comfort of the craniotomy patients undergoing resection for supratentorial tumors.

After the consent for the participation and enrollment in the study is done, patients will be randomized to two groups, a study group will receive a scalp block with a mixture of 2% lidocaine and 0.5% bupivacaine while the control group will receive the scalp block with saline. Intraoperatively, all patients will be preoxygenated, fentanyl (1-2mcg/kg) will be given and anesthesia will be induced with propofol (1-2mg/kg) and lidocaine (1-1.5mg/kg). Tracheal intubation will be facilitated by using either rocuronium (0.6 mg/kg) or succinylcholine (1-1.5mg/kg) intravenously. The lungs will be ventilated with a fresh gas flow of oxygen for 2 minutes before tracheal intubation with cuffed oral endotracheal tube. Anesthesia will be maintained with inhalational anesthetic Isoflurane, Sevoflurane or Desflurane (0.8-1 MAC) and fentanyl infusion (1-2mcg/kg) with the dose adjusted according to the patient's hemodynamics. Bilateral BIS or EEG to maintain an adequate level of depth of anesthesia will be used whenever feasible. After intubation, a scalp block will be performed. The randomization of the scalp block syringes will be provided by the pharmacy and neither the scalp block performer nor the attending will be aware of the syringe content. To standardize the block, a pain specialist is involved. Response to the pinning will be assessed using the hemodynamic parameters and rescue analgesics (fentanyl bolus 50 - 100 mcg) and/or propofol bolus 50 - 100 mg will be given as a bolus if significant response is noted. Significant response being a 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 just before pinning. Similarly, response to the surgical incision will be noted and rescue analgesics will be given if needed. Intraoperative propofol requirement and opioid requirements will be recorded. The post-operative orders for pain control will be standardized for all the patients.

Being tested
Lidocaine, Sodium chloride, Bupivacaine
Medical subject headings
Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LidocaineDrug

    -2% lidocaine will be given

  • Sodium chlorideDrug

    Also called Saline, Normal Saline

    -Normal saline will be given

  • BupivacaineDrug

    -0.5% bupivacaine will be given

Study groups in NCT03177252
Study groupRoleWhat they receive
Scalp block with lidocaine and bupivacaineExperimental* 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.
Receives: Drug: Lidocaine; Drug: Bupivacaine
Scalp block with salinePlacebo 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.
Receives: Drug: Sodium chloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Up to 48 hours

  2. 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.

    Measured: Up to 48 hours

Secondary outcomes (1)
  1. Cost-effectiveness of scalp block

    Scalp block for the craniotomy

    1. lowers overall administration of opioids, which will decrease the side effects of opioids
    2. improve the immediate postoperative pain which may decrease the occurrence of chronic postoperative pain and
    3. may result in the early discharge from the hospital contributing to shorter hospital stay reducing the financial burden for both the patient and the hospital.

    Measured: Up to 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2017
  2. Study start1 Oct 2020 (estimated)
  3. Primary completion30 Sep 2021 (estimated)
  4. Study completion30 Sep 2021 (estimated)

Why it stopped: Investigator decided not to go forward with the trial.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03177252
Sponsor's protocol ID
201701037
Acronym
Scalp block
Status last verified
Oct 2020
First submitted
8 May 2017
Last updated
22 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lidocaine, Sodium chloride and Bupivacaine in people with Tumor, Brain and Anesthesia, Local, run by Washington University School of Medicine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall perioperative comfort of the patient as measured by hemodynamic fluctuations (time frame: Up to 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.

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