Trial Title:
Comparison of the Analgesic Effects of Scalp Nerve Block and Intravenous Ibuprofen Applications Under the Guidance of Nociception Level Index (NoL) in Patients Undergoing Elective Supratentorial Craniotomy
NCT ID:
NCT05763836
Condition:
Supratentorial Brain Tumor
Conditions: Official terms:
Brain Neoplasms
Ibuprofen
Conditions: Keywords:
supratentorial craniotomy
scalp nerve block
intravenous ibuprofen
nociception level index
opioid reducing analgesia
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Factorial Assignment
Primary purpose:
Prevention
Masking:
Double (Participant, Care Provider)
Intervention:
Intervention type:
Drug
Intervention name:
Ibuprofen 800 Mg in 8 mL INTRAVENOUS INJECTION [Caldolor]
Description:
Intravenous ibuprofen infusion
Arm group label:
Group Ibuprofen
Arm group label:
Grup Ibuprofen&Block
Intervention type:
Procedure
Intervention name:
Scalp nerve block
Description:
Scalp nerves blocked by using local anesthetics
Arm group label:
Group Block
Arm group label:
Grup Ibuprofen&Block
Summary:
Introduction: Scalp incision is a powerful nociceptive stimulus that can exacerbate rapid
changes in hemodynamic and sympathetic activity. Management of hemodynamic stability is
essential in neuro-anesthesia and can be challenging among neurosurgery
anesthesiologists. Neurosurgery operations include steps with a lot of painful stimuli
such as intubation, insertion of a head-pinning, and craniotomy. A good anesthetic
technique can improve hemodynamic responses by reducing the incidence of complications
such as intracranial hypertension, bleeding, and longer recovery time. Routine analgesic
approach in the intraoperative and postoperative period of supratentorial craniotomy
includes the routine use of paracetamol, opioids, scalp nerve block with proven
effectiveness, and intravenous ibuprofen, which gives good results by reducing opioid
doses in moderate-to-severe pain. Supratentorial craniotomy surgery, which requires tight
hemodynamic control, needs effective analgesic methods.
Trial design: It is a prospective, randomized controlled, consisting of factorial groups,
double-blind study.
Participants: This study will be carried out at Ankara University Faculty of Medicine
İbni Sina Hospital (Altındağ, Ankara, Turkey) between November 2022 and February 2023.
One hundred and two ASA I-III patients with a body mass index (BMI) below 30, aged
between 18 and 65, who will undergo elective supratentorial craniotomy due to a brain
tumor, are planned to be included in the study.
Interventions: The group in which IV ipurofen was administered was named Ibuprofen Group
(Group I), the group in which scalp nerve block was applied Block Group (Group), and the
group in which IV ibuprofen and scalp nerve block were applied together was named
Ibuprofen+Block Group (IB Group). In the premedication unit, 800 mg of ibuprofen in 100
ml of normal saline will be administered to Group I and Group IB, and 100 ml of normal
saline without ibuprofen will be administered to Group B as a 30-minute IV infusion.
After intubation, a scalp nerve block with 20 ml of 0.5% bupivacaine will be applied to
Group B and Group IB, and 20 ml of normal saline will be injected into the block sites in
Group I.
Objective: The investigators aimed to show the effect of scalp nerve block and IV
ibuprofen applications, which are routinely applied, on the optimization of the patient's
process from induction to the early postoperative period. In addition, the investigators
will examine the comparison of hemodynamic and analgesic effects of scalp nerve block and
IV ibuprofen applications under the guidance of pain monitor, and their contribution to
reducing opioid consumption, which has side effects such as postoperative
nausea/vomiting, slowing of GI motility, respiratory depression.
Outcome: The primary endpoint of the study was the differences between the groups in the
changes in the patients' nociception level (NoL) index, heart rate, and blood pressure
parameters at the time of head-pinning and the first surgical skin incision.
Randomization: Randomization of the patients into 3 groups will be carried out using the
closed envelope method.
Blinding: The patients included in the study and the practicing anesthesiologist do not
know which patient is included in which group.
Detailed description:
Scalp incision is a powerful nociceptive stimulus that can exacerbate rapid changes in
hemodynamic and sympathetic activity. Management of hemodynamic stability is essential in
neuro-anesthesia and can be challenging among neurosurgery anesthesiologists. A good
anesthetic technique can improve hemodynamic responses by reducing the incidence of
complications such as intracranial hypertension, bleeding, and longer recovery time. The
stable hemodynamic not only provide an easy-to-perform surgical field, but also prevent
serious complications such as bleeding, aneurysm rupture, and cerebral ischemia. In
patients with impaired cerebral autoregulation, even a small increase in systemic
arterial blood pressure can cause unexpected spikes in cerebral blood flow and
intracranial pressure.
Neurosurgery operations include steps with a lot of painful stimuli such as intubation,
insertion of a head-pinning, and craniotomy. In these patients where autoregulation may
be impaired, it is extremely important to monitor the pain and provide adequate analgesia
as well as providing sufficient depth of anesthesia in order to keep the hemodynamics
stable.
Craniotomy consists of the steps of such as head-pinning in order to stabilize the head,
making a skin incision, cutting the skull bone and removing the dura-mater and reaching
the brain parenchyma. This process, which ends with the dura-mater incision, which the
investigators define as the early intraoperative period, is the time period in which the
most painful stimulus is observed, and accordingly, the increase in the level of
vasoactive agents causes an increase in heart rate and blood pressure. In 86% of
patients, there is pain of somatic origin, possibly involving soft tissue and pericranial
muscles. Pain in this process is generally moderate to severe pain.
