DexmedetomidineNCT06993922
Dexmedetomidine as an Adjuvant to Bupivacaine in Scalp Block Versus Bupivacaine Alone for Postoperative Pain Management in Patients Undergoing Craniotomy
A study testing Scalp block and Scalp block + Dexmedetomidine in people with Dexmedetomidine and Adjuvant, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aims to compare dexmedetomidine as an adjuvant to bupivacaine in scalp block versus bupivacaine alone for postoperative pain management in patients undergoing craniotomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dexmedetomidine, Adjuvant, Bupivacaine
- What is being tested?
- Scalp block and Scalp block + Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 29 May 2025to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 65 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I or II.
- Undergoing supratentorial elective planned craniotomies.
Who cannot join
- Patients refusal.
- History of known allergy to the used local anesthetic or dexmedetomidine.
- Bleeding disorders.
- Evidence of local infection at the site of injection.
- Emergency craniotomy.
- Psychotic disorder.
- Patients who will not be extubated in the operating room after surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo, 11591
Omar A Khiralla, Master, 00201095281838, Omar-Ahmed@med.asu.edu.eg
Hanaa M AbdAllah, MD
About this study
This study aims to compare dexmedetomidine as an adjuvant to bupivacaine in scalp block versus bupivacaine alone for postoperative pain management in patients undergoing craniotomy.
Read the detailed description
Scalp block is proposed as a multimodal approach to preventing postoperative pain and hemodynamic responses to previous noxious stimulation during the operation.
The use of adjuvants, such as dexmedetomidine, a highly selective alpha-2 adrenergic receptor agonist, has recently been studied for its analgesic effects. Dexmedetomidine acts additionally to local anesthetics, prolonging their duration of action.
- Conditions
- Dexmedetomidine, Adjuvant, Bupivacaine, Scalp Block, Postoperative Pain, Craniotomy
- Being tested
- Scalp block, Scalp block + Dexmedetomidine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scalp blockOther
Also called Bupivacaine
Patients will receive a scalp block with bupivacaine alone.
Scalp block + DexmedetomidineOther
Also called Bupivacaine + Dexmedetomidine
Patients will receive a scalp block with dexmedetomidine as an adjuvant to bupivacaine.
| Study group | Role | What they receive |
|---|---|---|
| Group SB | Active comparator | Patients will receive a scalp block with bupivacaine alone. Receives: Other: Scalp block |
| Group SD | Experimental | Patients will receive a scalp block with dexmedetomidine as an adjuvant to bupivacaine. Receives: Other: Scalp block + Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative postoperative morphine consumption
If the Visual Analogue Scale (VAS) score is ≥3, rescue analgesia will be administered; intravenous morphine will be given at a dose of 0.05 mg/kg
Measured: 24 hours postoperatively
Secondary outcomes (5)
Mean arterial pressure
Mean arterial pressure will be measured at baseline, before Mayfield placement, 5 minutes after Mayfield insertion, at the end of surgery, and postoperatively at 2, 4, 6,12, and 24 hours postoperatively.
Measured: 24 hours postoperatively
Heart rate
Heart rate will be measured at baseline, before Mayfield placement, 5 minutes after Mayfield insertion, at the end of surgery, and 2, 4, 6, 12, and 24 hours postoperatively.
Measured: 24 hours postoperatively
Degree of pain
Pain intensity will be evaluated on a 0-10 visual analog scale (VAS). The VAS consists of a 10 cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). The VAS score will be recorded at baseline (after admission to PACU), then after 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, and 24 hours postoperatively.
Measured: 24 hours postoperatively
Time for 1st rescue analgesia
Time for 1st rescue analgesia will be recorded from the end of surgery till first dose of morphine administrated.
Measured: 24 hours postoperatively
Incidence of complications
Incidence of complications such as postoperative nausea and vomiting, respiratory depression, or any other complication will be recorded.
Measured: 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 May 2025
- Study start29 May 2025
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DexmedetomidineStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Ahmed Zakaria Khiralla, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06993922
- Sponsor's protocol ID
- FMASU MS 57/2025
- Status last verified
- May 2025
- First submitted
- 20 May 2025
- Last updated
- 30 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine as an Adjuvant to Bupivacaine in Scalp Block Versus Bupivacaine Alone for Postoperative Pain Management in Patients Undergoing Craniotomy
- ClinicalTrials.gov ID
- NCT06993922
- Acronym / sponsor ID
- FMASU MS 57/2025
- Conditions
- Dexmedetomidine, Adjuvant, Bupivacaine, Scalp Block, Postoperative Pain, Craniotomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 29 May 2025 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 29 May 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 compare dexmedetomidine as an adjuvant to bupivacaine in scalp block versus bupivacaine alone for postoperative pain management in patients undergoing craniotomy.
Detailed description
Scalp block is proposed as a multimodal approach to preventing postoperative pain and hemodynamic responses to previous noxious stimulation during the operation.
The use of adjuvants, such as dexmedetomidine, a highly selective alpha-2 adrenergic receptor agonist, has recently been studied for its analgesic effects. Dexmedetomidine acts additionally to local anesthetics, prolonging their duration of action.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group SB | Active comparator | Other: Scalp blockPatients will receive a scalp block with bupivacaine alone. |
| Group SD | Experimental | Other: Scalp block + DexmedetomidinePatients will receive a scalp block with dexmedetomidine as an adjuvant to bupivacaine. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age from 18 to 65 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I or II.
- Undergoing supratentorial elective planned craniotomies.
Key exclusion criteria (7 listed)
- Patients refusal.
- History of known allergy to the used local anesthetic or dexmedetomidine.
- Bleeding disorders.
- Evidence of local infection at the site of injection.
- Emergency craniotomy.
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 blockAlso: BupivacainePatients will receive a scalp block with bupivacaine alone. | Other | Group SB |
| Scalp block + DexmedetomidineAlso: Bupivacaine + DexmedetomidinePatients will receive a scalp block with dexmedetomidine as an adjuvant to bupivacaine. | Other | Group SD |
Primary outcome
Cumulative postoperative morphine consumption
Time frame: 24 hours postoperatively
If the Visual Analogue Scale (VAS) score is ≥3, rescue analgesia will be administered; intravenous morphine will be given at a dose of 0.05 mg/kg
5 secondary outcomes
Mean arterial pressure
Time frame: 24 hours postoperatively
Heart rate
Time frame: 24 hours postoperatively
Degree of pain
Time frame: 24 hours postoperatively
Time for 1st rescue analgesia
Time frame: 24 hours postoperatively
Incidence of complications
Time frame: 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scalp block and Scalp block + Dexmedetomidine in people with Dexmedetomidine and Adjuvant, run by Ain Shams 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 30 May 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Omar A Khiralla, MBBCH (00201095281838, Omar-Ahmed@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative postoperative morphine consumption (time frame: 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 30 May 2025.