NCT07043621

When to Block? Timing of Scalp Block in Craniotomy

Scalp Block Before Incision or Before Emergence in Craniotomy: A Randomized Controlled Evaluation of Effectiveness and Recovery Quality Via QoR-40

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Sakarya University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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 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).

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Early Scalp Block Group	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.
PROCEDURE	Late Scalp Block Group	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.

Timeline

• Start date: 2025-06-01
• Primary completion: 2025-11-01
• Completion: 2025-12-01
• First posted: 2025-06-29
• Last updated: 2025-06-29

Locations

1 site across 1 country: Turkey (Türkiye)