DexamethasoneNCT07788261
Adding Dexamethasone to Lidocaine in Scalp Incision Infiltration for Craniotomy
A study testing Xylocaine plus Dexamethasone and Xylocaine plus epinephrine in people with Dexamethasone and Lidocaine, run by Assiut University at 1 site in Egypt.
Trial summary
This study aimed to test the hypothesis that pre-emptive scalp infiltration with a steroid (dexamethasone) plus a local anesthetic (xylocaine) could achieve superior postoperative analgesic effects to a local anesthetic (xylocaine) plus epinephrine in adult patients undergoing a craniotomy. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Dexamethasone, Lidocaine, Scalp Incision Infiltration
- What is being tested?
- Xylocaine plus Dexamethasone and Xylocaine plus epinephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 1 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients age between 20 and 60 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I and II
- Scheduled for elective supratentorial tumor craniotomy under general anesthesia.
Who cannot join
- Patients with known hypersensitivity to lidocaine or dexamethasone.
- Chronic corticosteroid therapy.
- Pre-existing coagulopathy.
- Significant hepatic or renal impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Adding Dexamethasone to Lidocaine in Scalp Incision Infiltration for Craniotomy
This study aimed to test the hypothesis that pre-emptive scalp infiltration with a steroid (dexamethasone) plus a local anesthetic (xylocaine) could achieve superior postoperative analgesic effects to a local anesthetic (xylocaine) plus epinephrine in adult patients undergoing a craniotomy.
Read the detailed description
Approximately 55-87% of patients undergoing craniotomy experience moderate to severe pain during the first 48 hours after surgery, which negatively influences their postoperative rehabilitation.
Recently, local infiltration of analgesia (LIA) has been widely performed clinically as a promising analgesic method that could avoid the side effects of analgesics but only has a short pain-free duration; researchers have clarified that the addition of dexamethasone to LIA could provide significant analgesic effects and significantly prolong the duration of analgesic effects without obvious complications for various types of surgeries.
To date, no studies have evaluated the addition of dexamethasone to LIA for patients receiving craniotomy.
- Conditions
- Dexamethasone, Lidocaine, Scalp Incision Infiltration, Craniotomy
- Being tested
- Xylocaine plus Dexamethasone, Xylocaine plus epinephrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xylocaine plus DexamethasoneDrug
Patients received the incision site infiltration of 2% xylocaine plus dexamethasone.
Xylocaine plus epinephrineDrug
Patients received the incision site infiltration of 2% xylocaine plus epinephrine.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone group | Experimental | Patients received the incision site infiltration of 2% xylocaine plus dexamethasone. Receives: Drug: Xylocaine plus Dexamethasone |
| Control group | Active comparator | Patients received the incision site infiltration of 2% xylocaine plus epinephrine. Receives: Drug: Xylocaine plus epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of pain
Degree of pain was measured using the Numerical Rating Scale after surgery (numeric rating scale (NRS); 0 = no pain, 10 = worst imaginable pain)
Measured: 48 hours postoperatively
Total opioid consumption
Total postoperative opioid (fentanyl) consumption was recorded.
Measured: 48 hours postoperatively
Secondary outcomes (5)
Mean arterial pressure
Mean arterial pressure was measured during induction and every fifteen minutes after that.
Measured: Till the end of surgery (Up to 2 hours)
Heart rate
Heart rate was measured during induction and every fifteen minutes after that
Measured: Till the end of surgery (Up to 2 hours)
Time to first postoperative analgesic request
The time to the first postoperative analgesic request was recorded from the end of surgery till the first dose of fentanyl administered.
Measured: 48 hours postoperatively
Incidence of postoperative nausea and vomiting
Incidence of postoperative nausea and vomiting was recorded.
Measured: 48 hours postoperatively
Degree of patient satisfaction
Degree of patient satisfaction was assessed on a 5-point Likert scale (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied)
Measured: 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start1 Dec 2024
- Primary completion1 Feb 2026
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DexamethasoneStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Elsonbaty, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788261
- Sponsor's protocol ID
- 04-2025-300572
- Status last verified
- Aug 2026
- First submitted
- 23 Aug 2026
- Last updated
- 26 Aug 2026
- 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 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Dexamethasone to Lidocaine in Scalp Incision Infiltration for Craniotomy
- ClinicalTrials.gov ID
- NCT07788261
- Acronym / sponsor ID
- 04-2025-300572
- Conditions
- Dexamethasone, Lidocaine, Scalp Incision Infiltration, Craniotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 26 Aug 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 study aimed to test the hypothesis that pre-emptive scalp infiltration with a steroid (dexamethasone) plus a local anesthetic (xylocaine) could achieve superior postoperative analgesic effects to a local anesthetic (xylocaine) plus epinephrine in adult patients undergoing a craniotomy.
Detailed description
Approximately 55-87% of patients undergoing craniotomy experience moderate to severe pain during the first 48 hours after surgery, which negatively influences their postoperative rehabilitation.
Recently, local infiltration of analgesia (LIA) has been widely performed clinically as a promising analgesic method that could avoid the side effects of analgesics but only has a short pain-free duration; researchers have clarified that the addition of dexamethasone to LIA could provide significant analgesic effects and significantly prolong the duration of analgesic effects without obvious complications for various types of surgeries.
To date, no studies have evaluated the addition of dexamethasone to LIA for patients receiving craniotomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone group | Experimental | Drug: Xylocaine plus DexamethasonePatients received the incision site infiltration of 2% xylocaine plus dexamethasone. |
| Control group | Active comparator | Drug: Xylocaine plus epinephrinePatients received the incision site infiltration of 2% xylocaine plus epinephrine. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients age between 20 and 60 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I and II
- Scheduled for elective supratentorial tumor craniotomy under general anesthesia.
Key exclusion criteria (4 listed)
- Patients with known hypersensitivity to lidocaine or dexamethasone.
- Chronic corticosteroid therapy.
- Pre-existing coagulopathy.
- Significant hepatic or renal impairment.
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 |
|---|---|---|
| Xylocaine plus DexamethasonePatients received the incision site infiltration of 2% xylocaine plus dexamethasone. | Drug | Dexamethasone group |
| Xylocaine plus epinephrinePatients received the incision site infiltration of 2% xylocaine plus epinephrine. | Drug | Control group |
Primary outcome
Degree of pain
Time frame: 48 hours postoperatively
Degree of pain was measured using the Numerical Rating Scale after surgery (numeric rating scale (NRS); 0 = no pain, 10 = worst imaginable pain)
Total opioid consumption
Time frame: 48 hours postoperatively
Total postoperative opioid (fentanyl) consumption was recorded.
5 secondary outcomes
Mean arterial pressure
Time frame: Till the end of surgery (Up to 2 hours)
Heart rate
Time frame: Till the end of surgery (Up to 2 hours)
Time to first postoperative analgesic request
Time frame: 48 hours postoperatively
Incidence of postoperative nausea and vomiting
Time frame: 48 hours postoperatively
Degree of patient satisfaction
Time frame: 48 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 26 Aug 2026.
- 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. 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 Xylocaine plus Dexamethasone and Xylocaine plus epinephrine in people with Dexamethasone and Lidocaine, run by Assiut 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 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 26 Aug 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.
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?
Degree of pain (time frame: 48 hours postoperatively). The study lists 2 primary outcomes in all. 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 26 Aug 2026.