Liposome BupivacaineNCT06701539
Liposomal Bupivacaine for Postoperative Pain After Craniotomy
A study testing Liposome bupivacaine group and Ropivacaine group in people with Liposome Bupivacaine, run by Beijing Tiantan Hospital.
Trial summary
Acute postoperative pain is a common postoperative adverse reaction. It refers to acute pain that occurs immediately after surgery and usually lasts no longer than 3-7. Among the craniotomy approaches, patients undergoing supratentorial craniotomy with temporal approach had a higher incidence of moderate to severe… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liposome Bupivacaine
- What is being tested?
- Liposome bupivacaine group and Ropivacaine group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 31 Dec 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 18-65 years old;
- Patients undergoing craniotomy tumor resection via frontotemporal approach, temporal base approach or temporal occipital approach;
- ASA grade I ~ III;
- Sign informed consent.
Who cannot join
- Previous history of combined drug allergy;
- Patients with a history of severe chronic pain;
- Long-term history of analgesic drug use;
- Patients with aphasia and other inability to cooperate with the scale were evaluated;
- Patients with mental system diseases;
- Patients with incomplete function of vital organs (heart, lung, liver, kidney);
Show all 9Show fewer
- History of drug and drug abuse;
- BMI≥35kg/m2;
- Pregnant or lactating patients.
About this study
Official title: Effect of Nerve Block With Liposome Bupivacaine for Postoperative Pain After Craniotomy: A Randomized Control Trial
Acute postoperative pain is a common postoperative adverse reaction. It refers to acute pain that occurs immediately after surgery and usually lasts no longer than 3-7. Among the craniotomy approaches, patients undergoing supratentorial craniotomy with temporal approach had a higher incidence of moderate to severe pain within 24 hours. In the management of postoperative acute pain, multimodal analgesia is recommended. Liposomal bupivacaine was encapsulated by liposomal vesicles and released slowly, lasting up to 72 hours. The long action time also makes the time window of postoperative acute pain completely covered, thus helping patients better control pain. At present, there is an obvious lack of clinical studies on the effectiveness and specific duration of liposome bupivacaine for postoperative acute pain, especially in neurosurgical craniotomy population with transtemporal incision approach, which is a high-risk group for postoperative pain in neurosurgery.
- Conditions
- Liposome Bupivacaine
- Being tested
- Liposome bupivacaine group, Ropivacaine group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposome bupivacaine groupDrug
After standardized anesthesia induction, bilateral scalp nerve block (supprorbital nerve, auriculotemporal nerve, major occipital nerve, minor occipital nerve) was performed with liposome bupivacaine stock solution, and 1-2ml was injected into each block site.
Ropivacaine groupDrug
After standardized anesthesia induction, bilateral scalp nerve block (supraorbital nerve, auriculotemporal nerve, major occipital nerve, minor occipital nerve) was administered with 0.5% ropivacaine, and 1-2ml was injected into each block site.
| Study group | Role | What they receive |
|---|---|---|
| Liposome bupivacaine group | Experimental | Not described Receives: Drug: Liposome bupivacaine group |
| Ropivacaine group | Active comparator | Not described Receives: Drug: Ropivacaine group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of first incision pain within 72 hours after surgery
Measured: 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liposome BupivacaineStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruquan Han, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06701539
- Sponsor's protocol ID
- Libu20241120
- Status last verified
- Dec 2024
- First submitted
- 20 Nov 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nerve Block With Liposome Bupivacaine for Postoperative Pain After Craniotomy: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06701539
- Acronym / sponsor ID
- Libu20241120
- Conditions
- Liposome Bupivacaine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Nov 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.
Acute postoperative pain is a common postoperative adverse reaction. It refers to acute pain that occurs immediately after surgery and usually lasts no longer than 3-7. Among the craniotomy approaches, patients undergoing supratentorial craniotomy with temporal approach had a higher incidence of moderate to severe pain within 24 hours. In the management of postoperative acute pain, multimodal analgesia is recommended. Liposomal bupivacaine was encapsulated by liposomal vesicles and released slowly, lasting up to 72 hours. The long action time also makes the time window of postoperative acute pain completely covered, thus helping patients better control pain. At present, there is an obvious lack of clinical studies on the effectiveness and specific duration of liposome bupivacaine for postoperative acute pain, especially in neurosurgical craniotomy population with transtemporal incision approach, which is a high-risk group for postoperative pain in neurosurgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposome bupivacaine group | Experimental | Drug: Liposome bupivacaine group |
| Ropivacaine group | Active comparator | Drug: Ropivacaine group |
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 18-65 years old;
- Patients undergoing craniotomy tumor resection via frontotemporal approach, temporal base approach or temporal occipital approach;
- ASA grade I ~ III;
- Sign informed consent.
Key exclusion criteria (9 listed)
- Previous history of combined drug allergy;
- Patients with a history of severe chronic pain;
- Long-term history of analgesic drug use;
- Patients with aphasia and other inability to cooperate with the scale were evaluated;
- Patients with mental system diseases;
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 |
|---|---|---|
| Liposome bupivacaine groupAfter standardized anesthesia induction, bilateral scalp nerve block (supprorbital nerve, auriculotemporal nerve, major occipital nerve, minor occipital nerve) was performed with liposome bupivacaine stock solution, and 1-2ml was injected into each block site. | Drug | Liposome bupivacaine group |
| Ropivacaine groupAfter standardized anesthesia induction, bilateral scalp nerve block (supraorbital nerve, auriculotemporal nerve, major occipital nerve, minor occipital nerve) was administered with 0.5% ropivacaine, and 1-2ml was injected into each block site. | Drug | Ropivacaine group |
Primary outcome
Time of first incision pain within 72 hours after surgery
Time frame: 72 hours after surgery
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 12 Dec 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Liposome bupivacaine group and Ropivacaine group in people with Liposome Bupivacaine, 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 4 inclusion and 9 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 12 Dec 2024. 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. 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?
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?
Time of first incision pain within 72 hours after surgery (time frame: 72 hours after surgery). 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 12 Dec 2024.