Effects of Scalp Nerve Block on Postoperative Pain, Hemodynamics and Surgical Stress Response in Craniotomy Surgery

NCT06748547 | Not Yet Recruiting

• 1 other identifier: UERH-AR-ZT-10
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The hypothesis of this study is that preincisional scalp nerve block will reduce postoperative opioid use and surgical stress response compared to postincisional scalp nerve block in craniotomy surgery with general anesthesia.

Conditions

Analgesia; Post Operative Pain

Keywords

scalp nerve block,Craniotomy,postoperative pain

Outcome Measures

Primary Outcomes (1)

• hemodynamic parameters

  mean arterial pressure (mmHg)

  24 hours

Secondary Outcomes (1)

• amount of opioid received during surgery

  24 hours

Study Arms (2)

1

Group pre-incisional: received 0.5% 20 ml bupivacaine preincisional before the nail head was placed

Procedure: scalp nerve block

2

Group post-incisional: received 0.5% 20 ml bupivacaine postcisional after the skin incision was closed

Procedure: scalp nerve block

Interventions

scalp nerve block PROCEDURE

scalp nerve block is performed bilaterally by an anesthesiologist after induction of anesthesia and 5 minutes before head immobilization, according to the technique described by Pinosky et al. Prepare a syringe (20 mL) for scalp blocks. It is performed using 0.35% bupivacaine and 5 mcg epinephrine (1:2,000,000) using a 23-gauge needle inserted at a 45° angle to the skin and penetrating deeply into the outer edge of the scalp.

1; 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who will undergo cranitomy with general anesthesia

You may qualify if:

• Age range 18-65
• ASA 1-3 score

You may not qualify if:

• Chronic hypertension
• Arrhythmia
• body mass index (BMI) over 40 kg/m2
• Bleeding diathesis
• Allergy
• Serious cardiovascular, pulmonary, renal and hepatic disease
• Local infection at the injection site
• Alcohol and substance abuse
• Neurological sequelae, mental retardation
• GCS under 15
• Patients admitted to the intensive care unit as intubated
• Pregnancy
• Those with a history of chronic pain
• Scalp infection
• Use of vozoactive drugs

Sponsors & Collaborators

• Umraniye Education and Research Hospital: lead

Study Sites (1)

Umraniye Education and Research Hospital

Istanbul, Umraniye, 34734, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Anesthesia and reanimation

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: December 27, 2024
• Study Start: November 30, 2025
• Primary Completion: March 28, 2026
• Study Completion: May 1, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)