Liposomal vs. Conventional Bupivacaine for Pain Control

NCT06231355 | Completed Phase 4

• 1 other identifier: 2023-553
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this pilot study is to test the hypothesis that liposomal bupivacaine extends the duration of paravertebral block in patients undergoing radical nephrectomy, achieving improved analgesia compared to conventional bupivacaine. The main questions it aims to answer are:

• Area under curve of numeric rating scale of pain from 12 to 72 h after surgery.
• Cumulative opioid consumption during the period of 12 to 72 h after surgery.

Conditions

Local Anesthetics; Analgesia; Regional Block; Paravertebral Block

Keywords

liposomal bupivacaine; paravertebral block; postoperative pain; nephrectomy

Outcome Measures

Primary Outcomes (1)

• A composite index of pain intensity and opioid consumption (PIOC) between 12 and 72 hours after surgery

  The composite index of pain intensity and opioid consumption (PIOC) will be calculated using the area under curve (AUC) of pain intensity and cumulative opioid consumption between 12 and 72 hours in the postoperative period.

  Between 12 and 72 hours afer surgery

Secondary Outcomes (7)

• Time to onset after paravertebral block

  From end of nerve block to initiation of surgery.

• Time to maximal block after paravertebral block

  From end of nerve block to initiation of surgery.

• Extent of paravertebral block

  From end of nerve block to 72 hours after surgery.

• Paravertebral block-related adverse events.

  From end of nerve block to initiation of surgery.

• A composite index of pain intensity and opioid consumption (PIOC) within 72 hours after surgery.

  Up to 72 hours after surgery

Other Outcomes (8)

• Patients' satisfaction with pain management.

  Up to 3 days after surgery.

• Incidence of postoperative complications

  Up to 30 days after surgery

• Quality of recovery

  At 24 hours after surgery and discharge

Study Arms (2)

Lipo-bupivacaine

EXPERIMENTAL

Paravertebral block is performed with liposomal bupivacaine.

Drug: Performing paravertebral nerve block with lipo-bupivacaine

Bupivacaine

ACTIVE COMPARATOR

Paravertebral block is performed with bupivacaine.

Drug: Performing paravertebral nerve block with bupivacaine

Interventions

Performing paravertebral nerve block with lipo-bupivacaine DRUG

Paravertebral block is performed using liposomal bupivacaine.

Also known as: 艾恒平 (Ai Heng Ping), Bupivacaine liposome injection

Lipo-bupivacaine

Performing paravertebral nerve block with bupivacaine DRUG

Paravertebral block is performed using bupivacaine.

Also known as: Bupivacaine injection

Bupivacaine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 70 years old.
• Scheduled for laparoscopic-assisted unilateral radical nephrectomy.
• Agree to undergo regional nerve blockade and receive patient-controlled intravenous analgesia after surgery.

You may not qualify if:

• Renal cancer with venous thrombus of grade II or higher, or cases that may convert to open surgery.
• Body mass index ≥30 kg/m² or ≤15 kg/m².
• Severe renal dysfunction (serum creatinine \>442 μmol/L or requiring renal replacement therapy), severe liver dysfunction (Child-Pugh class C), or American Society of Anesthesiologists class ≥IV.
• Contraindications for deep nerve block, including severe spinal deformity or history of spinal surgery, severe coagulation abnormalities (international normalized ratio \>1.7, activated partial thromboplastin time \>4 seconds above normal, platelet count \<80×10⁹/L), trauma or infection at the planned puncture site, or severe lumbar back pain.
• Chronic opioid dependence and long-term use of various analgesics for more than 3 months.
• Preoperative inability to communicate due to severe dementia, language barriers, or end-stage diseases.
• Preoperative concomitant central nervous system and/or peripheral nervous system diseases.
• Planned endotracheal intubation and admission to the intensive care unit after surgery.
• Known allergy to local anesthetics.
• Other conditions that are deemed unsuitable for trial participation by the attending surgeons or investigators.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Related Publications (20)

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• Simpson JC, Bao X, Agarwala A. Pain Management in Enhanced Recovery after Surgery (ERAS) Protocols. Clin Colon Rectal Surg. 2019 Mar;32(2):121-128. doi: 10.1055/s-0038-1676477. Epub 2019 Feb 28.

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• Thavaneswaran P, Rudkin GE, Cooter RD, Moyes DG, Perera CL, Maddern GJ. Brief reports: paravertebral block for anesthesia: a systematic review. Anesth Analg. 2010 Jun 1;110(6):1740-4. doi: 10.1213/ANE.0b013e3181da82c8. Epub 2010 May 6.

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• Cummings KC 3rd, Napierkowski DE, Parra-Sanchez I, Kurz A, Dalton JE, Brems JJ, Sessler DI. Effect of dexamethasone on the duration of interscalene nerve blocks with ropivacaine or bupivacaine. Br J Anaesth. 2011 Sep;107(3):446-53. doi: 10.1093/bja/aer159. Epub 2011 Jun 14.

