Postoperative Analgesia Between Paravertebral Block and Epidural Block in Esophageal Surgery

NCT06704698 | Recruiting

• 1 other identifier: IRB-2024-1037（IIT）
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain Syndrome; Dizziness; Vomiting; Itching; Sweet Syndrome; Cold; Satisfaction, Patient

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Area under the curve of mean artery pressure (MAP < 65 mmHg)

  From start of anesthesia to the end of surgery, an average of 5 hours.

• Visual Analog Scale (VAS)

  3 days after surgery.

• Total opioid consumption

  3 days after surgery.

• In-hospital stay

  From the end of surgery to discharge of hospital. An average of 10 days.

Other Outcomes (1)

• Long time Visual Analog Scale (VAS) after surgery

  1 year.

Study Arms (2)

Thoracic paravertebral block

EXPERIMENTAL

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

Epidural block

OTHER

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

Interventions

Liposomal bupivacaine DRUG

Thoracic paravertebral block with liposomal bupivacaine.

Also known as: LB

Thoracic paravertebral block

Bupivacaine Hydrochloride DRUG

Epidural block with plane bupivacaine.

Also known as: PB (Plane Bupivacaine)

Epidural block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologist physical status I-III;
• Scheduled elective thoracoscopic esophagectomy(three-incision approach);
• Approved participation before study.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Jiangling Wang

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Somatoform Disorders; Dizziness; Vomiting; Pruritus; Sweet Syndrome; Common Cold; Patient Satisfaction

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Mental Disorders; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Erythema; Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Jiangling Wang, Ph.D

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiangling Wang, M.D

CONTACT

+8615168373331; wangjl@zjcc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 26, 2024
• Study Start: December 3, 2024
• Primary Completion: December 25, 2025
• Study Completion: December 30, 2025
• Last Updated: December 30, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: From the study ended to the published
• Access Criteria: Doctors or healthy providers only.

Locations

CN (1)