Postoperative Analgesia With Liposomal Bupivacaine Versus Standard Bupivacaine Combined With Dexamethasone

Liver Cancer Clinical Trial

Official title:

Thoracic Paravertebral Block With Liposomal Bupivacaine Versus Standard Bupivacaine Combined With Dexamethasone for Postoperative Analgesia in Patients Undergoing Liver Resection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06173466
• Other study ID #: IRB-2023-941 (IIT)
• Status: Recruiting
• Phase: Phase 4
• Start date: December 15, 2023
• Est. completion date: May 29, 2024

Study information

• Verified date: April 2024
• Source: Zhejiang Cancer Hospital
• Contact: Ji Zhu, Ph. D
• Phone: +86 571-88122564
• Email: ec[@]zjcc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: May 29, 2024
• Est. primary completion date: May 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative opioid consumption of 72 hours after surgery	Cumulative opioid consumption of 72 hours after surgery were recorded	From discharge of PACU to 72 hours postoperatively
Secondary	Quality of recovery 40 (QoR-40) score of 72 hours	Quality of recovery 40 (QoR-40) score of 72 hours were recorded. In specific, QoR-40, a 40-item questionnaire that provides a global score and subscores across five dimensions: patient support, comfort, emotions, physical independence, and pain. Each item is graded on a five-point Likert scale. QoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).	From discharge of PACU to 72 hours postoperatively
Secondary	Pain visual analog (VAS) score from 6 hours to 3 months	Pain visual analog (VAS) score from 6 hours to 3 months were recorded. With a sale between 0 to 10, and the pain intensity increases as the number grows. In which 0 represent no pain and 10 represent worst pain.	from 6 hours to 3 months
Secondary	Sleep quality	Sleep quality up to 3 months were recorded. Pittsburgh Sleep Quality Index (PSQI) to assess sleep quality. The PSQI is a validated, self-administered questionnaire used to generate seven component scores calculated by 19 items which reflect subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime function. articipants with poor sleep quality are defined as those with a sum of the scores greater than 5 for these seven components.	From discharge of hospital 6 hours to 3 months