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A multicenter, randomized, non-inferiority study of bupivacaine liposome versus conventional bupivacaine combined with dexmedetomidine for rhomboid intercostal-lower serratus anterior nerve block in postoperative analgesia after thoracoscopy

A multicenter, randomized, non-inferiority study of bupivacaine liposome versus conventional bupivacaine combined with dexmedetomidine for rhomboid intercostal-lower serratus anterior nerve block in postoperative analgesia after thoracoscopy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123335
Enrollment
Unknown
Registered
2026-04-24
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with lung cancer in the thoracic department

Interventions

Plain bupivacaine with dexmedetomidine group:Administer 105 mg of plain bupivacaine + 0.5 µg/kg of dexmedetomidine
Liposomal bupivacaine group:Administer 93 mg of bupivacaine liposome + 25 mg of regular bupivacaine.

Sponsors

The First Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Eligible participants are adults aged between 18 and 80 years old with American Society of Anesthesiologists (ASA) physical status classification of I to III. 2. All patients are scheduled to undergo elective thoracoscopic lung resection surgery, including wedge resection, segmentectomy or lobectomy, under general anesthesia, with either single-port or three-port approach, and the estimated operation time does not exceed 4 hours. 3. Participants are required to have a body mass index (BMI) between 18 and 30 kg/m^2.

Exclusion criteria

Exclusion criteria: 1. Heart failure with NYHA functional class III or IV who are scheduled to undergo trauma-related or emergency surgery; 2. Unstable coronary artery disease; severe renal impairment (estimated glomerular filtration rate < 30 ml/min/1.73 m²); significant liver function abnormalities (alanine aminotransferase or aspartate aminotransferase levels more than twice the upper limit of normal); 3. Presence of coagulation disorders or failure to discontinue anticoagulant drugs (such as warfarin, rivaroxaban, dabigatran, etc.) in accordance with institutional perioperative management guidelines; 4. Chronic pain syndrome (such as complex regional pain syndrome, reflex sympathetic dystrophy) or long-term use of opioids (defined as continuous use for more than 3 months, or daily oral morphine equivalent dose exceeding 5 mg for at least 1 month); 5. Current or within the last 2 months, history of alcohol abuse; uncontrolled mental illness (such as schizophrenia, severe anxiety disorder); 6. Known allergy to amide-type local anesthetics or any drug involved in the study; 7. Presence of contraindications to study drugs; 8. Pregnant or lactating women, and those planning to become pregnant during the study period; 9. Inability or refusal to sign the written informed consent form.

Design outcomes

Primary

MeasureTime frame
The area under the curve (AUC) of the numeric rating scale (NRS) pain score at rest 48 hours after surgery;

Secondary

MeasureTime frame
The NRS scores at multiple time points within 72 hours after surgery ;The indicators related to functional recovery include the volume of thoracic drainage fluid, the time of chest tube removal, the length of stay in the Post-Anesthesia Care Unit (PACU);The occurrence of postoperative pulmonary complications (PPCs) ;Other postoperative complications were also monitored and recorded. Including New-onset atrial fibrillation (NOAF), severe ventricular arrhythmia, and deep venous thrombosis (DVT) DVT, pulmonary embolism (PE) and intestinal obstruction. ;Postoperative sufentanil consumption;The time of first getting out of bed for activity and the frequency of rescue analgesia use.;The quality of postoperative recovery was evaluated using the validated Recovery Quality-40 scale.;Preoperative baseline, postoperative day 1 (POD-1), and postoperative day 2 (POD-2).;Postoperative nausea and vomiting;Systemic inflammatory response was evaluated by measuring C-reactive protein (CRP) on the day before surgery (i.e., one day before the operation), and by determining the levels of CRP, procalcitonin (PCT), and interleukin-6 (IL-6) on the first postoperative day.;

Countries

China

Contacts

Public ContactWei Deng

The First Affiliated Hospital of Nanchang University

ndyfy07282@ncu.edu.cn+86 136 8709 5656

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026