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Local AnestheticsPhase 4NCT06231355

Liposomal vs. Conventional Bupivacaine for Pain Control

A Phase 4 study testing Performing paravertebral nerve block with lipo-bupivacaine and Performing paravertebral nerve block with bupivacaine in people with Local Anesthetics and Analgesia, run by Peking University First Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Local Anesthetics, Analgesia, Regional Block
What is being tested?
Performing paravertebral nerve block with lipo-bupivacaine and Performing paravertebral nerve block with bupivacaine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
1 siteChina
Study dates
21 Feb 2024to 14 Oct 2024
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

Other trials in China

About this study

Official title: Efficacy of Liposomal Bupivacaine Versus Conventional Bupivacaine for Pain Control in Patients Undergoing Laparoscopic Radical Nephrectomy: A Pilot Randomized Trial

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.
Read the detailed description

Random numbers will be generated by an independent biostatistician in a 1:1 ratio, sealed in sequentially numbered opaque envelopes, and stored by a study coordinator. Only anesthesiologists who perform paravertebral block know group allocation but are not involved in other parts of the trial. Patients, other health-care team members, and investigators for data collection and outcome assessment are masked from group assignments.

Paravertebral block will be performed with either liposomal bupivacaine or plain bupivacaine. The efficacy of nerve block will be assessed every 5 minutes after local anesthetic injection. We will evaluate pain severity, opioid consumption, and occurrence of adverse events at the following timepoints, i.e., end of surgery, 30 minutes after surgery, and 2, 6, 12, 24, 36, 48, 60, and 72 hours after surgery. Additionally, occurrence of complications, quality of recovery, and subjective sleep quality will be assessed during hospital stay after surgery.

Being tested
Performing paravertebral nerve block with lipo-bupivacaine, Performing paravertebral nerve block with bupivacaine
Keywords
liposomal bupivacaine, paravertebral block, postoperative pain, nephrectomy
Medical subject headings
Agnosia, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Performing paravertebral nerve block with lipo-bupivacaineDrug

    Also called 艾恒平 (Ai Heng Ping), Bupivacaine liposome injection

    Paravertebral block is performed using liposomal bupivacaine.

  • Performing paravertebral nerve block with bupivacaineDrug

    Also called Bupivacaine injection

    Paravertebral block is performed using bupivacaine.

Study groups in NCT06231355
Study groupRoleWhat they receive
Lipo-bupivacaineExperimentalParavertebral block is performed with liposomal bupivacaine.
Receives: Drug: Performing paravertebral nerve block with lipo-bupivacaine
BupivacaineActive comparatorParavertebral block is performed with bupivacaine.
Receives: Drug: Performing paravertebral nerve block with bupivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Between 12 and 72 hours afer surgery

Secondary outcomes (7)
  1. Time to onset after paravertebral block

    Defined as time interval from end of nerve block to appearance of sensory block.

    Measured: From end of nerve block to initiation of surgery.

  2. Time to maximal block after paravertebral block

    Defined as time interval from end of nerve block to maximal block).

    Measured: From end of nerve block to initiation of surgery.

  3. Extent of paravertebral block

    Defined as maximal extent of block.

    Measured: From end of nerve block to 72 hours after surgery.

  4. Paravertebral block-related adverse events.

    Defined as any unpredictable, unfavourable medical event that is associated with paravertebral block.

    Measured: From end of nerve block to initiation of surgery.

  5. A composite index of pain intensity and opioid consumption (PIOC) within 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 0.5 and 72 hours in the postoperative period.

    Measured: Up to 72 hours after surgery

  6. Pain intensity within 72 hours after surgery

    The pain intensity will be assessed both at rest and with movement with the numeric rating scale (an 11-point scale where 0 = no pain, and 10 = the most severe pain) at 0.5, 2, 6, 12, 24, 36, 48, 60, and 72 hours after surgery.

    Measured: Up to 72 hours after surgery

  7. Cumulative opioid consumption within 72 hours after surgery.

    Cumulative opioid consumption within 72 hours after surgery.

    Measured: Up to 72 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2024
  2. Study start21 Feb 2024
  3. Primary completion9 Sep 2024
  4. Study completion14 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06231355
Sponsor's protocol ID
2023-553
Status last verified
Jul 2025
First submitted
21 Jan 2024
Last updated
30 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ergun M, Berkers AW, van der Jagt MF, Langenhuijsen JF, van Ozdemir-Brunschot D, van der Vliet JA, D'Ancona FC, Warle MC. Components of pain assessment after laparoscopic donor nephrectomy. Acta Anaesthesiol Scand. 2014 Feb;58(2):219-22. doi: 10.1111/aas.12236. Epub 2013 Dec 6.

    PubMed 24308727
  • Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022 Jan;72(1):7-33. doi: 10.3322/caac.21708. Epub 2022 Jan 12.

    PubMed 35020204
  • Mathuram Thiyagarajan U, Bagul A, Nicholson ML. Pain management in laparoscopic donor nephrectomy: a review. Pain Res Treat. 2012;2012:201852. doi: 10.1155/2012/201852. Epub 2012 Oct 23.

    PubMed 23150820
  • 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.

    PubMed 30833861
  • 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.

    PubMed 20448076
  • 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.

    PubMed 21676892
  • 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.

    PubMed 33464760
  • Chahar P, Cummings KC 3rd. Liposomal bupivacaine: a review of a new bupivacaine formulation. J Pain Res. 2012;5:257-64. doi: 10.2147/JPR.S27894. Epub 2012 Aug 14.

    PubMed 23049275
  • 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.

    PubMed 28781438
  • 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.

    PubMed 33376072
  • 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.

    PubMed 26633002
  • 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.

    PubMed 22570563
  • 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.

    PubMed 25912739
  • 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.

    PubMed 31550671
  • 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.

    PubMed 33372949

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Performing paravertebral nerve block with lipo-bupivacaine and Performing paravertebral nerve block with bupivacaine in people with Local Anesthetics and Analgesia, run by Peking University First Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

A composite index of pain intensity and opioid consumption (PIOC) between 12 and 72 hours after surgery (time frame: Between 12 and 72 hours afer surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06231355, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.

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