Clinical trial NCT06173466: Postoperative Analgesia With Liposomal Bupivacaine Versus Standard Bupivacaine Combined With Dexamethasone
Official title: Thoracic Paravertebral Block With Liposomal Bupivacaine Versus Standard Bupivacaine Combined With Dexamethasone for Postoperative Analgesia in Patients Undergoing Liver Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Liver Cancer
Keywords: Liver Resection
Thoracic Paravertebral Block
Liposomal Bupivacaine
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2023-12-15
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Cumulative opioid consumption of 72 hours after surgery
timeFrame: From discharge from post anesthesia care unit (PACU) to 72 hours postoperatively.
Secondary outcomes:
measure: Quality of recovery 40 (QoR-40) scores of 72 hours
timeFrame: From discharge from PACU to 72 hours postoperatively.
measure: Pain visual analog (VAS) scores from 6 hours to 3 months
timeFrame: From 6 hours to 3 months after surgery.
measure: Sleep quality
timeFrame: 3 months after surgery.
measure: Time to first opioid use
timeFrame: An average time is 2-3 hours after discharge from PACU.
measure: Plasma bupivacaine concentration
timeFrame: From 30 minutes after local anesthetics administration to 72 hour after surgery.
measure: Postoperative plasma inflammatory factors
timeFrame: From administration of local anesthesics to 72 hour after surgery.
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Jiangling Wang, Ph. D
role: PRINCIPAL_INVESTIGATOR
References: