Thoracic Surgery Intercostal Block Trial With Liposomal vs. Hydrochloride Bupivacaine

Recruiting · NCT07134660 · Interventional (participants receive a specific treatment) · Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China

View the official record on ClinicalTrials.gov →

Lung Cancer

Interventions studied

Bupivacaine Hydrochloride intercostal nerve blockLiposomal Bupivacaine intercostal nerve blockStandard Postoperative Analgesia

What this trial is about

This randomized controlled trial evaluates the analgesic effects of liposomal bupivacaine compared to bupivacaine hydrochloride in intercostal nerve block for patients undergoing thoracoscopic lung surgery. Postoperative pain remains a significant issue in thoracic procedures, often leading to complications like pneumonia or delayed recovery. The investigators hypothesize that liposomal bupivacaine, with its extended-release properties, will provide superior pain relief beyond 24 hours compared to standard bupivacaine or no block. Participants will be randomized 1:1:1 to liposomal bupivacaine group , bupivacaine hydrochloride group , or control group . Primary outcome is the area under the curve of pain scores from 25-72 hours post-surgery. Secondary outcomes include opioid consumption, recovery quality (QoR-15), and other complications.

Who can take part

Age range

18 Years to 80 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

Inclusion criteria

Scheduled for elective unilateral thoracoscopic (VATS) lung surgery
Age 18 to 80 years
American Society of Anesthesiologists (ASA) physical status I-III

Exclusion criteria

Contraindication to local anesthetics (infection at puncture site, allergy to local anesthetics, coagulopathy or other bleeding risk)
Sensory abnormalities in the planned chest-wall surgical area
Hepatic dysfunction (ALT \> 50 U/L, AST \> 40 U/L, or total bilirubin ≥ 19 μmol/L) or renal dysfunction (serum creatinine \> 112 μmol/L, BUN \> 7.1 mmol/L, or dialysis within 28 days before surgery)
Pregnancy, breastfeeding, women of childbearing potential not using adequate contraception, or planning pregnancy during the study period
Preoperative opioid use, history of chronic pain, or history of opioid abuse
Refusal to provide informed consent

Where it is running

1 location listed.

Shanghai pulmonary hospital - Shanghai, China

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →