Scalp Block -Craniotomi

NCT06264765 | Recruiting

• 1 other identifier: 22-12-23
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative pain after craniotomy is an important clinical problem as it can lead to hypertension and increased intracranial pressure. Multimodal analgesia methods are performed by anesthesiologists in different ways depending on the anesthetist's preference. In addition, both techniques have been shown in studies to provide intraoperative hemodynamic stabilization in addition to their effects on postoperative pain. Although there are many studies on both techniques, the number of studies comparing scalp block with infiltration technique is very limited. Therefore, postoperative use of scalp block and incisional infiltration for postoperative pain after craniotomy is recommended.

Conditions

Hemodynamic Instability

Keywords

scalp block; opioid consumption; postoperative pain

Outcome Measures

Primary Outcomes (1)

• opioid consumption

  Postoperative 30th minute, 1st, 6th, 12th, 18th. Patients' opioid consumption on the PCA will be recorded at the 24th and 24th hours.

  24 hours

Secondary Outcomes (1)

• The Numeric Rating Scale (NRS)

  24 hours

Study Arms (2)

scalp block

OTHER

Following induction of anesthesia, a scalp block will be performed before the surgery begins.

Other: scalp block

incisional infiltration

OTHER

Following induction of anesthesia, incisional infiltration will be performed before the surgery begins.

Other: Incisional infiltration

Interventions

scalp block OTHER

The scalp block will be performed by the anesthesiologist 10 minutes before the pin head holder application (PHHA). Supraorbital and supratrochlear nerves will be blocked bilaterally with 6 ml of 0.5% bupivacaine injected vertically into the skin above the eyebrow midline. Auriculotemporal nerves will be blocked bilaterally by injecting 4 ml of 0.5% bupivacaine 1.5 cm anterior to the ear at the tragus level. The needle will be inserted perpendicular to the skin and the fascia will be injected deeply and superficially while the needle is withdrawn. Postauricular branches of the greater auricular nerves will be blocked bilaterally with 2 ml of 0.5% bupivacaine injected 1 cm posterior to the ear, between the bone and skin, at the level of the tragus. The greater, lesser, and third occipital nerves run along the upper nuchal line approximately halfway between the occipital prominence and the mastoid prominence.

scalp block

Incisional infiltration OTHER

Incisional infiltration: 20 ml of 0.5% bupivacaine will be infiltrated by the surgeon into the PHHA points and surgical incision areas 10 minutes before PHHA. Two

incisional infiltration

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who underwent craniotomy under elective conditions
• ASA I-III
• years old
• GCS \>13

You may not qualify if:

• GCS \<13
• Emergency surgery
• Presence of contraindications to the LA agents used in this study
• Chronic use of opioids
• Psychiatric disorders
• Presence of infection at the injection site
• Uncontrolled intracranial hypertension
• Chronic hypertension,
• Coronary artery disease, arrhythmia,
• Coagulopathy,
• Patients who have previously undergone craniotomy

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Ferdi Gülaştı

Aydin, 09020, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• ferdi gülasştı

  Aydin Adnan Menderes University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ferdi gülaştı

CONTACT

5054929650; ferdigulasti@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Blind patients and postoperative follow-ups will not know which group the patient is in the study.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ANESTHESİOLOGİST

Model Details: randomized double blinding

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: February 20, 2024
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2026
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

TU (1)