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Liposomal Bupivacaine for Postoperative Pain After Craniotomy

Capital Medical University logo

Capital Medical University

Status

Not yet enrolling

Conditions

Liposome Bupivacaine

Treatments

Drug: Ropivacaine group
Drug: Liposome bupivacaine group

Study type

Interventional

Funder types

Other

Identifiers

NCT06701539
Libu20241120

Details and patient eligibility

About

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.

Enrollment

106 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

106 participants in 2 patient groups

Liposome bupivacaine group
Experimental group
Treatment:
Drug: Liposome bupivacaine group
Ropivacaine group
Active Comparator group
Treatment:
Drug: Ropivacaine group

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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