Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID06704698

Paravertebral Block With Liposomal Bupivacaine and Epidural Block With Plane Bupivacaine for Postoperative Analgesia in Esophageal Surgery: A Randomized, Non-inferiority Study

Led by Zhejiang Cancer Hospital · Updated on 2024-12-30

132

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating two methods for managing postoperative pain in patients undergoing thoracoscopic esophagectomy: thoracic paravertebral block (TPVB) with liposomal bupivacaine and epidural block with standard bupivacaine. The study aims to compare the overall benefit of analgesic score (OBAS) three days after surgery. This trial addresses the need for effective pain control while considering potential drawbacks of epidural analgesia, such as hypotension and rare neurological complications. Patients will be randomly assigned to one of two groups. The experimental group receives ultrasound-guided TPVB injections of liposomal bupivacaine at multiple thoracic paravertebral spaces, followed by patient-controlled intravenous analgesia (PCIA) using sufentanil. The control group is treated with an epidural block at T6-T8 and patient-controlled epidural analgesia (PCEA) with sufentanil and bupivacaine hydrochloride. Rescue analgesics include acetaminophen or NSAIDs for mild pain and tramadol for more severe pain, with doses adjusted by the acute pain service team. Participants will be closely monitored for pain scores using visual analog scales, opioid consumption, mean arterial pressure, and hospital stay duration. Pain relief assessments and questionnaires are completed during the first three postoperative days. The study is triple-blinded and involves continuous evaluation of safety and analgesic benefit. Total in-hospital monitoring averages about ten days, with follow-up on analgesic outcomes and recovery progress.

CONDITIONS

Brief Title

Postoperative Analgesia Between Paravertebral Block and Epidural Block in Esophageal Surgery

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • American Society of Anesthesiologist physical status I-III
  • Scheduled elective thoracoscopic esophagectomy (three-incision approach)
  • Approved participation before study
Not Eligible

You will not qualify if you...

  • Contraindications for local nerve block such as spinal anatomic structure abnormality or local infection of puncture area
  • Allergy to medications used in this study
  • Chronic pain
  • Receiving anticoagulants, opioids or history of narcotic or alcohol abuse
  • Inability to complete postoperative pain assessments or questionnaires due to communication barriers or mental disorders

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

Duration - Approximately 5 hours

Participants undergo thoracoscopic esophagectomy with either a paravertebral block using liposomal bupivacaine or an epidural block using bupivacaine for postoperative analgesia.

1 surgery and immediate post-operative period

Treatment

Duration - 3 days after surgery

Participants receive postoperative pain management using patient-controlled analgesia: intravenous analgesia for the paravertebral block group or epidural analgesia for the epidural block group. Rescue analgesics are provided as needed based on pain assessments.

Daily pain assessments and analgesic management during hospital stay

Post-operative Follow-up

Duration - Approximately 10 days from end of surgery to hospital discharge

Participants remain hospitalized for monitoring and recovery following surgery and analgesic treatment.

Daily hospital visits for recovery monitoring

Trial Site Locations

Total: 1 location

1

Jiangling Wang

Hangzhou, Zhejiang, China, 310022

Actively Recruiting

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Research Team

J

Jiangling Wang, M.D

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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