Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
Jinan, Shandong, 250014, China
Location status: Recruiting
Location contact
yong T Sun
CONTACT
yong T Sun, PH.D
CONTACT
NCT Number: NCT06165991
I. Research purpose
1.1 Main Objective: To investigate the efficacy and safety of bupivacaine liposome thoracic paravertebral nerve block for postoperative analgesia after thoracoscopic lobectomy
1.2 Exploratory Objective: To investigate the noninferiority of bupivacaine liposomes in thoracic paravertebral nerve block with standard bupivacaine
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
Jinan, Shandong, 250014, China
Location status: Recruiting
yong T Sun
CONTACT
yong T Sun, PH.D
CONTACT
Standard monitoring, including electrocardiography (ECG), heart rate (HR), noninvasive blood pressure (NIBP), pulse oxygen saturation (SpO2), end-tidal carbon dioxide (ETCo2), and bispectral index (BIS) was initiated on arrival in the operating room. A neuromuscular monitor (JS-100, Beijing SLGO Medical Technology Co., Ltd., China) was used to confirm neuromuscular block (NMB).
Intravenous anesthesia was induced with 0.04 mg/kg midazolam, 0.3-0.5 μg/kg sufentanil, 1.5-2.5 mg/kg propofol, and 0.6 mg/kg rocuronium. Hemodynamics were supported with vasoactive agents (atropine, norepinephrine, dopamine, esmolol) as needed. After the train of four count (TOFC) ratio reached zero, a double-lumen tube or a single-lumen tube with a bronchial blocker was inserted, with correct positioning confirmed by fiberoptic bronchoscopy. Under real-time ultrasound visualization, a senior anesthesiologist performed thoracic paravertebral blocks at the T4-5, T6-7, and T8-9 levels in patients placed in the lateral decubitus position, injecting 6 mL, 8 mL, and 6 mL of local anesthetic at the respective levels.
Group B : Patients in the intervention group received a mixture of 10 mL of 1.33% liposomal bupivacaine (133 mg) and 10 mL of 0.5% bupivacaine hydrochloride,.
Group A: whereas those in the control group received 20 mL of 0.5% bupivacaine hydrochloride (total dose, 100 mg).
All patients received total intravenous anesthesia during surgery. Propofol was administered at a rate of 2-4 mg/kg/h, and remifentanil was administered at a rate of 0.05-0.3 μg/kg/min to maintain a BIS value range from 40 to 60. Rocuronium will be administered and adjusted to achieve deep NMB (defined as a TOFC=0 and a post-tetanic count =1-2). Standard ventilation parameters included a respiratory rate of 10-12 breaths·min-¹ and a positive end-expiratory pressure (PEEP) of 5cmH₂O. During double-lung ventilation, a tidal volume of 8 mL/kg was used, with ETCo2 maintained between 35-45 mmHg and peak airway pressure kept below 20cmH₂O. During single-lung ventilation, the tidal volume was reduced to 6 mL/kg, with ETCo2 maintained below 60 mmHg and peak airway pressure kept below 30cmH₂O. Intravenous sufentanil (0.15 μg/kg) and ondansetron hydrochloride (8mg) were administered prior to the end of surgery. After surgery, patients were transferred to the post-anesthesia care unit (PACU) for further monitoring. Additionally, 2-4 mg/kg of sugammadex was given to reverse the residual effect of rocuronium.
In the PACU, an intravenous bolus of 0.1 μg/kg sufentanil was administered when the numeric rating scale (NRS; 0, no pain; 1-3, mild pain; 4-6, moderate pain; and 7-10, severe pain) score was ≥4. The drugs used for postoperative patient-controlled intravenous analgesia (PCIA) were sufentanil (2 μg/kg), which were diluted in 0.9% normal saline to a final volume of 100mL. The analgesia pump settings were as follows: background dose, 0 mL/h; self-controlled additional dose, 1 mL/time; and lockout time, 10 min. The patients were sent to the ward upon meeting the following criteria for at least 30 minutes: NRS score <4, an Adrelete score ≥9 and absence of other adverse reactions. The number of PCA attempts and the total drug delivery were automatically recorded by the postoperative analgesia system.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
TBIL≥1.5×ULN;
Group B::Patients in the intervention group received a mixture of 10 mL of 1.33% liposomal bupivacaine (133 mg) and 10 mL of 0.5% bupivacaine hydrochloride.
Group A:Patients in the control group received 20 mL of 0.5% bupivacaine hydrochloride (total dose, 100 mg).
Time frame: 48hours postoperative
area under the NRS score curve (AUC) for resting and active 48 hours after surgery
Time frame: at 24, 48, and 72 hours after surgery
15 quality of recovery assessments (QoR15) at 24, 48, and 72 hours after surgery. Its scores range from 0 to 150, with higher scores indicating better recovery.Based on the scores, QoR can be classified into excellent (QoR-15 > 135), good (122 ≤ QoR-15 ≤ 135), moderate (90 ≤ QoR-15 ≤ 121), and poor (QoR-15 <90).
Time frame: 48 hours after surgery
area under the NRS score curve (AUC) for resting and exercise 48 hours after surgery
Time frame: 72 hours after surgery
area under the NRS score curve (AUC) for exercise 72 hours after surgery
Time frame: 96 hours after surgery
area under the NRS score curve (AUC) for resting and exercise 96 hours after surgery
Time frame: at 72 hours after surgery
cumulative opioid consumption at 72 hours after surgery (morphine milligram equivalent, MME
Contact information is provided by the study sponsor or research team.
jian bo Wu, PH.D
CONTACT
yong t Sun, PH.D
CONTACT
Yongtao Sun
Other
The Effect of Bupivacaine Liposome Combined With Bupivacaine Hydrochloride on Thoracic Paravertebral Nerve Block for Postoperative Pain After Thoracoscopic Lung Surgery
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