Thoracic Surgery Intercostal Block Trial With Liposomal vs. Hydrochloride Bupivacaine
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Pulmonary Hospital, Shanghai, China
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Scheduled for elective unilateral thoracoscopic (VATS) lung surgery
Age 18 to 80 years
American Society of Anesthesiologists (ASA) physical status I-III
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Liposomal Bupivacaine intercostal nerve block
Procedure/SurgeryUltrasound-guided intercostal nerve block with liposomal bupivacaine 266 mg (20 mL total; 4 mL per intercostal space at the incision and adjacent spaces), performed at the end of surgery before emergence from anesthesia. All patients receive standard postoperative analgesia with intravenous patient-controlled opioid analgesia.
Bupivacaine Hydrochloride intercostal nerve block
Procedure/SurgeryUltrasound-guided intercostal nerve block with 0.25% bupivacaine hydrochloride (20 mL total; 4 mL per intercostal space at the incision and adjacent spaces), performed at the end of surgery before emergence from anesthesia. All patients receive standard postoperative analgesia with intravenous patient-controlled opioid analgesia.
Standard Postoperative Analgesia
Other interventionNo intercostal nerve block. Patients receive standard postoperative analgesia consisting of an intravenous patient-controlled opioid pump per institutional protocol.
Treatment groups
210 Participants
are divided into 3 treatment groupsGroup A: Liposomal Bupivacaine GroupExperimental treatment 1 intervention
Group B: Bupivacaine Hydrochloride GroupActive comparator 1 intervention
Group C: Control Group (Standard Analgesia Only)Sham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pain score area under the curve (AUC) from 25 to 72 hours postoperatively
Area under the curve of postoperative pain intensity measured on the VRS. AUC is computed over the 25-72 h interval. Postoperative pain intensity assessed using the Verbal Response Scale (VRS), the score ranges from 0 to 10, with a total of 11 numbers corresponding to different pain levels: 0 indicates no pain; 1-3 indicates mild pain (tolerable and does not affect sleep); 4-6 indicates moderate pain (significant, affects sleep, and requires medication for relief); and 7-10 indicates severe pain (intense, intolerable, and severely affects life).
Time frame
25 to 72 hours after the end of surgerySecondary outcomes
1
Pain score at PACU discharge and postoperative intervals
Pain intensity assessed using the VRS in the post-anesthesia care unit (PACU) and at 6, 12, 24, 48, and 72 hours after surgery. Postoperative pain intensity assessed using the Verbal Response Scale (VRS), the score ranges from 0 to 10, with a total of 11 numbers corresponding to different pain levels: 0 indicates no pain; 1-3 indicates mild pain (tolerable and does not affect sleep); 4-6 indicates moderate pain (significant, affects sleep, and requires medication for relief); and 7-10 indicates severe pain (intense, intolerable, and severely affects life).Rescue analgesia is provided if VRS \>4.
Time frame
At PACU discharge, and 6, 12, 24, 48, and 72 hours postoperatively2
Cumulative opioid consumption
Total postoperative opioid use converted to morphine milligram equivalents.
Time frame
From the end of surgery to 48 hours after surgeryOther outcomes
1
Duration of chest wall analgesia
Time from performance of the intercostal nerve block (end of surgery) to return of chest-wall sensation, as determined by cold and pinprick testing at predefined chest-wall sites.
Time frame
From intervention (end of surgery) up to 7 days2
Quality of Recovery (QoR-15) score
Measured by the QoR-15 questionnaire (15 items, total score 0-150; higher scores indicate better recovery).
Time frame
24, 48, and 72 hours after surgery3
Incidence of postoperative nausea and vomiting
Number of patients of nausea or vomiting recorded at 24, 48, and 72 hours after surgery.
Time frame
24, 48, and 72 hours postoperatively4
Incidence of postoperative pulmonary complications
Occurrence of postoperative pulmonary complications-including pneumonia, atelectasis, acute respiratory distress syndrome (ARDS), and aspiration-defined by CDC and Berlin criteria.
Time frame
From intervention (end of surgery) up to 7 daysSponsors and contacts
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Source ClinicalTrials.gov