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• Safa B, Flynn B, McHardy PG, Kiss A, Haslam L, Henry PD, Kaustov L, Choi S. Comparison of the Analgesic Duration of 0.5% Bupivacaine With 1:200,000 Epinephrine Versus 0.5% Ropivacaine Versus 1% Ropivacaine for Low-Volume Ultrasound-Guided Interscalene Brachial Plexus Block: A Randomized Controlled Trial. Anesth Analg. 2021 Apr 1;132(4):1129-1137. doi: 10.1213/ANE.0000000000005373.

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• Malik O, Kaye AD, Kaye A, Belani K, Urman RD. Emerging roles of liposomal bupivacaine in anesthesia practice. J Anaesthesiol Clin Pharmacol. 2017 Apr-Jun;33(2):151-156. doi: 10.4103/joacp.JOACP_375_15.

  PMID: 28781438 BACKGROUND

• Pedoto A, Noel J, Park BJ, Amar D. Liposomal Bupivacaine Versus Bupivacaine Hydrochloride for Intercostal Nerve Blockade in Minimally Invasive Thoracic Surgery. J Cardiothorac Vasc Anesth. 2021 May;35(5):1393-1398. doi: 10.1053/j.jvca.2020.11.067. Epub 2020 Dec 2.

  PMID: 33376072 BACKGROUND

• Balkhy HH, Arnsdorf S, Krienbring D, Urban J. Liposome Bupivacaine for Postsurgical Analgesia in Patients Undergoing Robotically Assisted Cardiac Surgery. Innovations (Phila). 2015 Nov-Dec;10(6):416-9. doi: 10.1097/IMI.0000000000000190.

  PMID: 26633002 BACKGROUND

• Bergese SD, Ramamoorthy S, Patou G, Bramlett K, Gorfine SR, Candiotti KA. Efficacy profile of liposome bupivacaine, a novel formulation of bupivacaine for postsurgical analgesia. J Pain Res. 2012;5:107-16. doi: 10.2147/JPR.S30861. Epub 2012 May 1.

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• Rice DC, Cata JP, Mena GE, Rodriguez-Restrepo A, Correa AM, Mehran RJ. Posterior Intercostal Nerve Block With Liposomal Bupivacaine: An Alternative to Thoracic Epidural Analgesia. Ann Thorac Surg. 2015 Jun;99(6):1953-60. doi: 10.1016/j.athoracsur.2015.02.074. Epub 2015 Apr 23.

  PMID: 25912739 BACKGROUND

• NeMoyer RE, Pantin E, Aisner J, Jongco R, Mellender S, Chiricolo A, Moore DF, Langenfeld J. Paravertebral Nerve Block With Liposomal Bupivacaine for Pain Control Following Video-Assisted Thoracoscopic Surgery and Thoracotomy. J Surg Res. 2020 Feb;246:19-25. doi: 10.1016/j.jss.2019.07.093. Epub 2019 Sep 21.

  PMID: 31550671 BACKGROUND

• Ilfeld BM, Eisenach JC, Gabriel RA. Clinical Effectiveness of Liposomal Bupivacaine Administered by Infiltration or Peripheral Nerve Block to Treat Postoperative Pain. Anesthesiology. 2021 Feb 1;134(2):283-344. doi: 10.1097/ALN.0000000000003630.

  PMID: 33372949 BACKGROUND

• Hussain N, Brull R, Sheehy B, Essandoh MK, Stahl DL, Weaver TE, Abdallah FW. Perineural Liposomal Bupivacaine Is Not Superior to Nonliposomal Bupivacaine for Peripheral Nerve Block Analgesia. Anesthesiology. 2021 Feb 1;134(2):147-164. doi: 10.1097/ALN.0000000000003651.

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• Dinges HC, Wiesmann T, Otremba B, Wulf H, Eberhart LH, Schubert AK. The analgesic efficacy of liposomal bupivacaine compared with bupivacaine hydrochloride for the prevention of postoperative pain: a systematic review and meta-analysis with trial sequential analysis. Reg Anesth Pain Med. 2021 Jun;46(6):490-498. doi: 10.1136/rapm-2020-102427. Epub 2021 Apr 9.

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• Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.

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• Myles PS, Hunt JO, Nightingale CE, Fletcher H, Beh T, Tanil D, Nagy A, Rubinstein A, Ponsford JL. Development and psychometric testing of a quality of recovery score after general anesthesia and surgery in adults. Anesth Analg. 1999 Jan;88(1):83-90. doi: 10.1097/00000539-199901000-00016.

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MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Dong-Xin Wang, MD, PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 21, 2024
• First Posted: January 30, 2024
• Study Start: February 21, 2024
• Primary Completion: September 9, 2024
• Study Completion: October 14, 2024
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)