Randomized Trial of Erector Spinae Plane Block Using Liposomal Bupivacaine Versus Bupivacaine Hydrochloride on Quality of Recovery for Video-assisted Thoracic Surgery

NCT07141667 | Not Yet Recruiting DMC

• 1 other identifier: LY2025-199-A
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

Video-assisted thoracoscopic surgery (VATS) has emerged as the standard surgical modality for pulmonary tumor. Compared with open thoracotomy, VATS is associated with reduced surgical trauma, attenuated postoperative pain, and a lower incidence of postoperative pulmonary complications. Nevertheless, 27-63% of VATS patients still develop moderate to severe postoperative pain, with the incidence of chronic postsurgical pain (CPSP) remaining at 25-44%. Regional analgesic techniques constitute a pivotal component of enhanced recovery after surgery (ERAS) protocols in thoracic surgery. Thoracic epidural analgesia (TEA) and paravertebral block (PVB) have been regarded as the gold-standard regional analgesic modalities for open thoracotomy. Accumulating evidence indicates that erector spinae plane block (ESPB) achieves postoperative analgesic efficacy comparable to that of PVB. In contrast to TEA, both PVB and ESPB are associated with a lower risk of complications such as hypotension, urinary retention, and epidural hematoma. A recent randomized controlled trial comparing continuous ESPB and continuous PVB demonstrated that continuous ESPB improves the quality of postoperative recovery in VATS patients. Previous studies have also confirmed that single-injection ESPB provides superior recovery quality and analgesic efficacy compared with single-injection PVB in VATS patients. However, single-dose nerve block only exert effects for 8-12 hours, while continuous nerve blocks may increase the risk of infection and compromise patient comfort. Moderate to severe postoperative pain in VATS patients predominantly occurs within the first 48 hours postoperatively, with the most intense pain typically observed on the first postoperative day. Therefore, there is an urgent need to explore analgesic techniques with prolonged duration and fewer complications for application in VATS. Liposomal bupivacaine, a novel extended-release local anesthetic approved by the FDA for clinical use, can prolong the duration of local anesthesia to 72 hours. Its clinical efficacy in procedures such as brachial plexus block has been validated. However, the application of liposomal bupivacaine in erector spinae plane block for VATS, and its impact on the quality of postoperative recovery, remains unreported.This study will test the hypothesis that erector spinae plane block with liposomal bupivacaine for VATS can enhance patients' quality of recovery-15 score (QoR-15) at 48 h.

Conditions

Regional Anesthesia Morbidity; Pain, Postoperative

Keywords

quality of recovery; erector spinae plane block; liposomal bupivacaine; video-assisted thoracic surgery

Outcome Measures

Primary Outcomes (1)

• Quality of recovery-15 score (QoR-15) at 48 h

  QoR-15 is a 15-parameter questionnaire which has been recommended as an optimum tool to evaluate overall patient recovery after surgery and this includes postoperative pain. Participants will complete this questionnaire at 48 hours after their surgery. It is scored between 0 and 150, where 150 indicates that the patient has had an excellent recovery.

  48 hours postoperative

Secondary Outcomes (7)

• Quality of recovery-15 score (QoR-15) at 24 h

  24 hours postoperative

• Numerical Rating Scale (NRS) for pain at rest when leaving the PACU, as well as at 4 hours, 24 hours, and 48 hours postoperatively

  Upon discharge from the recovery room(PACU),4 hours,24 hours and 48 hours postoperative

• Numerical Rating Scale (NRS) for pain during coughing when leaving the PACU, as well as at 4 hours, 24 hours, and 48 hours postoperatively

  Upon discharge from the recovery room(PACU),4 hours,24 hours and 48 hours postoperative

• Area under the curve (AUC) of NRS for pain at rest and during coughing within 48 hours

  48 hours postoperative

• Cumulative consumption of opioids within 48 hours postoperatively

  48 hours postoperative

Study Arms (2)

Bupivacaine HCL Group

ACTIVE COMPARATOR

Erector spinae plane block with normal saline 10ml and bupivacaine HCL 0.5% 20ml

Procedure: Erector spinae plane block with bupivacaine HCL

Liposomal Bupivacaine Group

EXPERIMENTAL

Erector spinae plane block with normal saline 10ml and liposomal bupivacaine 1.33% 20ml

Procedure: Erector spinae plane block with liposomal bupivacaine

Interventions

Erector spinae plane block with liposomal bupivacaine PROCEDURE

In the anesthesia induction suite, the anesthesiologist administers an ultrasound-guided erector spinae plane (ESP) block under local anesthesia prior to the induction of general anesthesia. The procedure involves the sequential injection of 10 mL of normal saline, followed by the administration of 20 mL of 1.33% liposomal bupivacaine.

Liposomal Bupivacaine Group

Erector spinae plane block with bupivacaine HCL PROCEDURE

In the anesthesia induction suite, the anesthesiologist administers an ultrasound-guided erector spinae plane (ESP) block under local anesthesia prior to the induction of general anesthesia. The procedure involves the sequential injection of 10 mL of normal saline, followed by the administration of 20 mL of 0.5% bupivacaine HCL.

Bupivacaine HCL Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• yr of age
• ASA physical status 1 to 3
• Undergoing unilateral lung VATS under general anesthesia
• Obtaining informed consent from patients or legal representative

You may not qualify if:

• Unexpected convention of VATS to open thoracotomy,or unexpected post-operative admission to ICU for continued ventilation
• Unable to understand the Quality of Recovery-15 (QoR-15) and Numerical Rating Scale(NRS)
• Allergy to or contraindications for amide local anesthetics,opioids,or NSAIDs
• Long-term treatment with opioids or corticosteroids (\>2 weeks)
• Drug use or substance abuse within the past 2 years
• Consuming more than 3 standard drinks per day (10g of alcohol,equivalent to 50g of Chinese high-alcohol liquor)
• Pre existing dementia that may interfere with perioperative assessment
• Contraindications for nerve block,including infection or tumor at the puncture site,definitively diagnosed diabetic peripheral neuropathy
• Suffering from severe hepatic insufficiency (Child-Pugh C),or severe renal insufficiency with dialysis,or severe heart failure (METS\<4)
• Pregnant or lactating women
• Previous thoracic surgeries (such an thoracic surgery or breast surgery),or preoperatively pathological pain conditions (e.g.,metastatic tumors,herpes zoster,etc)

Sponsors & Collaborators

• RenJi Hospital: lead

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

zhisheng Lu

CONTACT

+8618916951095; luzhisheng@renji.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This study adopts a single-blind design, where participants will be kept blinded to their assigned groups to minimize bias in subjective evaluations. Anesthesia providers will be responsible for screening and enrolling eligible patients, as well as administering the assigned anesthesia protocols. Importantly, the roles of anesthesia providers and postoperative follow-up personnel will be strictly separated, with the latter remaining unaware of the randomization details throughout the entire study period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single-blind, prospective, randomized controlled trial. Eligible patients scheduled for elective unilateral thoracic pulmonary resection will be randomly allocated to either the liposomal bupivacaine group or the bupivacaine HCL group. Patients in the liposomal bupivacaine group will undergo ultrasound-guided erector spinae plane block with liposomal bupivacaine, whereas those in the bupivacaine HCL group will receive ultrasound-guided erector spinae plane nerve block with bupivacaine hydrochloride.

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: August 26, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: August 26, 2025

Record last verified: 2025-08