Scalp BlockNCT07043621
When to Block? Timing of Scalp Block in Craniotomy
A study testing pre-pinning group and pre-emergence Group in people with Scalp Block and Regional Anesthesia, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Scalp Block, Regional Anesthesia, Craniotomy Surgery
- What is being tested?
- pre-pinning group and pre-emergence Group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 27 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sakarya University Training and Research Hospital
Adapazarı, Sakarya, 54290
About this study
Official title: Scalp Block Before Head Pinning or Before Emergence in Supratentorial Tumor Craniotomy: A Randomized Controlled Evaluation of Quality of Recovery and Hemodynamic Responses
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).
Read the detailed description
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).
- Conditions
- Scalp Block, Regional Anesthesia, Craniotomy Surgery, QoR-40
- Being tested
- pre-pinning group, pre-emergence Group
- Keywords
- Scalp Block, Craniotomy surgery, analgesia, postoperative pain
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pre-pinning groupProcedure or surgery
Also called Pre-pinning 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.
pre-emergence GroupProcedure or surgery
Also called Pre-emergence 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.
| Study group | Role | What they receive |
|---|---|---|
| pre-pinning group | Active comparator | Patients in this group will receive a scalp block with 0.25% bupivacaine (20 mL) after the induction of general anesthesia but prior to head pinning Receives: Procedure: pre-pinning group |
| pre-emergence Group | Active comparator | Patients in this group will receive a scalp block with 0.25% bupivacaine (20 mL) at the end of surgery, before emergence from anesthesia. Receives: Procedure: pre-emergence Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: The observation period extended from the beginning of surgery until 24 hours postoperatively.
Secondary outcomes (4)
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.
Measured: 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.
Measured: Intraoperative (Hemodynamic parameters were monitored from the beginning to the end of surgery.)
Intraoperative and Postoperative Opioid Consumption
From induction to 24 hours postoperatively
Measured: 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.
Measured: 10 minutes, 2 hours, 6 hours, and 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start1 Jul 2025
- Primary completion25 Feb 2026
- Study completion27 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scalp BlockStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 60 patients undergoing elective supratentorial tumor craniotomy will be randomly assigned to one of two parallel groups (n=30 per group). Group 1 will receive a pre-pinning scalp block, while Group 2 will receive a pre-emergence scalp block. A blinded investigator will monitor intraoperative hemodynamic parameters and assess both intraoperative and postoperative opioid and analgesic consumption. Postoperatively, all patients will complete the validated Quality of Recovery-40 (QoR-40) questionnaire to evaluate recovery outcomes. The study aims to compare the effect of scalp block timing on postoperative recovery and analgesic requirements.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed Halit Tekeci, MD, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07043621
- Sponsor's protocol ID
- E-43012747-050.04-474853246
- Status last verified
- Jul 2026
- First submitted
- 18 Jun 2025
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scalp Block Before Head Pinning or Before Emergence in Supratentorial Tumor Craniotomy: A Randomized Controlled Evaluation of Quality of Recovery and Hemodynamic Responses
- ClinicalTrials.gov ID
- NCT07043621
- Acronym / sponsor ID
- E-43012747-050.04-474853246
- Conditions
- Scalp Block, Regional Anesthesia, Craniotomy Surgery, QoR-40
- Keywords
- Scalp Block, Craniotomy surgery, analgesia, postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 25 Feb 2026 (actual)
- Study completion
- 27 Feb 2026 (actual)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A total of 60 patients undergoing elective supratentorial tumor craniotomy will be randomly assigned to one of two parallel groups (n=30 per group). Group 1 will receive a pre-pinning scalp block, while Group 2 will receive a pre-emergence scalp block. A blinded investigator will monitor intraoperative hemodynamic parameters and assess both intraoperative and postoperative opioid and analgesic consumption. Postoperatively, all patients will complete the validated Quality of Recovery-40 (QoR-40) questionnaire to evaluate recovery outcomes. The study aims to compare the effect of scalp block timing on postoperative recovery and analgesic requirements.
| Arm | Type | Receives |
|---|---|---|
| pre-pinning group | Active comparator | Procedure: pre-pinning groupPatients in this group will receive a scalp block with 0.25% bupivacaine (20 mL) after the induction of general anesthesia but prior to head pinning |
| pre-emergence Group | Active comparator | Procedure: pre-emergence GroupPatients in this group will receive a scalp block with 0.25% bupivacaine (20 mL) at the end of surgery, before emergence from anesthesia. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pre-pinning groupAlso: Pre-pinning Scalp Block GroupFollowing 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 or surgery | pre-pinning group |
| pre-emergence GroupAlso: Pre-emergence Scalp Block GroupIn 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. | Procedure or surgery | pre-emergence Group |
Primary outcome
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).
4 secondary outcomes
Perioperative Hemodynamic Changes
Time frame: Intraoperative (Hemodynamic parameters were monitored from the beginning to the end of surgery.)
Perioperative Hemodynamic Changes
Time frame: Intraoperative (Hemodynamic parameters were monitored from the beginning to the end of surgery.)
Intraoperative and Postoperative Opioid Consumption
Time frame: Total opioid consumption will be recorded intraoperatively and within the first 24 hours postoperatively.
Postoperative Pain Scores
Time frame: 10 minutes, 2 hours, 6 hours, and 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pre-pinning group and pre-emergence Group in people with Scalp Block and Regional Anesthesia, run by Sakarya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Recovery Score (time frame: The observation period extended from the beginning of surgery until 24 hours postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.