Postoperative Analgesia Between Paravertebral Block and Epidural Block in Esophageal Surgery

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

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.

Study Overview

• Status: Recruiting
• Conditions: Vomiting; Satisfaction, Patient; Dizziness; Itching; Pain Syndrome; Cold; Sweet Syndrome
• Intervention / Treatment: Drug: Liposomal bupivacaine; Drug: Bupivacaine Hydrochloride

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.

• Study Type: Interventional
• Enrollment (Estimated): 132
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiangling Wang, M.D; Phone Number: +8615168373331; Email: wangjl@zjcc.org.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Recruiting
      • Jiangling Wang
      • Principal Investigator: Jiangling Wang, Dr.
      • Contact: Jiangling Wang, Dr.; Phone Number: +8615168373331; Email: wangjl@zjcc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thoracic paravertebral block; Ultrasound guided paravertebral block (TPVB) with liposomal bupivacaine is performed in this group. 40ml of liposomal bupivacaine and saline mixture was injected to the right T4-T5, T7-T8, and bilateral T10-T11 paravertebral spaces, with 10 ml for each space. Patient-controlled intravenous analgesia (PCIA) is used for postoperative pain management.	Drug: Liposomal bupivacaine; Thoracic paravertebral block with liposomal bupivacaine.; Other Names: LB
Other: Epidural block; For the standard control group, a T6-T8 epidural block is administered. Postoperative analgesia is managed with patient-controlled epidural analgesia (PCEA).	Drug: Bupivacaine Hydrochloride; Epidural block with plane bupivacaine.; Other Names: PB (Plane Bupivacaine)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Benefit of Analgesic Score (OBAS)	Record pain, dizziness,vomiting, itching, sweating, feeling cold, and analgesic satisfaction in the first 72 hours. The higher scores mean a worse outcome.	3 days after surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the curve of mean artery pressure (MAP < 65 mmHg)	Measure the area under the curve of mean artery pressure.	From start of anesthesia to the end of surgery, an average of 5 hours.
Visual Analog Scale (VAS)	Record Visual Analog Scale scores after surgery, the scale of scores is from 0 to 10 and higher scores mean a worse outcome.	3 days after surgery.
Total opioid consumption	Record total opioid consumption after surgery.	3 days after surgery.
In-hospital stay	Record in-hospital stay after surgery.	From the end of surgery to discharge of hospital. An average of 10 days.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long time Visual Analog Scale (VAS) after surgery	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.	1 year.

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital
• Investigators: Principal Investigator: Jiangling Wang, Ph.D, Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2024
• Primary Completion (Estimated): December 25, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: November 18, 2024
• First Submitted That Met QC Criteria: November 21, 2024
• First Posted (Actual): November 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathologic Processes; Signs and Symptoms, Digestive; Disease; Skin Diseases; Sensation Disorders; Erythema; Syndrome; Vomiting; Dizziness; Sweet Syndrome; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Bupivacaine
• Other Study ID Numbers: IRB-2024-1037（IIT）

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study plan is available when required to the principal investigator.
• IPD Sharing Time Frame: From the study ended to the published
• IPD Sharing Access Criteria: Doctors or healthy providers only.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No