Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06173466
Status:
COMPLETED
Last Update Posted:
2024-04-11
First Post:
2023-11-30
Brief Title:
Postoperative Analgesia With Liposomal Bupivacaine Versus Standard Bupivacaine Combined With Dexamethasone
Sponsor:
Zhejiang Cancer Hospital
Organization:
Zhejiang Cancer Hospital
Study Overview
Official Title:
Thoracic Paravertebral Block With Liposomal Bupivacaine Versus Standard Bupivacaine Combined With Dexamethasone for Postoperative Analgesia in Patients Undergoing Liver Resection
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 05 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 75 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
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 05 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 75 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None