Bupivacaine Liposome Serrate Anterior Plane Block vs Traditional Thoracic Paravertebral Block

NCT06135545 | Withdrawn

• 1 other identifier: 2023LY0519
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Lung Cancer

Keywords

Serratus anterior plane block; Thoracic paravertebral block; Liposomal bupivacaine; Video-assisted thoracoscopic surgery; Postoperative pain

Outcome Measures

Primary Outcomes (1)

• Postoperative NRS pain score at 24 hours

  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 Outcomes (4)

• Postoperative QoR-15

  24 to 72 hours after the surgery

• Cumulative opioid consumption after surgery

  72 hours after the surgery

• AUC of postoperative pain score

  72 hours after the surgery

• Postoperative NRS pain score

  1h, 6h, 48h, 72h after the surgery, separately.

Other Outcomes (2)

• The number of patients receiving rescue analgesia.

  24 to 72 hours after the surgery

• Number of patients with nausea and vomiting

  24 to 72 hours after the surgery

Study Arms (2)

T Group

EXPERIMENTAL

The T group used liposomal bupivacaine for ultrasound-guided serratus anterior plane block.

Combination Product: Bupivacaine Liposome SAPB

C Group

ACTIVE COMPARATOR

The C group used traditional ropivacaine for ultrasound-guided paravertebral nerve block.

Combination Product: Traditional TPVB

Interventions

Bupivacaine Liposome SAPB COMBINATION_PRODUCT

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.

Also known as: Bupivacaine Liposome Serrate Anterior Plane Block(SAPB)

T Group

Traditional TPVB COMBINATION_PRODUCT

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.

Also known as: Traditional Thoracic Paravertebral Block(TPVB)

C 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:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shiyou Wei: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200082, China

Location

Related Publications (9)

• Yeung 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 BACKGROUND

• Blanco 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 BACKGROUND

• Chong 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 BACKGROUND

• Sandeep 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 BACKGROUND

• Ilfeld 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 BACKGROUND

• Hu 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 BACKGROUND

• Rice 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.

  PMID: 28120158 BACKGROUND

• Krediet AC, Moayeri N, van Geffen GJ, Bruhn J, Renes S, Bigeleisen PE, Groen GJ. Different Approaches to Ultrasound-guided Thoracic Paravertebral Block: An Illustrated Review. Anesthesiology. 2015 Aug;123(2):459-74. doi: 10.1097/ALN.0000000000000747.

  PMID: 26083767 BACKGROUND

• Ding W, Chen Y, Li D, Wang L, Liu H, Wang H, Zeng X. Investigation of single-dose thoracic paravertebral analgesia for postoperative pain control after thoracoscopic lobectomy - A randomized controlled trial. Int J Surg. 2018 Sep;57:8-14. doi: 10.1016/j.ijsu.2018.07.006. Epub 2018 Jul 26.

  PMID: 30056127 RESULT

MeSH Terms

Conditions

Lung Neoplasms; Pain, Postoperative

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Jiong Song, MD.

  Shanghai Pulmonary Hospital, Shanghai, China

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Anesthesiology

Model Details: A randomized, double-blinded non-inferiority clinical trial.

Study Record Dates

• First Submitted: November 11, 2023
• First Posted: November 18, 2023
• Study Start: October 1, 2023
• Primary Completion: October 2, 2023
• Study Completion: October 3, 2023
• Last Updated: January 9, 2025

Record last verified: 2023-10

Locations

CN (1)