Scalp Block: Hemodynamic Stability and Patient Comfort In Craniotomy Patients
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/28/2019 |
| Start Date: | June 1, 2019 |
| End Date: | February 28, 2020 |
| Contact: | Umeshkumar Athiraman, M.D. |
| Email: | uathira@wustl.edu |
| Phone: | 314-362-2330 |
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.
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.
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.
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.
Inclusion Criteria:
->18years of age undergoing elective craniotomy for supratentorial tumors
Exclusion Criteria:
- 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.
We found this trial at
1
site
Saint Louis, Missouri 63110
Principal Investigator: Umeshkumar Athiraman, M.D.
Phone: 314-362-2330
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