Thoracic Paravertebral Block With Liposomal Bupivacaine Versus Standard Bupivacaine Combined With Dexamethasone for Postoperative Analgesia in Patients Undergoing Liver Resection
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Cumulative opioid consumption of 72 hours after surgery
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Patient were performed TPVB in preoperative room before surgery. And the patient, care provider, anesthesiologist in OR, investigator and outcome assessor were blind to the study group.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Liposomal bupivacaine (Drug)
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.
干预措施: Bupivacaine Hydrochloride combined with dexamethasone (Drug)
结局指标
主要结局
Cumulative opioid consumption of 72 hours after surgery
时间窗: From discharge from post anesthesia care unit (PACU) to 72 hours postoperatively.
Cumulative opioid consumption of 72 hours after surgery were recorded.
次要结局
- Quality of recovery 40 (QoR-40) scores of 72 hours(From discharge from PACU to 72 hours postoperatively.)
- Pain visual analog (VAS) scores from 6 hours to 3 months(From 6 hours to 3 months after surgery.)
- Sleep quality(3 months after surgery.)
- Time to first opioid use(An average time is 2-3 hours after discharge from PACU.)
- Plasma bupivacaine concentration(From 30 minutes after local anesthetics administration to 72 hour after surgery.)
- Postoperative plasma inflammatory factors(From administration of local anesthesics to 72 hour after surgery.)
研究者
Wang Jiangling
Principal Investigator
Zhejiang Cancer Hospital