Supratentorial TumorsPhase 4NCT07425678
Comparison of Systemic Opioid (Morphine) and Pre-Incision Bilateral Scalp Nerve Block for Pain Management in Craniotomy Patients
A Phase 4 study testing Scalp nerve block, Morphine and Lidocaine in people with Supratentorial Tumors, run by Aga Khan University at 1 site in Pakistan.
Trial summary
The goal of this randomized controlled clinical trial is to compare the effectiveness of systemic opioids versus pre-incision bilateral scalp nerve block in managing intraoperative noxious stimuli and postoperative pain in adult patients (18-75 years) undergoing elective supratentorial craniotomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Supratentorial Tumors
- What is being tested?
- Scalp nerve block, Morphine and Lidocaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2025to 30 Sep 2025
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years to 75 years,
- American Society of Anesthesiologists class I-III,
- Scheduled for supratentorial craniotomy.
Who cannot join
- Patient with Glasgow Coma Score (GCS) of less than 15,
- Inability to understand the Visual analog scale (VAS)
- Allergic to study drugs (Morphine and local anesthetics)
- Patient chronically treated with narcotic medications.
- History of Liver dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Analgesic Management Using Conventional Versus Regional Nerve Block in Craniotomy Surgeries in Lower Middle-Income Class Countries
The goal of this randomized controlled clinical trial is to compare the effectiveness of systemic opioids versus pre-incision bilateral scalp nerve block in managing intraoperative noxious stimuli and postoperative pain in adult patients (18-75 years) undergoing elective supratentorial craniotomy.
The main questions this study aims to answer are:
Read more
Does pre-incision bilateral scalp nerve block provide better intraoperative hemodynamic stability compared to systemic opioids?
Does it result in lower postoperative pain scores and reduced opioid consumption during the first 24 hours after surgery?
Researchers will compare Group M (systemic morphine) with Group S (bilateral scalp nerve block) to see if the scalp nerve block offers superior analgesia and fewer opioid-related side effects.
Participants will:
Be randomly assigned to receive either systemic morphine or bilateral scalp nerve block before incision.
Undergo standard general anesthesia for craniotomy.
Have postoperative pain managed using a patient-controlled analgesia (PCA) morphine pump and be monitored for 24 hours for pain, sedation, and nausea/vomiting scores
Read the detailed description
This double blinded, randomized controlled trial was conducted at Aga Khan University Hospital, Karachi, over a period of three to six months after obtaining approval from the institutional ethics committee. Non-probability consecutive sampling was used.
Eligible patients were randomly assigned using computer-generated randomization into two groups: Group M (morphine) and Group S (scalp nerve block). Pre-operatively, all patients were given explanations of the visual analogue scale (VAS) scores for pain assessment and how to operate the patient-controlled analgesia (PCA) machine for post-operative analgesia. Baseline heart rate and blood pressure were recorded after applying standard ASA monitors. Group M was given IV Morphine at induction 0.1mg/kg. In Group S, a bilateral scalp nerve block was performed after arterial line insertion using a mixture of lidocaine 0.1%, ropivacaine 0.25%, adrenaline 1:200,000, and dexamethasone 4 mg. The supraorbital, supratrochlear, auriculotemporal, zygomaticotemporal, greater, and lesser occipital nerves were blocked. In Group M, only pin sites were infiltrated with the same solution.
Intraoperative heart rate, systolic, diastolic, and mean arterial pressures were recorded at multiple surgical stages. Postoperatively, all patients received PCA morphine (1 mg/ml, 1 mg bolus, 10-minute lockout, no background infusion). Pain (VAS), sedation, and nausea/vomiting scores were assessed up to 24 hours postoperatively by a blinded observer.
