Post-Craniotomy HeadachePhase 2NCT07510217
ERAS Approach for Post-Craniotomy Headache and Psychological Recovery
A Phase 2 study testing Scalp block with 0.5% plain Marcaine, dexmedetomidine and Intraoperative Analgesia in people with Post-Craniotomy Headache, run by Tanta University at 1 site in Egypt.
Trial summary
This randomized multicenter study involves patients undergoing intracranial surgeries (Population) to evaluate whether a perioperative analgesia protocol including scalp block (SB) with dexmedetomidine (DEX) infusion (Intervention) reduces the incidence and severity of post-craniotomy headache (PCH) compared to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Craniotomy Headache
- What is being tested?
- Scalp block with 0.5% plain Marcaine, dexmedetomidine and Intraoperative Analgesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2024to 20 Feb 2026
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing supratentorial or intracranial surgery;
- signed informed consent.
Who cannot join
- History of chronic headache disorders;
- allergy to study medications;
- emergency surgeries;
- inability to perform psychological or cognitive testing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhanced Recovery After Surgery Approach May Mitigate Post-craniotomy Headache and Psychological Derangement
This randomized multicenter study involves patients undergoing intracranial surgeries (Population) to evaluate whether a perioperative analgesia protocol including scalp block (SB) with dexmedetomidine (DEX) infusion (Intervention) reduces the incidence and severity of post-craniotomy headache (PCH) compared to standard opioid-based perioperative analgesia (Comparison). The study aims to determine if this Enhanced Recovery After Surgery (ERAS) approach mitigates postoperative pain, reduces opioid consumption, and improves psychological outcomes, including anxiety, depression, and sleep quality.
- Conditions
- Post-Craniotomy Headache
- Being tested
- Scalp block with 0.5% plain Marcaine, dexmedetomidine, Intraoperative Analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scalp block with 0.5% plain MarcaineDrug
A regional anesthetic block targeting the major sensory nerves of the scalp (supraorbital, supratrochlear, zygomaticotemporal, auriculotemporal, greater occipital, and lesser occipital nerves). To provide dense, long-acting local analgesia to the surgical site, preventing the transmission of pain signals during the craniotomy.
dexmedetomidineDrug
Started intraoperatively and maintained as a continuous infusion until the end of the first postoperative day. To provide systemic analgesia, hemodynamic stability, and anxiolytic (anti-anxiety) effects to mitigate psychological distress and improve sleep quality post-surgery.
Intraoperative AnalgesiaDrug
Conventional opioid-based anesthesia. This typically involves the intravenous (IV) administration of strong opioids such as Fentanyl or Sufentanil to manage the intense pain during the craniotomy (bone flap removal) and dural opening.
Intermittent boluses or continuous infusion of opioids as determined by the anesthesiologist based on the patient's hemodynamic response (heart rate and blood pressure).
| Study group | Role | What they receive |
|---|---|---|
| ERAS Analgesia Group | Active comparator | Patients undergoing intracranial surgery receiving the suggested ERAS protocol. Receives: Drug: Scalp block with 0.5% plain Marcaine; Drug: dexmedetomidine |
| Standard Opioid-Based Group | Active comparator | Patients undergoing intracranial surgery receiving conventional analgesic management. Receives: Drug: Intraoperative Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate of Treatment in Mitigating Post-Craniotomy Headache (PCH).
Evaluation of the incidence and severity of PCH using the Visual Analogue Scale (VAS) and the Headache Impact Test-6 (HIT-6).
Measured: Immediately postoperative through 4 weeks of follow-up.
Secondary outcomes (1)
Impact of Analgesic Regimen on Postoperative Cognitive Function (CF)
Evaluation of cognitive status using the Mini-Mental State Examination (MMSE). A score of <25 is used to define the presence of cognitive dysfunction (CD).
Measured: Assessed at three specific intervals: Baseline: Preoperatively (to establish the patient's normal function). POW2: Two weeks after surgery. POW4: Four weeks after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start10 Aug 2024
- Primary completion25 Dec 2025
- Study completion20 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Craniotomy HeadacheStudies of the same condition, open and under way.
