Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2025-06-30
2025-12-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Early Scalp Block Group
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
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.
Postoperative Scalp Block Group
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.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Sakarya University
OTHER
Responsible Party
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Muhammed Halit Tekeci, MD
Anesthesiology and Reanimation Specialist, M.D.
Locations
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Sakarya University Training and Research Hospital
Sakarya, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Muhammed Halit Tekeci, Specialist
Role: primary
Havva Kocayiğit, Assoc. Prof.
Role: backup
Other Identifiers
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E-43012747-050.04-474853246
Identifier Type: -
Identifier Source: org_study_id