Bupivacaine Liposome Serrate Anterior Plane Block vs Traditional Thoracic Paravertebral Block

January 7, 2025 updated by: Shiyou Wei

Comparing the Postoperative Analgesic Effects of Bupivacaine Liposome Serrate Anterior Plane Block (SAPB) Versus Traditional Thoracic Paravertebral Block (TPVB): A Randomized, Double-blinded Non-inferiority Clinical Trial

In this study, patients will receive bupivacaine liposome serratus anterior plane block or ropivacaine paraspinal block to manage postoperative pain. Follow-up visits will be conducted to investigate the patient's postoperative pain and recovery quality. The investigators hypothesize that the simple and safe serratus anterior plane block with a novel long-acting local anesthetic (bupivacaine liposome) has analgesic efficacy and recovery quality that is not inferior to the currently commonly used bupivacaine paraspinal block.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Extensive research suggests that paravertebral block can replace thoracic epidural anesthesia as the "gold standard" for thoracic surgery pain relief. However, this technique is more challenging than the fascial plane block and carries the risk of damaging the pleura or spinal nerve roots. The serratus anterior plane block (SAPB) was refined by Blanco et al. in 2013 and is a new, safe regional anesthesia technique that can block the lateral cutaneous branches of the intercostal nerves from T2 to T9, as well as the long thoracic nerve, providing intraoperative and postoperative pain relief for surgeries in this area. A meta-analysis has reported that it can be an alternative regional anesthesia method to paravertebral and intercostal nerve blocks, and is technically safer, more effective, easier to perform, and may have fewer adverse reactions, making it more favored by clinicians. However, a recent network meta-analysis of regional block techniques in thoracic surgery suggested that, in terms of postoperative pain scores at 24 hours, SAPB can relieve pain but is slightly inferior to paravertebral block.

The duration of action of currently used local anesthetics is short. Although various adjuvants have been proposed, such as dexamethasone and dexmedetomidine, there are currently no drugs approved by the FDA that reliably extend the duration of local anesthetics beyond 24 hours (PMID: 27749354). Liposomal encapsulation of bupivacaine can extend the release time of local anesthetics to 72-96 hours (PMID: 23229686, 28120158), with the potential to reduce pain scores at 72 hours postoperatively (PMID: 22067185). Liposomal bupivacaine (Hengrui, Jiangsu) is also the first long-acting local anesthetic currently on the market in China, sparking new hope for anesthesiologists to better manage postoperative pain.

This study hypothesizes, from a clinical perspective, that the use of long-acting local anesthetic liposomal bupivacaine in a simplified and safe serratus anterior plane block technique for regional pain relief postoperatively is not inferior to the widely accepted gold standard for thoracic pain relief-paravertebral block with ropivacaine.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200082
        • Shanghai Pulmonary Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Elective unilateral thoracoscopic lung surgery.
  • Age between 18 and 75 years old.
  • American Society of Anesthesiologists (ASA) classification I to III.

Exclusion Criteria:

