Postoperative Analgesia With Liposomal Bupivacaine Versus Standard Bupivacaine Combined With Dexamethasone

NCT ID: NCT06173466

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-15
• Study Completion Date: 2024-05-30

Brief Summary

Liposomal bupivacaine is a novel long-acting local anesthetic approved by the FDA for postoperative analgesia because of its ability to significantly prolong the analgesic effect for up to 72 hours. Up to now, no study has demonstrated the effect of postoperative analgesia with liposomal bupivacaine by thoracic paravertebral block (TPVB). The aim of this study was to evaluate the efficacy of liposomal bupivacaine for pain management and recovery after liver resection.

Methods: 96 patients were involved in this randomized, prospective, single-blind study. Patients with hepatocellular carcinoma who were undergoing liver resection were divided into two groups: liposome bupivacaine group (liposomal bupivacaine 133mg) and standard bupivacaine combined with dexamethasone group (standard bupivacaine 150mg and dexamethasone 5mg). Both groups were applied ultrasound guided TPVB. The primary outcome was the cumulative opioid consumptionfor 72 hours. Secodary outcomes included QoR-40 at 72 hours, pain visual analog scale (VAS) score area under the curve (AUC) from 6 hours to 3 months, sleep quality at 1 month and 3 months postoperatively. Adverse events and serious adverse events 3 months after TPVB were also recorded.

Detailed Description

After approved by the Ethics Committee of Zhejiang Cancer Hospital (approval number IRB-2023-941 (IIT)). The study was registered before patient enrollment in Clinicaltrials. Written informed consent was obtained from all participants. The study was performed anticipated from November 9, 2023 to Dec 31, 2025. 96 adult hepatocellular carcinoma patients aged 18-75 years, ASA physical state I and III, who underwent elective or limited partial hepatectomy without allergy to the study drugs were enrolled in this study.

Basic monitoring such as 3-lead electrocardiogram, pulse oximetry, and noninvasive blood pressure were arranged preoperatively. Patients in the bupivacaine liposome group were treated with liposome bupivacaine 133 mg, and patients in the standard control group were treated with 0.5% bupivacaine hydrochloride 150 mg combined with dexamethasone 4 mg, the volume were expended to 30ml in both groups with normal saline. And ultrasound-guided TPVB was performed at the right T7-8, T8-9, T9-10, and T10-11 paravertebral interval under left lateral decubitus position, with 7.5 ml of medication injected into each paravertebral interval, for a total of 30 ml. Patient-controlled intravenous analgesia (PCIA) was used for postoperative analgesia, with 100mg oxycodone expended to 100ml with normal saline, 6-7ml per press with locked time of 15min and limited consumption of 12-15mg each hour based on the weight and basic situation of patient. Rescue analgesia was administered with flurbiprofenate 50 mg or tramadol 100 mg every 6 h when rest VAS score was ≥4. Cumulative consumption of 72 hours postoperatively was recorded. Quality of recovery 40 (QoR-40) score of 72 hours, pain visual analog (VAS) score from 6 hours to 3 months and sleep quality from discharge to 3 months after surgery were also recorded.

Conditions

Liver Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Liposomal bupivacaine

Patients in the bupivacaine liposomal group were treated with liposome bupivacaine 133 mg under ultrasound-guided TPVB. And ultrasound-guided TPVB was performed at the right T7-8, T8-9, T9-10, and T10-11 paravertebral interval under left lateral decubitus position, with 7.5 ml of medication injected into each paravertebral interval, for a total of 30 ml.

Group Type: EXPERIMENTAL

Liposomal bupivacaine

Intervention Type: DRUG

Liposomal bupivacaine 133mg was injected to paravertebral intervals of right T7/8, T8/9, T9//10, T10/11 via ultrasound-guided TPVB

Standard bupivacaine combined with dexamethasone

Patients in the standard control group were treated with 0.5% bupivacaine hydrochloride 150 mg combined with dexamethasone 4 mg. the volume were expended to 30ml in both groups with normal saline. And ultrasound-guided TPVB was performed at the right T7-8, T8-9, T9-10, and T10-11 paravertebral interval under left lateral decubitus position, with 7.5 ml of medication injected into each paravertebral interval, for a total of 30 ml.

Group Type: ACTIVE_COMPARATOR

Bupivacaine Hydrochloride combined with dexamethasone

Intervention Type: DRUG

Standard bupivacaine combined with dexamethasone 4mg was injected to paravertebral intervals of right T7/8, T8/9, T9//10, T10/11 via ultrasound-guided TPVB

Interventions

Liposomal bupivacaine

Liposomal bupivacaine 133mg was injected to paravertebral intervals of right T7/8, T8/9, T9//10, T10/11 via ultrasound-guided TPVB

Intervention Type: DRUG

Bupivacaine Hydrochloride combined with dexamethasone

Standard bupivacaine combined with dexamethasone 4mg was injected to paravertebral intervals of right T7/8, T8/9, T9//10, T10/11 via ultrasound-guided TPVB

Intervention Type: DRUG

Other Intervention Names

LB group (experimental group); SB Group (control group)

Eligibility Criteria

Inclusion Criteria

• 18-75 years old;
• American Society of Anesthesiologist physical status I-III;
• Child-Pugh score A-B;
• Non anergic to medication used in this study;
• Optional/scheduled for liver resection;
• Approved participation before study.

Exclusion Criteria

• Patients with contraindications for local nerve block such as spinal anatomic structure abnormality or local infection of puncture area;
• Anergic to medications used in this study;
• Patient have chronic pain;
• Patient receiving anticoagulants, opioids or have a history of narcotic abuse or alcohol abuse;
• Unable to complete postoperative pain score assessment or questionnaires or have mental disorders;
• Pregnant;
• BMI ≥30 kg/m2;
• Patient involving in other studies.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wang Jiangling

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jiangling Wang, Ph. D

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Cancer Hospital

Locations

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

IRB-2023-941 (IIT)

Identifier Type: -

Identifier Source: org_study_id