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

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06405724
• Other study ID #: TJ-IRB202403005
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 10, 2024
• Est. completion date: December 21, 2025

Study information

• Verified date: May 2024
• Source: Tongji Hospital
• Contact: Feng Gao, Doctor
• Phone: 13971587381
• Email: fgao[@]tjh.tjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 84
• Est. completion date: December 21, 2025
• Est. primary completion date: December 21, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Pain, Postoperative

Intervention

Drug:
• Liposomal bupivacaine
133mg LB 20mL thoracic paravertebral nerve block
• Ropivacaine
0.5% ropivacaine 20mL thoracic paravertebral nerve block

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Feng Gao

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Consumption of analgesic drugs	the amount of analgesic drugs will be recorded	120 hours after surgery
Secondary	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
Secondary	Block duration: first reported pain	Definition: timing begins at block performance	24 hours after surgery
Secondary	Presence of pain 1 month after surgery assessed using the Brief Pain Inventory.	yes/no	1 month after surgery
Secondary	Presence of pain 3 months after surgery assessed using the Brief Pain Inventory.	yes/no	3 months after surgery
Secondary	Presence of pain 6 months after surgery assessed using the Brief Pain Inventory.	yes/no	6 months after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Complications within 120hours after surgery	Complications will be recorded.	Five days after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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