When to Block? Timing of Scalp Block in Craniotomy

Sakarya University

Status: Not yet enrolling

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

Treatments: Procedure: Early Scalp Block Group; Procedure: Late Scalp Block Group

Study type: Interventional

Funder types: Other

Identifiers

NCT07043621

E-43012747-050.04-474853246

Details and patient eligibility

About

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).

Full 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).

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Early Scalp Block Group

Active Comparator group

Description:

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

Treatment:

Procedure: Early Scalp Block Group

Postoperative Scalp Block Group

Active Comparator group

Description:

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.

Treatment:

Procedure: Late Scalp Block Group