Postoperative PainNCT06406829
Perioperative Multimodal Analgesia Protocol for Supratentorial Craniotomy
A study testing Dexmedetomidine, Normal saline and Local analgesic techniques in people with Postoperative Pain and Analgesia, run by Beijing Tiantan Hospital.
Trial summary
Supratentorial craniotomy is one of the most common neurosurgical procedures, with severe perioperative pain. Inadequate perioperative pain relief has been associated with increased blood pressure and intracranial pressure, favoring bleeding and cerebral cerebral hypoperfusion. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain, Analgesia, Supratentorial Brain Tumor
- What is being tested?
- Dexmedetomidine, Normal saline and Local analgesic techniques
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 9 Feb 2026to 31 Dec 2027
- 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
- Aged from 18 to 65 years
- American Society of Anesthesiologists physical status I to III
- Scheduled to undergo elective supratentorial tumor resection
Who cannot join
- Incision-area skin infection
- A history of previous craniotomy
- Allergy to study medications
- A history of preoperative change in consciousness or cognitive function
- Severe hepatic or renal dysfunction
- Severe bradycardia (heart rate<40 beats/min)
- Sick sinus syndrome or second- to-third degree atrioventricular block
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Perioperative Multimodal Analgesia Protocol for Supratentorial Craniotomy：a 2× 2 Factorial Randomized Clinical Trial
Supratentorial craniotomy is one of the most common neurosurgical procedures, with severe perioperative pain. Inadequate perioperative pain relief has been associated with increased blood pressure and intracranial pressure, favoring bleeding and cerebral cerebral hypoperfusion. The ideal analgesia for neurosurgery requires complete pain relief, eliminates the side effects of opioid drugs and no influence for neurological function. Previous studies have proposed a multimodal analgesic strategy, combining analgesics and local anaesthesia, it is expected to achieve the above benefits.
Read the detailed description
The trial has been designed to analyze the efficacy of local analgesic techniques and dexmedetomidine in the treatment of postoperative acute pain in craniotomy. This randomized clinical trial aims to enroll 2000 patients, which will be randomized to one of 4 groups.
- Conditions
- Postoperative Pain, Analgesia, Supratentorial Brain Tumor
- Being tested
- Dexmedetomidine, Normal saline, Local analgesic techniques, no Local analgesic techniques
- Keywords
- multimodal analgesia, Postoperative acute pain
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called DEX
The 200ug dexmedetomidine will be diluted into a 50ml syringe and administered with 0.4ug/kg/h intraoperatively and 0.05 μg/kg/h for 48 hours after surgery.
Normal salineDrug
Also called NS
In the placebo group, the 0.9% saline is administered with the same volume at the same speed as the dexmedetomidine group
Local analgesic techniquesOther
Also called LAT
As for scalp nerve block, each nerve will be blocked separately with 1-2 mL of 0.67 % liposomal bupivacaine
no Local analgesic techniquesOther
Also called NLAT
No Local analgesic techniques will be given.
| Study group | Role | What they receive |
|---|---|---|
| Local analgesic techniques + dexmedetomidine group | Experimental | The patients in this group will be received scalp nerve block before surgery with 0.67 % liposomal bupivacaine. The patients also will be given dexmedetomidine intravenously at a rate of 0.4 μg/kg/h from skin incision until the beginning of dura mater closure, and will be adjusted to 0.05 μg/kg/h for 48 hours after surgery. Receives: Drug: Dexmedetomidine; Other: Local analgesic techniques |
| Local analgesic techniques and placebo dexmedetomidine group | Experimental | The patients in this group will be received scalp nerve block before surgery with 0.67 % liposomal bupivacaine. For dexmedetomidine placebo group, normal saline will be infused at the same rate as dexmedetomidine during surgery and for 48 hours after surgery. Receives: Drug: Normal saline; Other: Local analgesic techniques |
| Placebo local analgesic techniques and dexmedetomidine group | Experimental | The patients in this group will not receive scalp nerve block. The patients will be given dexmedetomidine intravenously at a rate of 0.4 μg/kg/h from skin incision until the beginning of dura mater closure, and will be adjusted to 0.05 μg/kg/h for 48 hours after surgery. Receives: Drug: Dexmedetomidine; Other: no Local analgesic techniques |
| Placebo local analgesic techniques and placebo dexmedetomidine group | Placebo comparator | The patients in this group will not receive scalp nerve block before surgery . For dexmedetomidine placebo group, normal saline will be infused at the same rate as dexmedetomidine group during surgery and for 48 hours after surgery. Receives: Drug: Normal saline; Other: no Local analgesic techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative amount of sufentanil used by patient-controlled analgesia (PCIA) in patients within 48 hours postoperatively.
Cumulative amount of sufentanil used by patient-controlled analgesia (PCIA) in patients within 48 hours postoperatively.
