Comparison of the Ultrasound-guided Paravertebral Nerve Block With Liposomal Bupivacaine Versus Ropivacaine for Post-Surgical Pain After Video-Assisted Thoracoscopic Surgery

Comparison of the Ultrasound-guided Paravertebral Nerve Block With Liposomal Bupivacaine Versus Ropivacaine for Post-Surgical Pain After Video-Assisted Thoracoscopic Surgery:A Single-Center, Prospective, Randomized, and Controlled Trial

Prospective, randomized, and controlled trial to compare the postoperative pain management of paravertebral nerve block with liposomal bupivacaine to ropivacaine in patients undergoing elective thoracoscopic surgery.

Study Overview

• Status: Not yet recruiting
• Conditions: Analgesia
• Intervention / Treatment: Drug: Liposomal bupivacaine; Drug: Ropivacaine

Detailed Description

The objective of this study is to validate the analgesic efficacy of liposomal bupivacaine (LB) compared with ropivacaine when injected for paravertebral nerve block (PVB) for video-assisted thoracoscopic surgery (VATS).

We hypothesize that LB will be superior to ropivacaine in terms of postoperative pain control following VATS. The primary outcome of this study will be NRS pain scores for resting pain and NRS pain scores for cough pain 24 hours following surgery. Secondary outcomes will include pain scores over the first 120 hours following surgery, opioid consumption, opioid-related adverse events, block-related adverse events, time of first getting out of bed, catheter indwelling time, postoperative hospitalization time, patient satisfaction, and chronic pain at 1, 3, and 6 months after surgery.

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Feng Gao, Doctor; Phone Number: 86 13971587381; Email: fgao@tjh.tjmu.edu.cn

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Age 18-64 years old
2. Elective unilateral thoracoscopic surgery
3. Hospital stay ≥3 days
4. Able to cooperate in completing interviews and scale assessments
5. American Society of Anesthesiologists (ASA) classification I-III
6. Signed informed consent form

Exclusion Criteria:

1. History of thoracic surgery within the past 6 months
2. Pre-existing history of chronic pain or acute pain in the surgical area
3. Allergy to local anesthetics
4. Contraindications to thoracic paravertebral nerve block
5. Mental disorders, intellectual disabilities, epilepsy, or other neurological conditions
6. Severe heart or lung diseases
7. History of opioid drug abuse or substance abuse
8. Postoperative intubation
9. Recent participation in other clinical studies