- Conditions
- Supratentorial Tumors
- Being tested
- Scalp nerve block, Morphine, Lidocaine, Ropivacaine, Epinephrine (Adrenaline)
- Keywords
- Scalp Nerve Block, Craniotomy, Opioid-Sparing Technique, Regional versus Morphine
- Medical subject headings
- Supratentorial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scalp nerve blockProcedure or surgery
Also called SNB, Regional Nerve Block
Bilateral block of the following nerves:
- Supraorbital nerve
- Supratrochlear nerve
- Auriculotemporal nerve
- Zygomaticotemporal nerve
- Greater occipital nerve
- Lesser occipital nerve
MorphineDrug
Also called Opioid, Systemic Analgesia
Drug: Morphine
Dose: 0.1 mg/kg
Route: Intravenous
Timing: At induction of anesthesia
LidocaineDrug
Concentration: 0.1%
Route: Local infiltration
Used as part of scalp block mixture
RopivacaineDrug
Concentration: 0.25%
Route: Local infiltration
Used as part of scalp block mixture
Epinephrine (Adrenaline)Drug
Concentration: 1:200,000
Route: Local infiltration
Used as vasoconstrictor adjunct
DexamethasoneDrug
Dose: 4 mg
Route: Local Infiltration
Used as adjunct to prolong block duration
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Morphine | Active comparator | Participants receive intravenous Morphine 0.1mg/kg at induction. Receives: Drug: Morphine |
| Bilateral Scalp Nerve Block (SNB) | Experimental | Participants receive a bilateral scalp nerve block after arterial line insertion using local anesthetic agents with adjuvants. Receives: Procedure: Scalp nerve block; Drug: Lidocaine; Drug: Ropivacaine; Drug: Epinephrine (Adrenaline); Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Heart Rate Response to Noxious Stimuli
Heart rate (beats per minute) will be recorded on various noxious stimuli such as on intubation, 3 minutes after intubation, prior to scalp nerve block, 3 minutes after scalp nerve block, before head pinning, 1 and 3 minutes after head pinning, at surgical incision, 3 minutes after skin incision, during bone and periosteum dissection, Dural opening, Dural closing, skull bone closure, skin closure in patients undergoing for the supratentorial craniotomy.
Measured: Intraoperative Period- from induction of anesthesia until skin closure.
Intraoperative Systolic Blood Pressure Response to Noxious Stimuli
Systolic blood pressure (mmHg) measured at various noxious stimuli such as on intubation, 3 minutes after intubation, prior to scalp nerve block, 3 minutes after scalp nerve block, before head pinning, 1 and 3 minutes after head pinning, at surgical incision, 3 minutes after skin incision, during bone and periosteum dissection, Dural opening, Dural closing, skull bone closure, skin closure in patients undergoing for the supratentorial craniotomy.
Measured: Intraoperative Period- from induction of anesthesia until skin closure.
Intraoperative Diastolic Blood Pressure Response to Noxious Stimuli
Diastolic blood pressure (mmHg) measured at various noxious stimuli such as on intubation, 3 minutes after intubation, prior to scalp nerve block, 3 minutes after scalp nerve block, before head pinning, 1 and 3 minutes after head pinning, at surgical incision, 3 minutes after skin incision, during bone and periosteum dissection, Dural opening, Dural closing, skull bone closure, skin closure in patients undergoing for the supratentorial craniotomy.
Measured: Intraoperative Period- from induction of anesthesia until skin closure.
Intraoperative Mean Arterial Pressure Response to Noxious Stimuli
Mean arterial pressure (mmHg) measured at various noxious stimuli such as on intubation, 3 minutes after intubation, prior to scalp nerve block, 3 minutes after scalp nerve block, before head pinning, 1 and 3 minutes after head pinning, at surgical incision, 3 minutes after skin incision, during bone and periosteum dissection, Dural opening, Dural closing, skull bone closure, skin closure in patients undergoing for the supratentorial craniotomy.
Measured: Intraoperative Period- from induction of anesthesia until skin closure.
Secondary outcomes (4)
Postoperative Pain Intensity Measured by Visual Analog Scale (VAS)
Postoperative pain will be assessed using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 to 10, where:
0 = No pain 10 = Worst imaginable pain Higher scores indicate worse pain.
Pain will be assessed at predefined intervals within the first 24 hours after surgery.
Measured: 0-24 hours postoperatively
Total Postoperative Morphine Consumption in First 24 Hours
Total cumulative morphine consumption (mg) administered within the first 24 hours after surgery.
Measured: 0-24 hours postoperatively
Postoperative Sedation Score Measured by 4-Point Sedation Scale
Sedation will be assessed using a 4-point sedation scale:
- = Awake and alert
- = Drowsy, responsive to verbal stimuli
- = Drowsy, arousable to physical stimuli
- = Unarousable Higher scores indicate deeper sedation.