It has been reported that the pain after craniotomy is less than the pain after lumbar
laminectomy for lumbar disc herniation. However, it has been shown that moderate-to-high
pain may occur after craniotomy, especially in the first 2 hours postoperatively, and
this is more common than previously thought. Increased oxygen consumption and
catecholamine release caused by postoperative pain may predispose to intracranial
hematomas by causing brain hyperemia and increased intracranial pressure. Local
anesthetic infiltration or systemic analgesics such as non-steroidal anti-inflammatory
drugs and opioids are used for craniotomy pain palliation. If the patient is conscious
and feels pain after craniotomy, effective analgesia should be provided.
Routine analgesic approach in the intraoperative and postoperative period of
supratentorial craniotomy includes the routine use of paracetamol, opioids, scalp nerve
block with proven effectiveness, and intravenous (IV) ibuprofen, which gives good results
by reducing opioid doses in moderate-to-severe pain. There are studies comparing drugs
such as opioids, non-steroidal anti-inflammatory drugs (NSAIDs), ketamine, IV lidocaine,
gabapentin in the prevention of the sympathetic response that occurs when entering the
spiked cap and in the prevention of post-craniotomy pain and among these, scalp nerve
block is accepted as the most effective analgesic approach.
Supratentorial craniotomy surgery, which requires tight hemodynamic control, needs
effective analgesic methods. In this study, the investigators aimed to show the effect of
scalp nerve block and IV ibuprofen applications, which are routinely applied, on the
optimization of the patient's process from induction to the early postoperative period.
In addition, the investigators will examine the comparison of hemodynamic and analgesic
effects of scalp nerve block and IV ibuprofen applications under the guidance of pain
monitor, and their contribution to reducing opioid consumption, which has side effects
such as postoperative nausea/vomiting, slowing of GI motility, respiratory depression.
It is a prospective, randomized controlled, double-blind study. Randomization of the
patients into 3 groups will be carried out using the closed envelope method. The group in
which IV ipurofen was administered was named Ibuprofen Group (Group I), the group in
which scalp nerve block was applied Block Group (Group), and the group in which IV
ibuprofen and scalp nerve block were applied together was named Ibuprofen+Block Group (IB
Group). The patients included in the study and the practicing anesthesiologist do not
know which patient is included in which group.
Fentanyl (1-2 μg/kg) and propofol (2-3 mg/kg) will be used for anesthesia induction.
Rocuronium (0.6 mg/kg) will be used as a muscle relaxant. Anesthesia maintenance will be
provided with propofol and remifentanil infusion, keeping the bispectral index (BISTM)
between 40-60 and the nociception level (NoL) index (PMD-200TM) between 10-25. The
neuromuscular block depths of the patients will be monitored with train-of-four (TOF). As
components of multimodal analgesia, 1 g paracetamol and 1.5 g magnesium sulfate will be
administered as IV infusion to all patients after induction. Propofol and remifentanil
infusions will be stopped after the end of the surgical procedure. Patients who have the
appropriate level of consciousness and can perform simple commands will be extubated
after the BIS value is above 80 and the TOF percentage is above 90.
In the premedication unit, 800 mg of ibuprofen in 100 ml of normal saline will be
administered to Group I and Group IB, and 100 ml of normal saline without ibuprofen will
be administered to Group B as a 30-minute IV infusion. After the infusion is over, the
patients will be taken to the operating table. After the monitoring is completed,
induction will be made and intubated.
After intubation, a scalp nerve block with 20 ml of 0.5% bupivacaine will be applied to
Group B and Group IB, and 20 ml of normal saline will be injected into the block sites in
Group I. Head stabilization will be achieved with a spiked head 5 minutes after the block
application is completed. Normal saline solutions containing or not containing ibuprofen
and the injectors used in the block will be prepared by the anesthesia technicians and
the practicing anesthetist will be kept unaware of the content of the applied substance.
If the NoL value rises above 25 at all stages of the surgical process, an IV bolus of 0.5
mcg/kg remifentanil will be administered as a rescue analgesic.
Demographic characteristics such as the patient's name, surname, gender, age, weight,
co-morbidities, American Society of Anesthesiologists (ASA) score will be recorded in the
data collection form. In the intraoperative process, heart rate (HR), systolic blood
pressure (SBP), diastolic blood pressure (DBP), NoL value, BIS value parameters will be
recorded before intubation, after intubation, before head-pinning, after head-pinning,
before surgical incision, after surgical incision, before craniotomy, after craniotomy,
before dura mater incision, and after dura mater incision.
In the intraoperative process, the times when rescue analgesics are needed will be
recorded.
SPSS 11.5 program will be used in the analysis of the data. Mean±standard deviation and
median (minimum-maximum) will be used for quantitative variables, and the number of
patients (percentage) for qualitative variables. The Kruskal Wallis H test will be used
to determine whether there is a difference between the categories of a qualitative
variable with more than two categories in terms of quantitative variables, since the
assumptions of normal distribution are not provided. Chi-square and Fisher exact tests
will be used when the relationship between two qualitative variables is desired. To look
at the before-after differences of the same measurement, if normal distribution
assumptions are provided, the Paired-t test will be used, otherwise the Wilcoxon Sign
test will be used. Statistical significance level will be taken as 0.05.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Undergoing elective suptatentorial craniotomy surgery
- Body Mass Index (BMI) below 30
- ASA I-III patient
Exclusion Criteria:
- Patients with a history of allergic reaction to the drugs to be used in the study
- Patients with heart, kidney and liver failure
- Patients who refused to participate in the study
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Ankara University Fakulty of Medicine
Address:
City:
Ankara
Zip:
06100
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Ahmet C Ceran
Phone:
+905310805423
Email:
ahmetcemceran38@gmail.com
Start date:
November 1, 2022
Completion date:
March 5, 2023
Lead sponsor:
Agency:
Ankara University
Agency class:
Other
Source:
Ankara University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05763836