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drug: Liposomal bupivacaine; Experimental group will receive PVB with LB 20 mL.	Drug: Liposomal bupivacaine; 133mg LB 20mL thoracic paravertebral nerve block; Other Names: Exparel
Active Comparator: Drug:ropivacaine; Comparator group will receive PVB with 20 mL of 0.5% ropivacaine	Drug: Ropivacaine; 0.5% ropivacaine 20mL thoracic paravertebral nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain score at rest	The pain score at rest will be assessed using the Numeric Rating Scale (NRS), which ranges from 0 (representing "no pain") to 10 (representing "the worst pain").	24 hours after surgery
pain score during coughing	The pain score during coughing will be assessed using the Numeric Rating Scale (NRS), which ranges from 0 (representing "no pain") to 10 (representing "the worst pain").	24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The douleur neuropathique 4 questionnaire(DN4)	This questionnaire serves as a diagnostic tool for identifying neuropathic pain. It comprises 10 options, consisting of 7 self-assessment items that evaluate symptoms. The total score is 10 points, and a score of ≥ 4 indicates the possibility of neuropathic pain, while a score < 4 rules out neuropathic pain.	day1 before surgery
Mini-cog	The Mini-Cog uses recall and clock-drawing tests to determine whether patients have cognitive impairments. A score of 0-2 indicates a positive dementia screening, while a score of 3-5 implies a negative screening, necessitating further evaluation.	day1 before surgery
pain score at rest	The pain score at rest will be assessed using the Numeric Rating Scale (NRS), which ranges from 0 (representing "no pain") to 10 (representing "the worst pain").	6 hours after surgery
pain score during coughing	The pain score during coughing will be assessed using the Numeric Rating Scale (NRS), which ranges from 0 (representing "no pain") to 10 (representing "the worst pain").	6 hours after surgery
pain score at rest	The pain score at rest will be assessed using the Numeric Rating Scale (NRS), which ranges from 0 (representing "no pain") to 10 (representing "the worst pain").	48 hours after surgery
pain score during coughing	The pain score during coughing will be assessed using the Numeric Rating Scale (NRS), which ranges from 0 (representing "no pain") to 10 (representing "the worst pain").	48 hours after surgery
pain score during coughing	The pain score during coughing will be assessed using the Numeric Rating Scale (NRS), which ranges from 0 (representing "no pain") to 10 (representing "the worst pain").	72 hours after surgery
pain score at rest	The pain score at rest will be assessed using the Numeric Rating Scale (NRS), which ranges from 0 (representing "no pain") to 10 (representing "the worst pain").	72 hours after surgery
pain score at rest	The pain score at rest will be assessed using the Numeric Rating Scale (NRS), which ranges from 0 (representing "no pain") to 10 (representing "the worst pain").	96 hours after surgery
pain score during coughing	The pain score during coughing will be assessed using the Numeric Rating Scale (NRS), which ranges from 0 (representing "no pain") to 10 (representing "the worst pain").	96 hours after surgery
pain score at rest	The pain score at rest will be assessed using the Numeric Rating Scale (NRS), which ranges from 0 (representing "no pain") to 10 (representing "the worst pain").	120 hours after surgery
pain score during coughing	The pain score during coughing will be assessed using the Numeric Rating Scale (NRS), which ranges from 0 (representing "no pain") to 10 (representing "the worst pain").	120 hours after surgery
Consumption of analgesic drugs	the amount of analgesic drugs will be recorded	120 hours after surgery
Nerve block related adverse events	Any adverse event resulting from a nerve block, such as toxicity, allergic reactions, or nerve injuries, will be considered causally related.	120 hours after surgery
Block duration: first reported pain	Definition: timing begins at block performance	24 hours after surgery
Presence of pain 1 month after surgery assessed using the Brief Pain Inventory.	yes/no	1 month after surgery
Presence of pain 3 months after surgery assessed using the Brief Pain Inventory.	yes/no	3 months after surgery
Presence of pain 6 months after surgery assessed using the Brief Pain Inventory.	yes/no	6 months after surgery
Hospital Anxiety and Depression Scale, HADS	The Hospital Anxiety and Depression Scale (HADS) is primarily used to screen for anxiety and depression in general hospital patients. The HADS includes a total of 14 items, with 7 items assessing depression and 7 items assessing anxiety. There are six reverse question entries, five on the depression subscale and one on the anxiety subscale.	day1 before surgery
Insomnia Severity Index, ISI	The Insomnia Severity Index (ISI) is a self-assessment tool for self-perception of insomnia symptoms in the past two weeks. It includes 7 items, with each item scoring 0 to 4 points. The questions involve the subject's subjective evaluation of sleep quality, including the severity of symptoms and their satisfaction with their sleep patterns. The impact of insomnia on daily functioning, the subject's awareness of the impact of insomnia on themselves, and the level of depression caused by sleep disorders.	day1 before surgery
Charlson Comorbidity Index, CCI	The Charlson Comorbidity Index (CCI) is a commonly used evaluation method in clinical research to assess the health status of patients and predict their life expectancy by scoring coexisting diseases and age.	day1 before surgery
Complications within 120hours after surgery	Complications will be recorded.	Five days after surgery
The douleur neuropathique 4 questionnaire(DN4)	This questionnaire serves as a diagnostic tool for identifying neuropathic pain. It comprises 10 options, consisting of 7 self-assessment items that evaluate symptoms. The total score is 10 points, and a score of ≥ 4 indicates the possibility of neuropathic pain, while a score < 4 rules out neuropathic pain.	1 month after surgery
The douleur neuropathique 4 questionnaire(DN4)	This questionnaire serves as a diagnostic tool for identifying neuropathic pain. It comprises 10 options, consisting of 7 self-assessment items that evaluate symptoms. The total score is 10 points, and a score of ≥ 4 indicates the possibility of neuropathic pain, while a score < 4 rules out neuropathic pain.	3 months after surgery
The douleur neuropathique 4 questionnaire(DN4)	This questionnaire serves as a diagnostic tool for identifying neuropathic pain. It comprises 10 options, consisting of 7 self-assessment items that evaluate symptoms. The total score is 10 points, and a score of ≥ 4 indicates the possibility of neuropathic pain, while a score < 4 rules out neuropathic pain.	6 months after surgery

Collaborators and Investigators

• Sponsor: Feng Gao

Study record dates

Study Major Dates

• Study Start (Estimated): May 10, 2024
• Primary Completion (Estimated): December 21, 2025
• Study Completion (Estimated): December 21, 2025

Study Registration Dates

• First Submitted: May 5, 2024
• First Submitted That Met QC Criteria: May 5, 2024
• First Posted (Actual): May 8, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 5, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: liposomal bupivacaine; video-assisted thoracoscopic surgery; paravertebral nerve block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine; Ropivacaine
• Other Study ID Numbers: TJ-IRB202403005

Drug and device information, study documents

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