When to Block? Timing of Scalp Block in Craniotomy

ConditionsScalp Block Regional Anesthesia Craniotomy Surgery QoR-40

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-80

SponsorSakarya University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Early Scalp Block Group
Procedure/Surgery
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.
Late Scalp Block Group
Procedure/Surgery
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.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Early Scalp Block GroupActive comparator 1 intervention

Group B: Postoperative Scalp Block GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

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).

Time frame

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

Secondary outcomes

Perioperative Hemodynamic Changes

Heart rate will be recorded at the following time points: Baseline (before anesthesia induction) Before head pinning 1 minute after head pinning 30 minutes after surgical incision 60 minutes after surgical incision 90 minutes after surgical incision Before extubation At the 5th minute after extubation These measurements will be used to evaluate intraoperative hemodynamic stability between study groups.

Time frame

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

Perioperative Hemodynamic Changes

mean arterial pressure (MAP) will be recorded at the following time points: Baseline (before anesthesia induction) Before head pinning 1 minute after head pinning 30 minutes after surgical incision 60 minutes after surgical incision 90 minutes after surgical incision Before extubation At the 5th minute after extubation These measurements will be used to evaluate intraoperative hemodynamic stability between study groups.

Time frame

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

Intraoperative and Postoperative Opioid Consumption

From induction to 24 hours postoperatively

Time frame

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

Postoperative Pain Scores

Pain will be assessed using a 10-point Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain.

Time frame

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

Other outcomes

Adverse effects

Any adverse effects related to anesthetic and analgesic procedures.

Time frame

Postoperative 24 hours

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sakarya University

Lead sponsor

Source ClinicalTrials.gov

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