The Efficacy and Safety of Liposomal Bupivacaine in Relieving Postoperative Pain After Video-assisted Thoracoscopic Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorBeijing Tiantan Hospital

About this trial

Video-assisted thoracoscopic surgery (VATS) is less invasive compared to traditional thoracotomy. It is reported that the incidence of acute pain following VATS exceeds 80%. Inadequate postoperative analgesia may trigger a series of adverse physiological stress responses, increase the occurrence of postoperative complications, and affect the rehabilitation process.If acute pain is not managed promptly and sufficiently, nearly one-quarter of patients may develop chronic pain, impacting normal life and sleep quality after discharge. Local infiltration anesthesia at the incision site is one of the simplest, safest, and most effective methods for preventing postoperative incision pain. Liposomal bupivacaine(LB) is a novel, long-acting, sustained-release amide-type local anesthetic, providing localized analgesic effects for up to 72 hours. Some researchers have reported the analgesic effects of LB VS traditional local anesthetics infiltration, but the current research results are highly heterogeneous. More prospective studies are needed to evaluate whether LB infiltration is superior to the traditional local anesthetics for the management of postoperative pain. The investigators designed this study to compare the analgesic effect of using LB plus bupivacaine for local infiltration with bupivacaine along for patients after VATS.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients scheduled for elective video-assisted thoracoscopic lobectomy or wedge resection under general anesthesia;

Ages 18 to 64 years old;

American Society of Anesthesiologists (ASA) physical status of I-III;

Glasgow Coma Scale (GCS) score of 15;

Disqualifiers

History of chronic pain syndrome of any cause.

Patients with heart conduction block (sinus block or atrioventricular block).

Patients with unstable coronary artery disease.

Patients with gastric ulcer or gastric bleeding.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bupivacaine hydrochloride

    Drug

    The 40 mL 0.25% Bupivacaine hydrochloride (100 mg, normal saline dilution) for the Bupivacaine hydrochloride group.Local infiltration will be performed by the thoracic surgeon before closure. A total of 30-40 mL of fluid will be injected at the incision.The PCA solution is prepared by diluting 100 μg of sufentanil and 16 mg of ondansetron with normal saline to a total volume of 100 mL. Postoperatively, the patient may press the demand button for analgesia. Each activation delivers a 2 mL bolus, with a lockout interval of 10 minutes.If analgesia remains inadequate after four consecutive demands, one Oxycodone and Acetaminophen Tablets (containing 5 mg oxycodone hydrochloride and 325 mg acetaminophen) is administered orally, with a minimum interval of 6 hours between repeated administrations. If pain persists, intravenous morphine 5 mg may be administered at intervals no shorter than 4 hours.

  • Liposomal bupivacaine plus bupivacaine

    Drug

    The 20 mL (266 mg) of liposomal bupivacaine will be mixed with a volume of 20 mL 0.25% Bupivacaine hydrochloride (50 mg, normal saline dilution) for the Liposomal Bupivacaine plus Bupivacaine hydrochloride group.Local infiltration will be performed by the thoracic surgeon before closure.A total of 30-40 mL of fluid will be injected at the incision.The PCA solution is prepared by diluting 100 μg of sufentanil and 16 mg of ondansetron with normal saline to a total volume of 100 mL. Postoperatively, the patient may press the demand button for analgesia. Each activation delivers a 2 mL bolus, with a lockout interval of 10 minutes.If analgesia remains inadequate after four consecutive demands, one Oxycodone and Acetaminophen Tablets (containing 5 mg oxycodone hydrochloride and 325 mg acetaminophen) is administered orally, with a minimum interval of 6 hours between repeated administrations. If pain persists, intravenous morphine 5 mg may be administered at intervals no shorter than 4 hours.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Bupivacaine hydrochlorideActive comparator 1 intervention
Group B: Liposomal bupivacaine plus bupivacaineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively

Time frame
The postoperative period 48 hours.

Secondary outcomes

1

Area Under the Curve (AUC) of Numeric Rating Scale at rest (NRSr) Within 0-72 Hours Postoperatively

The Numeric Rating Scale (NRS) designates 0 as representing no pain and 10 as representing the most severe pain; scores of 1-3 indicate mild pain, 4-6 denote moderate pain, and 7-10 signify severe pain.

Time frame
Data will be collected at 2 hours, 24 hours, 48 hours, and 72 hours postoperatively.
2

Numeric Rating Scale at rest (NRSr) at 1 week, 1 month, and 3 months postoperatively

The Numeric Rating Scale (NRS) designates 0 as representing no pain and 10 as representing the most severe pain; scores of 1-3 indicate mild pain, 4-6 denote moderate pain, and 7-10 signify severe pain.

Time frame
Postoperative day 7, month 1, and month 3.
3

Time to request of first analgesia

Time frame
Within 48 hours postoperatively.
4

Cumulative sufentanil dose for four separate periods (0-4, 4-8, 8-24, and 24-48 h), a total press count including both valid and invalid presses

Time frame
Postoperative Hours 4, 8, 24, and 48.

Other outcomes

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