Liposomal Bupivacaine for Postoperative Pain After Craniotomy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBeijing Tiantan Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

106 Participants
are divided into 2 treatment groups
Group A: Liposome bupivacaine groupExperimental treatment 1 intervention
Group B: Ropivacaine groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time of first incision pain within 72 hours after surgery

Time frame
72 hours after surgery

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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