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Not yet recruitingNCT06701539Updated Dec 12, 2024

Liposomal Bupivacaine for Postoperative Pain After Craniotomy

An interventional study of Liposome bupivacaine group and Ropivacaine group in Liposome Bupivacaine, sponsored by Beijing Tiantan Hospital. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-12-12.

Sponsored by Beijing Tiantan Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
106
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Liposome Bupivacaine

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03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's planned enrollment of 106 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Beijing Tiantan Hospital is the lead sponsor of 465 studies on the registry; 282 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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);
  • History of drug and drug abuse;
  • BMI≥35kg/m2;
  • Pregnant or lactating patients.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
106 participants (estimated)

Study arms

  • Experimental
    Liposome bupivacaine group

    Drug: Liposome bupivacaine group

  • Active comparator
    Ropivacaine group

    Drug: Ropivacaine group

Interventions

  • DrugLiposome bupivacaine group

    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.

  • DrugRopivacaine group

    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.

06

What researchers measure

Primary outcomes

  1. Time of first incision pain within 72 hours after surgery

    Time frame: 72 hours after surgery

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Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06701539
Lead sponsor
Beijing Tiantan Hospital
Responsible party
Ruquan Han (Head of Anesthesiology, Beijing Tiantan Hospital) — Principal investigator
First posted
Nov 22, 2024
Start date
Dec 1, 2024 (estimated)
Primary completion
Jun 1, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Dec 12, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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