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NCT Number: NCT07043621

When to Block? Timing of Scalp Block in Craniotomy

This study aims to evaluate the effect of scalp block timing-Group 1 will receive a pre-pinning scalp block, while Group 2 will receive a pre-emergence scalp block.-on postoperative recovery quality in patients undergoing supratentorial tumor 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).

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Key information

Conditions

Scalp Block Agnosia Craniotomy Surgery Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications QoR-40 Regional Anesthesia Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sakarya University Training and Research Hospital

Adapazarı, Sakarya, 54290, Turkey (Türkiye)

About this study

Supratentorial tumor craniotomy is a surgical procedure involving the opening of the skull to access the brain. Awakening patients after craniotomy must be performed gradually to maintain hemodynamic stability. During the procedure, injury to soft tissues and muscles can lead to somatic pain, which may cause hypertension and tachycardia, potentially increasing intracranial pressure and resulting in cerebral edema or hematoma. Therefore, effective postoperative pain management and hemodynamic stability are crucial in neurosurgical patients.

Post-craniotomy pain control methods include opioids, non-steroidal anti-inflammatory drugs (NSAIDs), local anesthetic infiltration at the incision site, and scalp block. However, prolonged opioid use is not recommended due to the risk of dependence and negative cognitive effects. Scalp block has been shown to be effective in controlling post-craniotomy pain and offers prolonged analgesia.

The Quality of Recovery-40 (QoR-40) questionnaire, developed by P.S. Myles, is a validated tool used to assess postoperative recovery. It is a five-point Likert-type scale consisting of 40 items, divided into five subscales: emotional state (9 items), physical comfort (12 items), psychological support (7 items), physical independence (5 items), and pain (7 items). Total scores range from 40 to 200, with higher scores indicating better recovery.

While the efficacy of scalp block in post-craniotomy pain control is well established, limited data exist regarding the influence of timing of block administration on recovery quality. This study aims to compare the effects of preoperative versus postoperative scalp block on recovery, using the QoR-40 questionnaire.

A total of 60 patients undergoing supratentorial tumor craniotomy at Sakarya University Training and Research Hospital will be included. Eligibility criteria include patients aged 18-80 years, classified as ASA I-III, and with a postoperative GCS of 15. Exclusion criteria include chronic preoperative use of analgesics, GCS <15, known allergy to local anesthetics or opioids used in scalp block or patient-controlled analgesia.

The primary outcome is the QoR-40 score. Secondary outcomes include intraoperative and postoperative hemodynamic parameters and postoperative pain scores measured with the Visual Analog Scale (VAS).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged between 18 and 80 years.
  • Scheduled for elective supratentorial tumor 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.

Exclusion criteria

  • 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.

Treatment and study plan

pre-pinning 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.

Other names: Pre-pinning Scalp Block Group

pre-emergence 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.

Other names: Pre-emergence Scalp Block Group

Primary outcomes

  1. Quality of Recovery Score

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

    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).

Secondary outcomes

  1. Perioperative Hemodynamic Changes

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

    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.

  2. Perioperative Hemodynamic Changes

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

    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.

  3. Intraoperative and Postoperative Opioid Consumption

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

    From induction to 24 hours postoperatively

  4. Postoperative Pain Scores

    Time frame: 10 minutes, 2 hours, 6 hours, and 24 hours postoperatively

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

Other outcomes

  1. Adverse effects

    Time frame: Postoperative 24 hours

    Any adverse effects related to anesthetic and analgesic procedures.

Sponsors and collaborators

Lead sponsor

Sakarya University

Other

Registry information

Official study title

Scalp Block Before Head Pinning or Before Emergence in Supratentorial Tumor Craniotomy: A Randomized Controlled Evaluation of Quality of Recovery and Hemodynamic Responses

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 29, 2025
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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