When to Block? Timing of Scalp Block in Craniotomy

NCT07043621 | Not Yet Recruiting

• 1 other identifier: E-43012747-050.04-474853246
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effect of scalp block timing-whether administered preoperatively or postoperatively-on postoperative recovery quality in patients undergoing craniotomy. The recovery quality will be assessed using the validated Quality of Recovery-40 (QoR-40) questionnaire. A total of 60 patients, aged 18-80 years, classified as ASA I-III and with a Glasgow Coma Scale (GCS) score of 15 upon admission to the recovery unit, will be enrolled. The primary outcome is the QoR-40 score. Secondary outcomes include hemodynamic changes and pain intensity measured by the Visual Analog Scale (VAS).

Conditions

Scalp Block; Regional Anesthesia; Craniotomy Surgery; QoR-40

Keywords

Scalp Block; Craniotomy surgery; analgesia; postoperative pain

Outcome Measures

Primary Outcomes (1)

• Quality of Recovery Score

  Patient recovery will be assessed using the validated Turkish version of the QoR-40 (Quality of Recovery-40) questionnaire, a 40-item Likert-type scale covering five domains: emotional state, physical comfort, psychological support, physical independence, and pain. The total score ranges from 40 (poor recovery) to 200 (excellent recovery).

  The observation period extended from the beginning of surgery until 24 hours postoperatively.

Secondary Outcomes (4)

• Perioperative Hemodynamic Changes

  Intraoperative (Hemodynamic parameters were monitored from the beginning to the end of surgery.)

• Perioperative Hemodynamic Changes

  Intraoperative (Hemodynamic parameters were monitored from the beginning to the end of surgery.)

• Intraoperative and Postoperative Opioid Consumption

  Total opioid consumption will be recorded intraoperatively and within the first 24 hours postoperatively.

• Postoperative Pain Scores

  10 minutes, 2 hours, 6 hours, and 24 hours postoperatively

Other Outcomes (1)

• Adverse effects

  Postoperative 24 hours

Study Arms (2)

Early Scalp Block Group

ACTIVE COMPARATOR

Patients in this group will receive a scalp block with 0.25% bupivacaine (20 mL) administered under ultrasound guidance after the induction of general anesthesia but prior to head pinning

Procedure: Early Scalp Block Group

Postoperative Scalp Block Group

ACTIVE COMPARATOR

Patients in this group will receive a scalp block with 0.25% bupivacaine (20 mL) administered under ultrasound guidance at the end of surgery, before emergence from anesthesia.

Procedure: Late Scalp Block Group

Interventions

Early Scalp Block Group PROCEDURE

Following induction of general anesthesia and prior to head pinning (Mayfield clamp placement), a scalp block was performed under aseptic conditions using 20 mL of 0.25% bupivacaine. The block targeted six sensory nerves that innervate the scalp: Supraorbital nerve, Supratrochlear nerve, Auriculotemporal nerve ,Zygomaticotemporal nerve, Greater occipital nerve, Lesser occipital nerve. Each nerve was infiltrated subcutaneously at its anatomical location using a 25-gauge needle, with the total volume distributed evenly or proportionally across the injection sites.

Also known as: Pre-pinning Scalp Block Group

Early Scalp Block Group

Late Scalp Block Group PROCEDURE

In the pre-emergence group, the scalp block was performed at the end of surgery but before emergence from general anesthesia, while the patient was still under deep anesthesia. Under strict aseptic conditions, 20 mL of 0.25% bupivacaine was administered to block the following six sensory nerves innervating the scalp: Supraorbital nerve, Supratrochlear nerve, Auriculotemporal nerve, Zygomaticotemporal nerve, Greater occipital nerve, Lesser occipital nerve. The local anesthetic was injected subcutaneously at the anatomical landmarks of each nerve using a 25-gauge needle. The total volume was distributed evenly or proportionally depending on the area. No additional surgical stimulation occurred after the block, and extubation followed routine emergence from anesthesia.

Also known as: Pre-emergence Scalp Block Group

Postoperative Scalp Block Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged between 18 and 80 years.
• Scheduled for craniotomy under general anesthesia.
• ASA physical status classification I to III.
• Glasgow Coma Scale (GCS) score of 15 at the time of emergence from anesthesia.
• Provide informed consent to participate in the study.

You may not qualify if:

• Chronic use of analgesic medications prior to surgery.
• Glasgow Coma Scale (GCS) score below 15 postoperatively.
• Allergy or hypersensitivity to local anesthetics or opioids used in the study.
• Contraindications for scalp block or patient-controlled analgesia.
• Patients with severe hepatic, renal, or cardiac dysfunction.
• Patients unable to comprehend or complete the QoR-40 questionnaire.

Sponsors & Collaborators

• Sakarya University: lead

Study Sites (1)

Sakarya University Training and Research Hospital

Sakarya, 54290, 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

Central Study Contacts

Muhammed halit TEKECİ

CONTACT

+905389334248; halittekeci@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: A blinded investigator will monitor intraoperative hemodynamics, evaluate opioid/analgesic use, and assess postoperative recovery using the QoR-40 questionnaire.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology and Reanimation Specialist, M.D.

Model Details: A total of 60 patients undergoing elective craniotomy will be randomly assigned to one of two parallel groups (n=30 per group). Group 1 will receive a preoperative scalp block, while Group 2 will receive a postoperative scalp block. A blinded investigator will monitor intraoperative hemodynamic parameters and assess both intraoperative and postoperative opioid and analgesic consumption. Postoperatively, all patients will complete the validated Quality of Recovery-40 (QoR-40) questionnaire to evaluate recovery outcomes. The study aims to compare the effect of scalp block timing on postoperative recovery and analgesic requirements.

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: June 29, 2025
• Study Start: June 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 29, 2025

Record last verified: 2025-06

Locations

TU (1)