Clinical trial · Interventional
Bupivacaine Liposome Serrate Anterior Plane Block vs Traditional Thoracic Paravertebral Block
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of funding
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bupivacaine Liposome SAPB | Combination Product | — | UNRESOLVED |
| Traditional TPVB | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- T Group
- description
- The T group used liposomal bupivacaine for ultrasound-guided serratus anterior plane block.
- interventionNames
- Combination Product: Bupivacaine Liposome SAPB
- type
- ACTIVE_COMPARATOR
- label
- C Group
- description
- The C group used traditional ropivacaine for ultrasound-guided paravertebral nerve block.
- interventionNames
- Combination Product: Traditional TPVB
Primary outcomes (1)
- measure
- Postoperative NRS pain score at 24 hours
- timeFrame
- 24 hours after the surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (9)
- BACKGROUNDYeung JH, Gates S, Naidu BV, Wilson MJ, Gao Smith F. Paravertebral block versus thoracic epidural for patients undergoing thoracotomy. Cochrane Database Syst Rev. 2016 Feb 21;2(2):CD009121. doi: 10.1002/14651858.CD009121.pub2. PMID 26897642
- BACKGROUNDBlanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7. PMID 23923989
- BACKGROUNDChong M, Berbenetz N, Kumar K, Lin C. The serratus plane block for postoperative analgesia in breast and thoracic surgery: a systematic review and meta-analysis. Reg Anesth Pain Med. 2019 Oct 23:rapm-2019-100982. doi: 10.1136/rapm-2019-100982. Online ahead of print. PMID 31649029
- BACKGROUNDSandeep B, Huang X, Li Y, Xiong D, Zhu B, Xiao Z. A comparison of regional anesthesia techniques in patients undergoing video-assisted thoracic surgery: A network meta-analysis. Int J Surg. 2022 Sep;105:106840. doi: 10.1016/j.ijsu.2022.106840. Epub 2022 Aug 24. PMID 36030040
- BACKGROUNDIlfeld BM. Continuous Peripheral Nerve Blocks: An Update of the Published Evidence and Comparison With Novel, Alternative Analgesic Modalities. Anesth Analg. 2017 Jan;124(1):308-335. doi: 10.1213/ANE.0000000000001581. PMID 27749354
- BACKGROUNDHu D, Onel E, Singla N, Kramer WG, Hadzic A. Pharmacokinetic profile of liposome bupivacaine injection following a single administration at the surgical site. Clin Drug Investig. 2013 Feb;33(2):109-15. doi: 10.1007/s40261-012-0043-z. PMID 23229686
- BACKGROUNDRice D, Heil JW, Biernat L. Pharmacokinetic Profile and Tolerability of Liposomal Bupivacaine Following a Repeated Dose via Local Subcutaneous Infiltration in Healthy Volunteers. Clin Drug Investig. 2017 Mar;37(3):249-257. doi: 10.1007/s40261-017-0495-2.