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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRenJi Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18-75 yr of age

ASA physical status 1 to 3

Undergoing unilateral lung VATS under general anesthesia

Obtaining informed consent from patients or legal representative

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Erector spinae plane block with liposomal bupivacaine

    Procedure/Surgery

    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.

  • Erector spinae plane block with bupivacaine HCL

    Procedure/Surgery

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Bupivacaine HCL GroupActive comparator 1 intervention
Group B: Liposomal Bupivacaine GroupExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
48 hours postoperative

Secondary outcomes

1

Quality of recovery-15 score (QoR-15) at 24 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.

Time frame
24 hours postoperative
2

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

Numerical Rating Scale pain score is measured from 0 to 10 where 0 is no pain and 10 is severe pain.

Time frame
Upon discharge from the recovery room(PACU),4 hours,24 hours and 48 hours postoperative
3

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

Numerical Rating Scale pain score is measured from 0 to 10 where 0 is no pain and 10 is severe pain.

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

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

Numerical Rating Scale pain score is measured from 0 to 10 where 0 is no pain and 10 is severe pain.

Time frame
48 hours postoperative

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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