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

February 28, 2023 updated by: Ahmet Cem Ceran, Ankara University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

102

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
    • Altındağ
      • Ankara, Altındağ, Turkey, 06100
        • Recruiting
        • Ankara University Fakulty of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group Block
Scalp nerve block applied group
Procedure: Scalp nerve block
Scalp nerves blocked by using local anesthetics
Experimental: Group Ibuprofen
Intravenous ibuprofen applied group
Drug: Ibuprofen 800 Mg in 8 mL INTRAVENOUS INJECTION [Caldolor]
Intravenous ibuprofen infusion
Experimental: Grup Ibuprofen&Block
Both intravenous ibuprofen and scalp nerve block applied group
Procedure: Scalp nerve block
Scalp nerves blocked by using local anesthetics
Drug: Ibuprofen 800 Mg in 8 mL INTRAVENOUS INJECTION [Caldolor]
Intravenous ibuprofen infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nociception level (NoL) index
Time Frame: From the beginning of the operation until the 3rd hour after the operation
In this study, the difference between the groups in the change of NoL values due to the procedures applied in supratentorial craniotomy surgery will be evaluated. NoL values range between 0 and 100. Values above 25 indicate that the patient has pain, and the value increases as the pain increases.
From the beginning of the operation until the 3rd hour after the operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate
Time Frame: Heart rate measurements will be recorded during surgery.
In this study, the difference between the groups in the change of heart rate due to the procedures applied in supratentorial craniotomy surgery will be evaluated. It will be evaluated as beat per minute.
Heart rate measurements will be recorded during surgery.
Opioid consumption
Time Frame: After the induction of anesthesia, opioid infusion will be started and continued until the operation is completed and the maintenance of anesthesia is terminated. At the end of the surgery, the total amount of opioid consumed will be recorded.
In the study, the amount of opioid consumed during surgery between groups will be compared. The amounts of remifentanil used as an opioid will be compared. The unit will be mcg.
After the induction of anesthesia, opioid infusion will be started and continued until the operation is completed and the maintenance of anesthesia is terminated. At the end of the surgery, the total amount of opioid consumed will be recorded.
Visual Analog Scale
Time Frame: 1st, 2nd and 3rd hours after surgery
Patients will be asked to rate their pain status on a scale of 1 to 10 at 1, 2, and 3 hours after the end of surgery. Higher values indicate more pain.
1st, 2nd and 3rd hours after surgery
Systolic blood pressure
Time Frame: Systolic blood pressure measurements will be recorded during surgery.
In this study, the difference between the groups in the change of systolic blood pressure due to the procedures applied in supratentorial craniotomy surgery will be evaluated. The unit will be mmHg.
Systolic blood pressure measurements will be recorded during surgery.
Dystolic blood pressure
Time Frame: Dystolic blood pressure measurements will be recorded during surgery.
In this study, the difference between the groups in the change of dystolic blood pressure due to the procedures applied in supratentorial craniotomy surgery will be evaluated. The unit will be mmHg.
Dystolic blood pressure measurements will be recorded during surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara University

Investigators

  • Study Director: Başak Ceyda Meço, Ankara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

March 5, 2023

Study Registration Dates

First Submitted

February 8, 2023

First Submitted That Met QC Criteria

February 28, 2023

First Posted (Estimate)

March 10, 2023

Study Record Updates

Last Update Posted (Estimate)

March 10, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AU-AUFM-MECO.CERAN.ERKOC-23001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data collected to reach outcomes will be shared.

IPD Sharing Time Frame

For 1 year from the date of publication

IPD Sharing Access Criteria

Academic institutions and individuals who have reached via e-mail

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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