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

NCT05763836 | Unknown Phase 4

• 1 other identifier: AU-AUFM-MECO.CERAN.ERKOC-23001
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Supratentorial Brain Tumor

Keywords

supratentorial craniotomy; scalp nerve block; intravenous ibuprofen; nociception level index; opioid reducing analgesia

Outcome Measures

Primary Outcomes (1)

• Nociception level (NoL) index

  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 Outcomes (5)

• Heart rate

  Heart rate measurements will be recorded during surgery.

• Opioid consumption

  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

  1st, 2nd and 3rd hours after surgery

• Systolic blood pressure

  Systolic blood pressure measurements will be recorded during surgery.

• Dystolic blood pressure

  Dystolic blood pressure measurements will be recorded during surgery.

Study Arms (3)

Group Block

ACTIVE COMPARATOR

Scalp nerve block applied group

Procedure: Scalp nerve block

Group Ibuprofen

EXPERIMENTAL

Intravenous ibuprofen applied group

Drug: Ibuprofen 800 Mg in 8 mL INTRAVENOUS INJECTION [Caldolor]

Grup Ibuprofen&Block

EXPERIMENTAL

Both intravenous ibuprofen and scalp nerve block applied group

Drug: Ibuprofen 800 Mg in 8 mL INTRAVENOUS INJECTION [Caldolor]; Procedure: Scalp nerve block

Interventions

Ibuprofen 800 Mg in 8 mL INTRAVENOUS INJECTION [Caldolor] DRUG

Intravenous ibuprofen infusion

Group Ibuprofen; Grup Ibuprofen&Block

Scalp nerve block PROCEDURE

Scalp nerves blocked by using local anesthetics

Group Block; Grup Ibuprofen&Block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing elective suptatentorial craniotomy surgery
• Body Mass Index (BMI) below 30
• ASA I-III patient

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University Fakulty of Medicine

Ankara, Altındağ, 06100, Turkey (Türkiye)

RECRUITING

Related Publications (18)

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MeSH Terms

Interventions

Ibuprofen; Injections, Intravenous

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Injections

Study Officials

• Başak Ceyda Meço

  Ankara University

  STUDY DIRECTOR

Central Study Contacts

Ahmet C Ceran

CONTACT

+905310805423; ahmetcemceran38@gmail.com

Başak Ceyda Meço

CONTACT

+905324179911; basakceyda@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: March 10, 2023
• Study Start: November 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 5, 2023
• Last Updated: March 10, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: For 1 year from the date of publication
• Access Criteria: Academic institutions and individuals who have reached via e-mail

Locations

TU (1)