Jiangling Wang
Hangzhou, Zhejiang, 310022, China
Location status: Recruiting
Location contact
Jiangling Wang, Dr.
CONTACT
Jiangling Wang, Dr.
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06704698
Prevention of postoperative pain is essential for the recovery of esophageal surgery. Epidural analgesia is a traditional and standard perioperative pain management for these patients. Beneficials of epidural analgesia have been widely established. However, there are still several potential disadvantages such as perioperative hypotension, failure of administration, rare but serious neurological complications. Ultrasound-guided regional nerve block has become a widely used technique due to its low degree of trauma and precise target of action. In combined with liposome bupivacaine (LB), a new long-acting local anesthetic, was proven to have a maximum duration of 72 hours, thus improving postoperative analgesia, reducing opioid consumption, and enhancing patient satisfaction. The aim of this study was to evaluate the efficacy of TPVB liposomal bupivacaine (LB) or plane bupivacaine (SB) for Overall Benefit of Analgesic Score (OBAS) after esophageal surgery.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Hangzhou, Zhejiang, 310022, China
Location status: Recruiting
Jiangling Wang, Dr.
CONTACT
Jiangling Wang, Dr.
PRINCIPAL_INVESTIGATOR
After approved by the Ethics Committee of the Cancer Hospital of Zhejiang Province (Approval Number: IRB-2024-1037 (IIT)). This study was registered prior to patient admission. Written informed consent was obtained from all participants. The study is scheduled to run from November 25, 2024, to December 31, 2027. A total of 132 patients with ASA physical status I and III, undergoing thoracoscopic esophagectomy will be included. For patients in the liposomal bupivacaine group, in the left lateral decubitus position, a transversus paravertebral block (TPVB) is performed under ultrasound guidance at the right T4-T5, T7-T8, and bilateral T10-T11 paravertebral spaces, injecting 66.5mg (10 ml) liposomal bupivacaine into each space. Postoperative pain control involves patient-controlled intravenous analgesia (PCIA) with 250 μg sufentanil diluted to a total of 250 ml volume with saline. Background dose of 2-3 mL/h, PCA bolus of 2-4 mL depending on height and weight, lockout interval of 15 minutes, and a maximum dose of 10-15 mL.For the standard control group, a T6-T8 epidural block is administered, with 4-6 mL of 0.25% bupivacaine was applied depend on the height and weight. Postoperative analgesia is managed with patient-controlled epidural analgesia (PCEA), with 141 μg sufentanil and 300 mg bupivacaine hydrochloride diluted to 250 mL. Background dose of 3-6 mL/h, PCA bolus of 3-4 mL, lockout interval of 15 minutes, and a maximum dose of 20 mL.
When a participant's resting VAS score is ≥4 and they request additional pain relief, the first rescue analgesic is a single intravenous dose of acetaminophen or an NSAID (flurbiprofen axetil, 50 mg). For a second rescue, a single intravenous dose of 100 mg tramadol is administered. Additionally, the APS team adjusts the background and bolus doses based on pain relief assessments from the previous 24 hours.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Thoracic paravertebral block with liposomal bupivacaine.
Other names: LB
Epidural block with plane bupivacaine.
Other names: PB (Plane Bupivacaine)
Time frame: 3 days after surgery.
Record pain, dizziness,vomiting, itching, sweating, feeling cold, and analgesic satisfaction in the first 72 hours. The higher scores mean a worse outcome.
Time frame: From start of anesthesia to the end of surgery, an average of 5 hours.
Measure the area under the curve of mean artery pressure.
Time frame: 3 days after surgery.
Record Visual Analog Scale scores after surgery, the scale of scores is from 0 to 10 and higher scores mean a worse outcome.
Time frame: 3 days after surgery.
Record total opioid consumption after surgery.
Time frame: From the end of surgery to discharge of hospital. An average of 10 days.
Record in-hospital stay after surgery.
Time frame: 1 year.
Record 3 months and 12 months Visual Analog Scale Scores after surgery, the scale of scores is from 0 to 10 and higher scores mean a worse outcome.
Contact information is provided by the study sponsor or research team.
Zhejiang Cancer Hospital
Other
Paravertebral Block With Liposomal Bupivacaine and Epidural Block With Plane Bupivacaine for Postoperative Analgesia in Esophageal Surgery: A Randomized, Non-inferiority Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07421427
Amantadine, Duloxetine
Cairo, Egypt
View Trial DetailsNCT04299893
Chemotherapy-induced Peripheral Neuropathy, Mental Disorders
Las Palmas de Gran Canaria, Las Palmas, Spain
View Trial DetailsNCT06884852
Breast Cancer Patients, Mental Disorders
Cairo, Egypt
View Trial DetailsNCT06566664
Agnosia, Mental Disorders
Stanford, California, United States
View Trial Details