- More trials run by Tanta 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of two distinct groups (arms) simultaneously. Each group follows a specific protocol throughout the study duration to allow for a direct head-to-head comparison of outcomes.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed B. Abo elkheer, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07510217
- Sponsor's protocol ID
- 36264PR789/7/24
- Status last verified
- Mar 2026
- First submitted
- 29 Mar 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery After Surgery Approach May Mitigate Post-craniotomy Headache and Psychological Derangement
- ClinicalTrials.gov ID
- NCT07510217
- Acronym / sponsor ID
- 36264PR789/7/24
- Conditions
- Post-Craniotomy Headache
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 10 Aug 2024 (actual)
- Primary completion
- 25 Dec 2025 (actual)
- Study completion
- 20 Feb 2026 (actual)
- First posted
- 3 Apr 2026 (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 randomized multicenter study involves patients undergoing intracranial surgeries (Population) to evaluate whether a perioperative analgesia protocol including scalp block (SB) with dexmedetomidine (DEX) infusion (Intervention) reduces the incidence and severity of post-craniotomy headache (PCH) compared to standard opioid-based perioperative analgesia (Comparison). The study aims to determine if this Enhanced Recovery After Surgery (ERAS) approach mitigates postoperative pain, reduces opioid consumption, and improves psychological outcomes, including anxiety, depression, and sleep quality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two distinct groups (arms) simultaneously. Each group follows a specific protocol throughout the study duration to allow for a direct head-to-head comparison of outcomes.
| Arm | Type | Receives |
|---|---|---|
| ERAS Analgesia Group | Active comparator | Drug: Scalp block with 0.5% plain Marcaine, Drug: dexmedetomidinePatients undergoing intracranial surgery receiving the suggested ERAS protocol. |
| Standard Opioid-Based Group | Active comparator | Drug: Intraoperative AnalgesiaPatients undergoing intracranial surgery receiving conventional analgesic management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing supratentorial or intracranial surgery;
- signed informed consent.
Key exclusion criteria (4 listed)
- History of chronic headache disorders;
- allergy to study medications;
- emergency surgeries;
- inability to perform psychological or cognitive testing.
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 |
|---|---|---|
| Scalp block with 0.5% plain MarcaineA regional anesthetic block targeting the major sensory nerves of the scalp (supraorbital, supratrochlear, zygomaticotemporal, auriculotemporal, greater occipital, and lesser occipital nerves). To provide dense, long-acting local analgesia to the surgical site, preventing the transmission of pain signals during the craniotomy. | Drug | ERAS Analgesia Group |
| dexmedetomidineStarted intraoperatively and maintained as a continuous infusion until the end of the first postoperative day. To provide systemic analgesia, hemodynamic stability, and anxiolytic (anti-anxiety) effects to mitigate psychological distress and improve sleep quality post-surgery. | Drug | ERAS Analgesia Group |
| Intraoperative AnalgesiaConventional opioid-based anesthesia. This typically involves the intravenous (IV) administration of strong opioids such as Fentanyl or Sufentanil to manage the intense pain during the craniotomy (bone flap removal) and dural opening. Intermittent boluses or continuous infusion of opioids as determined by the anesthesiologist based on the patient's hemodynamic response (heart rate and blood pressure). | Drug | Standard Opioid-Based Group |
Primary outcome
Success Rate of Treatment in Mitigating Post-Craniotomy Headache (PCH).
Time frame: Immediately postoperative through 4 weeks of follow-up.
Evaluation of the incidence and severity of PCH using the Visual Analogue Scale (VAS) and the Headache Impact Test-6 (HIT-6).
1 secondary outcome
Impact of Analgesic Regimen on Postoperative Cognitive Function (CF)
Time frame: Assessed at three specific intervals: Baseline: Preoperatively (to establish the patient's normal function). POW2: Two weeks after surgery. POW4: Four weeks after surgery.
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 3 Apr 2026.
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 Phase 2 study testing Scalp block with 0.5% plain Marcaine, dexmedetomidine and Intraoperative Analgesia in people with Post-Craniotomy Headache, run by Tanta University at 1 site in Egypt.
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 2 inclusion and 4 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 3 Apr 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 Egypt. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Success Rate of Treatment in Mitigating Post-Craniotomy Headache (PCH). (time frame: Immediately postoperative through 4 weeks of follow-up.). 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 3 Apr 2026.