Measured: 0-24 hours postoperatively
Incidence of Postoperative Nausea/ Vomiting Within 24 Hours
Nausea/Vomiting will be assessed using a four-point scale:
0= No nausea and vomiting
- Mild nausea
- Severe nausea with retching
- Vomiting
Measured: 0-24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start1 Jan 2025
- Primary completion1 Jul 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Supratentorial TumorsStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It is a double blinded, randomized controlled trial with non-probability consecutive sampling
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dileep Kumar, Aga Khan University
- Investigators
- Dileep Kumar, MBBS, FCPS, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07425678
- Sponsor's protocol ID
- ERC NUMBER- 2025-9126-34025
- Status last verified
- Jan 2026
- First submitted
- 30 Jan 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dilmen OK, Akcil EF, Tunali Y, Karabulut ES, Bahar M, Altindas F, Vehid H, Yentur E. Postoperative analgesia for supratentorial craniotomy. Clin Neurol Neurosurg. 2016 Jul;146:90-5. doi: 10.1016/j.clineuro.2016.04.026. Epub 2016 May 4.
PubMed 27164511Jayaram K, Srilata M, Kulkarni D, Ramachandran G. Regional Anesthesia to Scalp for Craniotomy: Innovation With Innervation. J Neurosurg Anesthesiol. 2016 Jan;28(1):32-7. doi: 10.1097/ANA.0000000000000184.
PubMed 26083426Tuchinda, Lawan & Somboonviboon, Wanna & Supbornsug, Kaew & Worathongchai, Sukhumakorn & Limutaitip, Supodjanee. (2010). Bupivacaine scalp nerve block: Hemodynamic response during craniotomy, intraoperative and post-operative analgesia. Asian Biomedicine. 4. 10.2478/abm-2010-0031.
Nguyen A, Girard F, Boudreault D, Fugere F, Ruel M, Moumdjian R, Bouthilier A, Caron JL, Bojanowski MW, Girard DC. Scalp nerve blocks decrease the severity of pain after craniotomy. Anesth Analg. 2001 Nov;93(5):1272-6. doi: 10.1097/00000539-200111000-00048.
PubMed 11682413Ayoub C, Girard F, Boudreault D, Chouinard P, Ruel M, Moumdjian R. A comparison between scalp nerve block and morphine for transitional analgesia after remifentanil-based anesthesia in neurosurgery. Anesth Analg. 2006 Nov;103(5):1237-40. doi: 10.1213/01.ane.0000244319.51957.9f.
PubMed 17056961
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Analgesic Management Using Conventional Versus Regional Nerve Block in Craniotomy Surgeries in Lower Middle-Income Class Countries
- ClinicalTrials.gov ID
- NCT07425678
- Acronym / sponsor ID
- ERC NUMBER- 2025-9126-34025
- Conditions
- Supratentorial Tumors
- Keywords
- Scalp Nerve Block, Craniotomy, Opioid-Sparing Technique, Regional versus Morphine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 23 Feb 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.
The goal of this randomized controlled clinical trial is to compare the effectiveness of systemic opioids versus pre-incision bilateral scalp nerve block in managing intraoperative noxious stimuli and postoperative pain in adult patients (18-75 years) undergoing elective supratentorial craniotomy.
The main questions this study aims to answer are:
Does pre-incision bilateral scalp nerve block provide better intraoperative hemodynamic stability compared to systemic opioids?
Does it result in lower postoperative pain scores and reduced opioid consumption during the first 24 hours after surgery?
Researchers will compare Group M (systemic morphine) with Group S (bilateral scalp nerve block) to see if the scalp nerve block offers superior analgesia and fewer opioid-related side effects.
Participants will:
Be randomly assigned to receive either systemic morphine or bilateral scalp nerve block before incision.
Undergo standard general anesthesia for craniotomy.
Have postoperative pain managed using a patient-controlled analgesia (PCA) morphine pump and be monitored for 24 hours for pain, sedation, and nausea/vomiting scores
Detailed description
This double blinded, randomized controlled trial was conducted at Aga Khan University Hospital, Karachi, over a period of three to six months after obtaining approval from the institutional ethics committee. Non-probability consecutive sampling was used.
