Postoperative Analgesia Between Paravertebral Block and Epidural Block in Esophageal Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Liposomal bupivacaine, Bupivacaine Hydrochloride.
- Who it may be relevant to
- Registry conditions: Pain Syndrome, Dizziness, Vomiting, Itching. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Paravertebral Block With Liposomal Bupivacaine and Epidural Block With Plane Bupivacaine for Postoperative Analgesia in Esophageal Surgery: A Randomized, Non-inferiority Study
Overview
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.
Detailed description
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.
Interventions
- Drug Liposomal bupivacaine
Thoracic paravertebral block with liposomal bupivacaine. - Drug Bupivacaine Hydrochloride
Epidural block with plane bupivacaine.
Primary outcome measures
- Overall Benefit of Analgesic Score (OBAS) [Time frame: 3 days after surgery.]
Secondary outcome measures (4)
- Area under the curve of mean artery pressure (MAP < 65 mmHg) [Time frame: From start of anesthesia to the end of surgery, an average of 5 hours.]
- Visual Analog Scale (VAS) [Time frame: 3 days after surgery.]
- Total opioid consumption [Time frame: 3 days after surgery.]
- In-hospital stay [Time frame: From the end of surgery to discharge of hospital. An average of 10 days.]
Eligibility criteria
Inclusion criteria
- American Society of Anesthesiologist physical status I-III;
- Scheduled elective thoracoscopic esophagectomy(three-incision approach);
- 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;
- Inability to complete postoperative pain assessments or questionnaires due to communication barriers or mental disorders;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Jiangling Wang — Hangzhou
Identifiers
NCT: NCT06704698 · IRB-2024-1037（IIT）