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NCT Number: NCT06701539

Liposomal Bupivacaine for Postoperative Pain After Craniotomy

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.

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Key information

Conditions

Liposome Bupivacaine

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Liposome bupivacaine group

Drug

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 group

Drug

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.

Primary outcomes

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

    Time frame: 72 hours after surgery

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

Effect of Nerve Block With Liposome Bupivacaine for Postoperative Pain After Craniotomy: A Randomized Control Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 22, 2024
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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