Eligible patients were randomly assigned using computer-generated randomization into two groups: Group M (morphine) and Group S (scalp nerve block). Pre-operatively, all patients were given explanations of the visual analogue scale (VAS) scores for pain assessment and how to operate the patient-controlled analgesia (PCA) machine for post-operative analgesia. Baseline heart rate and blood pressure were recorded after applying standard ASA monitors. Group M was given IV Morphine at induction 0.1mg/kg. In Group S, a bilateral scalp nerve block was performed after arterial line insertion using a mixture of lidocaine 0.1%, ropivacaine 0.25%, adrenaline 1:200,000, and dexamethasone 4 mg. The supraorbital, supratrochlear, auriculotemporal, zygomaticotemporal, greater, and lesser occipital nerves were blocked. In Group M, only pin sites were infiltrated with the same solution.
Intraoperative heart rate, systolic, diastolic, and mean arterial pressures were recorded at multiple surgical stages. Postoperatively, all patients received PCA morphine (1 mg/ml, 1 mg bolus, 10-minute lockout, no background infusion). Pain (VAS), sedation, and nausea/vomiting scores were assessed up to 24 hours postoperatively by a blinded observer.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- It is a double blinded, randomized controlled trial with non-probability consecutive sampling
| Arm | Type | Receives |
|---|---|---|
| Intravenous Morphine | Active comparator | Drug: MorphineParticipants receive intravenous Morphine 0.1mg/kg at induction. |
| Bilateral Scalp Nerve Block (SNB) | Experimental | Procedure: Scalp nerve block, Drug: Lidocaine, Drug: Ropivacaine, Drug: Epinephrine (Adrenaline), Drug: DexamethasoneParticipants receive a bilateral scalp nerve block after arterial line insertion using local anesthetic agents with adjuvants. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years to 75 years,
- American Society of Anesthesiologists class I-III,
- Scheduled for supratentorial craniotomy.
Key exclusion criteria (5 listed)
- Patient with Glasgow Coma Score (GCS) of less than 15,
- Inability to understand the Visual analog scale (VAS)
- Allergic to study drugs (Morphine and local anesthetics)
- Patient chronically treated with narcotic medications.
- History of Liver 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 |
|---|---|---|
| Scalp nerve blockAlso: SNB, Regional Nerve BlockBilateral block of the following nerves: * Supraorbital nerve * Supratrochlear nerve * Auriculotemporal nerve * Zygomaticotemporal nerve * Greater occipital nerve * Lesser occipital nerve | Procedure or surgery | Bilateral Scalp Nerve Block (SNB) |
| MorphineAlso: Opioid, Systemic AnalgesiaDrug: Morphine Dose: 0.1 mg/kg Route: Intravenous Timing: At induction of anesthesia | Drug | Intravenous Morphine |
| LidocaineConcentration: 0.1% Route: Local infiltration Used as part of scalp block mixture | Drug | Bilateral Scalp Nerve Block (SNB) |
| RopivacaineConcentration: 0.25% Route: Local infiltration Used as part of scalp block mixture | Drug | Bilateral Scalp Nerve Block (SNB) |
| Epinephrine (Adrenaline)Concentration: 1:200,000 Route: Local infiltration Used as vasoconstrictor adjunct | Drug | Bilateral Scalp Nerve Block (SNB) |
| DexamethasoneDose: 4 mg Route: Local Infiltration Used as adjunct to prolong block duration | Drug | Bilateral Scalp Nerve Block (SNB) |
Primary outcome
Intraoperative Heart Rate Response to Noxious Stimuli
Time frame: Intraoperative Period- from induction of anesthesia until skin closure.
Heart rate (beats per minute) will be recorded on various noxious stimuli such as on intubation, 3 minutes after intubation, prior to scalp nerve block, 3 minutes after scalp nerve block, before head pinning, 1 and 3 minutes after head pinning, at surgical incision, 3 minutes after skin incision, during bone and periosteum dissection, Dural opening, Dural closing, skull bone closure, skin closure in patients undergoing for the supratentorial craniotomy.
Intraoperative Systolic Blood Pressure Response to Noxious Stimuli
Time frame: Intraoperative Period- from induction of anesthesia until skin closure.