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 posted9 May 2024
- Study start9 Feb 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuming Peng, Beijing Tiantan Hospital
- Investigators
- Yuming Peng, Dr, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406829
- Sponsor's protocol ID
- 2024007
- Status last verified
- Feb 2026
- First submitted
- 6 May 2024
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Multimodal Analgesia Protocol for Supratentorial Craniotomy：a 2× 2 Factorial Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06406829
- Acronym / sponsor ID
- 2024007
- Conditions
- Postoperative Pain, Analgesia, Supratentorial Brain Tumor
- Keywords
- multimodal analgesia, Postoperative acute pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 9 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 May 2024 (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.
Supratentorial craniotomy is one of the most common neurosurgical procedures, with severe perioperative pain. Inadequate perioperative pain relief has been associated with increased blood pressure and intracranial pressure, favoring bleeding and cerebral cerebral hypoperfusion. The ideal analgesia for neurosurgery requires complete pain relief, eliminates the side effects of opioid drugs and no influence for neurological function. Previous studies have proposed a multimodal analgesic strategy, combining analgesics and local anaesthesia, it is expected to achieve the above benefits.
Detailed description
The trial has been designed to analyze the efficacy of local analgesic techniques and dexmedetomidine in the treatment of postoperative acute pain in craniotomy. This randomized clinical trial aims to enroll 2000 patients, which will be randomized to one of 4 groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Local analgesic techniques + dexmedetomidine group | Experimental | Drug: Dexmedetomidine, Other: Local analgesic techniquesThe patients in this group will be received scalp nerve block before surgery with 0.67 % liposomal bupivacaine. The patients also will be given dexmedetomidine intravenously at a rate of 0.4 μg/kg/h from skin incision until the beginning of dura mater closure, and will be adjusted to 0.05 μg/kg/h for 48 hours after surgery. |
| Local analgesic techniques and placebo dexmedetomidine group | Experimental | Drug: Normal saline, Other: Local analgesic techniquesThe patients in this group will be received scalp nerve block before surgery with 0.67 % liposomal bupivacaine. For dexmedetomidine placebo group, normal saline will be infused at the same rate as dexmedetomidine during surgery and for 48 hours after surgery. |
| Placebo local analgesic techniques and dexmedetomidine group | Experimental | Drug: Dexmedetomidine, Other: no Local analgesic techniquesThe patients in this group will not receive scalp nerve block. The patients will be given dexmedetomidine intravenously at a rate of 0.4 μg/kg/h from skin incision until the beginning of dura mater closure, and will be adjusted to 0.05 μg/kg/h for 48 hours after surgery. |
| Placebo local analgesic techniques and placebo dexmedetomidine group | Placebo comparator | Drug: Normal saline, Other: no Local analgesic techniquesThe patients in this group will not receive scalp nerve block before surgery . For dexmedetomidine placebo group, normal saline will be infused at the same rate as dexmedetomidine group during surgery and for 48 hours after surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged from 18 to 65 years
- American Society of Anesthesiologists physical status I to III
- Scheduled to undergo elective supratentorial tumor resection
Key exclusion criteria (7 listed)
- Incision-area skin infection
- A history of previous craniotomy
- Allergy to study medications
- A history of preoperative change in consciousness or cognitive function
- Severe hepatic or renal 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 |
|---|---|---|
| DexmedetomidineAlso: DEXThe 200ug dexmedetomidine will be diluted into a 50ml syringe and administered with 0.4ug/kg/h intraoperatively and 0.05 μg/kg/h for 48 hours after surgery. | Drug | Local analgesic techniques + dexmedetomidine group, Placebo local analgesic techniques and dexmedetomidine group |
| Normal salineAlso: NSIn the placebo group, the 0.9% saline is administered with the same volume at the same speed as the dexmedetomidine group | Drug | Local analgesic techniques and placebo dexmedetomidine group, Placebo local analgesic techniques and placebo dexmedetomidine group |
| Local analgesic techniquesAlso: LATAs for scalp nerve block, each nerve will be blocked separately with 1-2 mL of 0.67 % liposomal bupivacaine | Other | Local analgesic techniques + dexmedetomidine group, Local analgesic techniques and placebo dexmedetomidine group |
| no Local analgesic techniquesAlso: NLATNo Local analgesic techniques will be given. | Other | Placebo local analgesic techniques and dexmedetomidine group, Placebo local analgesic techniques and placebo dexmedetomidine group |
Primary outcome
Cumulative amount of sufentanil used by patient-controlled analgesia (PCIA) in patients within 48 hours postoperatively.
Time frame: 48 hours postoperatively
Cumulative amount of sufentanil used by patient-controlled analgesia (PCIA) in patients within 48 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 11 Feb 2026.
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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.
Yuming Peng, Dr principal investigator
Beijing Tiantan Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine, Normal saline and Local analgesic techniques in people with Postoperative Pain and Analgesia, run by Beijing Tiantan Hospital.
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 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: opening soon, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Yuming Peng, Dr (8610-59976658, florapym766@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative amount of sufentanil used by patient-controlled analgesia (PCIA) in patients within 48 hours postoperatively. (time frame: 48 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 11 Feb 2026.