  • Contraindications to nerve block: puncture site infection, local anesthetic allergy, coagulation disorders or risk of bleeding.
  • Hepatic or renal dysfunction.
  • Pregnant, breastfeeding, possibility of pregnancy or planned pregnancy.
  • Use of analgesic drugs before surgery or history of chronic pain or opioid abuse.
  • Patients who refuse to participate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: T Group
The T group used liposomal bupivacaine for ultrasound-guided serratus anterior plane block.
Combination product: Bupivacaine Liposome SAPB
Dilute 266mg of bupivacaine liposome with saline solution to 30ml.The patients are placed in the lateral position and the probe is placed over the mid-clavicular region of the thoracic cage in a sagittal plane. The investigators count the ribs inferiorly and laterally, until The investigators identify the fifth rib in the midaxillary line. The latissimus dorsi (superficial and posterior), teres major (superior) and serratus muscles (deep and inferior) are then easily identifiable by ultrasound overlying the fifth rib.
Other Names:
  • Bupivacaine Liposome Serrate Anterior Plane Block(SAPB)
Active Comparator: C Group
The C group used traditional ropivacaine for ultrasound-guided paravertebral nerve block.
Combination product: Traditional TPVB
The TPVB was recommended by the American Society of Anesthesiologists.The transducer is placed sagitally over a transverse process(TP), placing it at the center of the ultrasound image. Alternatively, the space in-between two adjacent transverse processes may be positioned at the center. The needle is inserted using an out-of-plane technique and advanced until the central TP is contacted, or else the cranial of the two, with no or minimal angulation in the sagittal plane or the transversal plane. Subsequently, the needle is walked off the TP into the TPV space and advanced 1 to 1.5 cm beyond the TP without further visualizing the needle tip on ultrasound. Entering of the needle tip into the TPV space can result in a loss of resistance to normal saline and by visualizing anterior displacement of the pleura upon injection. Select the fifth TP as the insertion point, and inject 20ml of 0.5% ropivacaine (Hengrui, Jiangsu) into the TPV space.
Other Names:
  • Traditional Thoracic Paravertebral Block(TPVB)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative NRS pain score at 24 hours
Time Frame: 24 hours after the surgery
Postoperative numeric rating scales pain score at 24 hours after the surgery. Postoperative pain severity at rest and movement measured using a numerical rating scale(NRS) at 24 h. The numerical rating scale (NRS) is a line with numbers from 0 to 10 are spaced evenly across the page. And the NRS is bounded at the left-most end with "no pain" and at the right-most end with "worst pain imaginable". Pain levels below "4" are considered mild, "4-7" is moderate pain, and anything above "7" is considered severe pain. Patients are instructed to circle the number that represents the amount of pain that they are experiencing at the time of the evaluation. The movement status refers to maximum mobility of the upper arm of the surgical side. Remedial pain relief measures are initiated when the Numeric Rating Scale (NRS) score exceeds 4.
24 hours after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative QoR-15
Time Frame: 24 to 72 hours after the surgery
The 15-item quality of recovery(QoR-15) after the surgery. The QoR-15 scale is a global measurement of postoperative recovery, consisting of 15 items with 10 points each, with a total score ranging from 0 (QoR very poor) to 150 (QoR very good).
24 to 72 hours after the surgery
Cumulative opioid consumption after surgery
Time Frame: 72 hours after the surgery
Cumulative opioid consumption after surgery
72 hours after the surgery
AUC of postoperative pain score
Time Frame: 72 hours after the surgery
Area under the curve(AUC) of pain score 72 hours after surgery
72 hours after the surgery
Postoperative NRS pain score
Time Frame: 1h, 6h, 48h, 72h after the surgery, separately.
Pain scores at other time points except for the primary outcome. Postoperative pain severity at rest and movement measured using a numerical rating scale(NRS) at 24 h. The numerical rating scale (NRS) is a line with numbers from 0 to 10 are spaced evenly across the page. And the NRS is bounded at the left-most end with "no pain" and at the right-most end with "worst pain imaginable". Pain levels below "4" are considered mild, "4-7" is moderate pain, and anything above "7" is considered severe pain. Patients are instructed to circle the number that represents the amount of pain that they are experiencing at the time of the evaluation. The movement status refers to maximum mobility of the upper arm of the surgical side. Remedial pain relief measures are initiated when the Numeric Rating Scale (NRS) score exceeds 4.
1h, 6h, 48h, 72h after the surgery, separately.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of patients receiving rescue analgesia.
Time Frame: 24 to 72 hours after the surgery
The number of patients receiving rescue analgesia.
24 to 72 hours after the surgery
Number of patients with nausea and vomiting
Time Frame: 24 to 72 hours after the surgery
Number of patients who experienced nausea and vomiting after surgery.
24 to 72 hours after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shiyou Wei

Investigators

  • Study Director: Jiong Song, MD., Shanghai Pulmonary Hospital, Shanghai, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

October 2, 2023

Study Completion (Estimated)

October 3, 2023

Study Registration Dates

First Submitted

November 11, 2023

First Submitted That Met QC Criteria

November 11, 2023

First Posted (Actual)

November 18, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 7, 2025

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023LY0519

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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