Systolic blood pressure (mmHg) measured at various noxious stimuli such as on intubation, 3 minutes after intubation, prior to scalp nerve block, 3 minutes after scalp nerve block, before head pinning, 1 and 3 minutes after head pinning, at surgical incision, 3 minutes after skin incision, during bone and periosteum dissection, Dural opening, Dural closing, skull bone closure, skin closure in patients undergoing for the supratentorial craniotomy.
Intraoperative Diastolic Blood Pressure Response to Noxious Stimuli
Time frame: Intraoperative Period- from induction of anesthesia until skin closure.
Diastolic blood pressure (mmHg) measured at various noxious stimuli such as on intubation, 3 minutes after intubation, prior to scalp nerve block, 3 minutes after scalp nerve block, before head pinning, 1 and 3 minutes after head pinning, at surgical incision, 3 minutes after skin incision, during bone and periosteum dissection, Dural opening, Dural closing, skull bone closure, skin closure in patients undergoing for the supratentorial craniotomy.
Intraoperative Mean Arterial Pressure Response to Noxious Stimuli
Time frame: Intraoperative Period- from induction of anesthesia until skin closure.
Mean arterial pressure (mmHg) measured at various noxious stimuli such as on intubation, 3 minutes after intubation, prior to scalp nerve block, 3 minutes after scalp nerve block, before head pinning, 1 and 3 minutes after head pinning, at surgical incision, 3 minutes after skin incision, during bone and periosteum dissection, Dural opening, Dural closing, skull bone closure, skin closure in patients undergoing for the supratentorial craniotomy.
4 secondary outcomes
Postoperative Pain Intensity Measured by Visual Analog Scale (VAS)
Time frame: 0-24 hours postoperatively
Total Postoperative Morphine Consumption in First 24 Hours
Time frame: 0-24 hours postoperatively
Postoperative Sedation Score Measured by 4-Point Sedation Scale
Time frame: 0-24 hours postoperatively
Incidence of Postoperative Nausea/ Vomiting Within 24 Hours
Time frame: 0-24 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 23 Feb 2026.
- Background: PubMed 27164511Dilmen OK, Akcil EF, Tunali Y, Karabulut ES, Bahar M, Altindas F, Vehid H, Yentur E. Postoperative analgesia for supratentorial craniotomy. Clin Neurol Neurosurg. 2016 Jul;146:90-5. doi: 10.1016/j.clineuro.2016.04.026. Epub 2016 May 4.
- Background: PubMed 26083426Jayaram K, Srilata M, Kulkarni D, Ramachandran G. Regional Anesthesia to Scalp for Craniotomy: Innovation With Innervation. J Neurosurg Anesthesiol. 2016 Jan;28(1):32-7. doi: 10.1097/ANA.0000000000000184.
- BackgroundTuchinda, Lawan & Somboonviboon, Wanna & Supbornsug, Kaew & Worathongchai, Sukhumakorn & Limutaitip, Supodjanee. (2010). Bupivacaine scalp nerve block: Hemodynamic response during craniotomy, intraoperative and post-operative analgesia. Asian Biomedicine. 4. 10.2478/abm-2010-0031.
- Background: PubMed 11682413Nguyen A, Girard F, Boudreault D, Fugere F, Ruel M, Moumdjian R, Bouthilier A, Caron JL, Bojanowski MW, Girard DC. Scalp nerve blocks decrease the severity of pain after craniotomy. Anesth Analg. 2001 Nov;93(5):1272-6. doi: 10.1097/00000539-200111000-00048.
- Background: PubMed 17056961Ayoub C, Girard F, Boudreault D, Chouinard P, Ruel M, Moumdjian R. A comparison between scalp nerve block and morphine for transitional analgesia after remifentanil-based anesthesia in neurosurgery. Anesth Analg. 2006 Nov;103(5):1237-40. doi: 10.1213/01.ane.0000244319.51957.9f.
- Individual participant dataSharing planned: No
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Supratentorial Tumors
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.
Dileep Kumar, MBBS, FCPS principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Scalp nerve block, Morphine and Lidocaine in people with Supratentorial Tumors, run by Aga Khan University at 1 site in Pakistan.
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 3 inclusion and 5 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 23 Feb 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 Pakistan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Intraoperative Heart Rate Response to Noxious Stimuli (time frame: Intraoperative Period- from induction of anesthesia until skin closure.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07425678, which also lists 5 linked publications.
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 23 Feb 2026.