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Liposomal BupivacaineNCT07271979

Liposomal Bupivacaine Versus Ropivacaine for Preperitoneal Infiltration Analgesia in Upper Abdominal Laparotomy

A study testing Liposomal bupivacaine and ropivacaine in people with Liposomal Bupivacaine and Preperitoneal Infiltration, run by Qilu Hospital of Shandong University 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

Upper abdominal open surgery is associated with significant trauma, and postoperative pain management poses considerable challenges. The inflammatory response triggered by peritoneal incision and the transmission of visceral pain via the vagus nerve are key components of "surgical stress" and pain. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Liposomal bupivacaine and ropivacaine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
146 participants
Where
1 siteChina
Study dates
4 Jan 2026to 23 May 2026
Phase
Interventional
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18 to 75 years; for those >70 years old, a Karnofsky Performance Status (KPS) score ≥80 is required.
  • Scheduled for elective upper abdominal laparotomy.
  • Surgical approach involving either a subcostal or midline incision.
  • Incision length between 15 and 30 cm.
  • American Society of Anesthesiologists (ASA) physical status classification of I to III.

Who cannot join

  • ASA Physical Status Class greater than III.
  • Pre-existing chronic pain with long-term opioid use (for >1 year).
  • Significant hepatic or renal impairment, or underweight status, defined as:
  • Estimated glomerular filtration rate (eGFR) of <40 mL/min/1.73m²; Child-Pugh Class C; Body Mass Index (BMI) <18.5 kg/m².
  • Known allergy or hypersensitivity to the investigational drug or any of its excipients.
  • Pregnancy or lactation

Trial locations and contacts

1 site in 1 country.

China1 site
  • Qilu Hospital of Shandong University

    Jinan

Other trials in China

About this study

Official title: Liposomal Bupivacaine Versus Ropivacaine for Preperitoneal Infiltration Analgesia in Upper Abdominal Laparotomy: A Randomized Controlled Trial

Upper abdominal open surgery is associated with significant trauma, and postoperative pain management poses considerable challenges. The inflammatory response triggered by peritoneal incision and the transmission of visceral pain via the vagus nerve are key components of "surgical stress" and pain. A potential intervention strategy involves the local administration of anesthetic agents to suppress peritoneal overreaction and block the cascade of pro-inflammatory cytokines in related nerves. Liposomal bupivacaine, as a long-acting local anesthetic, may provide more prolonged postoperative analgesia compared to ropivacaine. Therefore, this trial aims to prospectively compare the analgesic efficacy and anti-inflammatory effects of the two drugs when administered as pre-closure preperitoneal infiltration. Secondary endpoints include opioid consumption, complication rates, and postoperative recovery indicators, to comprehensively evaluate their clinical value.

Read the detailed description

Patients undergoing upper gastrointestinal open surgery often experience moderate to severe postoperative pain, which not only hinders early recovery but also significantly impairs their quality of life. Ideal postoperative analgesia requires a balance between efficacy and safety, and preperitoneal local anesthetic administration serves as an effective strategy to achieve this goal. Compared to conventional local anesthetics, liposomal bupivacaine-as a novel sustained-release formulation-enables continuous drug release, extending the analgesic duration to 48-72 hours. This study aims to compare the postoperative analgesic effects of preperitoneal injection of liposomal bupivacaine versus ropivacaine in patients undergoing upper gastrointestinal open surgery.

This study employs a randomized controlled design. Participants will be stratified based on the type of surgical incision (midline or subcostal) and randomized into groups using a computer-generated random seed with permuted block randomization (variable block sizes of 2, 4). Prior to abdominal closure during surgery, the experimental group will receive liposomal bupivacaine injections into the preperitoneal space on both sides of the wound, while the control group will receive ropivacaine injections. Apart from this intervention, both groups will maintain identical protocols for anesthesia induction, maintenance, and postoperative systemic analgesia to accurately evaluate the relative efficacy of the two local analgesic agents.

Being tested
Liposomal bupivacaine, ropivacaine
Medical subject headings
Agnosia

What participants receive

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

  • Liposomal bupivacaineDrug

    Prior to abdominal closure, liposomal bupivacaine is administered preperitoneally along the surgical incision and diluted with normal saline according to the incision length.

  • ropivacaineDrug

    Prior to abdominal closure, ropivacaine is administered preperitoneally along the surgical incision and diluted with normal saline to a concentration of 0.3%.

Study groups in NCT07271979
Study groupRoleWhat they receive
Liposomal bupivacaineExperimentalPrior to abdominal closure, the subject received a preperitoneal administration of liposomal bupivacaine at the surgical incision site. The total injection dose did not exceed 266 mg. A volume of 1 ml of the drug solution was administered per 1.5 cm of wound length per side.
Receives: Drug: Liposomal bupivacaine
ropivacaineActive comparatorPrior to abdominal closure, the subject received a preperitoneal administration of 0.3% ropivacaine at the surgical incision site. A volume of 1 ml of the drug solution was administered per 1.5 cm of wound length per side.
Receives: Drug: ropivacaine

What is being measured

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

  1. postoperative pain score(NRS)

    The Numeric Rating Scale (NRS) is an 11-point scale ranging from 0 to 10, where 0 represents "no pain" and 10 represents the "worst pain imaginable." Based on this, scores of 1-3 indicate mild pain, 4-6 indicate moderate pain requiring intervention, and 7-10 indicate severe pain necessitating urgent treatment. In this study, the investigators primarily assessed the incidence of an NRS score ≥ 4 within 24 hours postoperatively and the worst pain experienced by patients during that period.

    Measured: Day 1

Secondary outcomes (11)
  1. Time to First Rescue Analgesia and Number of Effective Patient-Controlled Intravenous Analgesia (PCIA)

    The PCIA protocol (sufentanil 2 μg/kg in 100 mL saline, no background infusion, 3 mL bolus, 30-min lockout) was used. We recorded the time to first PCIA activation and the cumulative number of effective boluses within the first 72 postoperative hours.

    Measured: Day 3

  2. the use of flurbiprofen axetil

    the amount of rescue analgesic drugs flurbiprofen axetil used

    Measured: Day 3

  3. postoperative adverse events

    the incidence of nausea, vomiting, and vertigo after surgery

    Measured: The first 3 postoperative days

  4. The Richards-Campbell Sleep Questionnaire

    It uses a 0-100 mm visual analog scale, with higher scores indicating better sleep quality.

    Measured: day 3

  5. Quality of Recovery-15 (QOR-15) scale

    The scores from all 15 questions are summed to yield a total score ranging from 0 to 150, with a higher total score indicating a better quality of recovery for the patient.

    Measured: The first 3 postoperative days

  6. Overall Benefit of Analgesia Score

    This score is a patient-reported outcome measure for comprehensively evaluating the effectiveness of postoperative analgesic regimens, using a 29-point scale from 0 (best) to 28 (worst).

    Measured: The first three postoperative days

  7. Changes in postoperative pain

    Changes in pain scores (NRS) within the first 3 days postoperatively, including scores at rest at 6, 12, 24, 48, and 72 hours, as well as the peak pain level during this 3-day period.

    Measured: The first 3 postoperative days

  8. hospital length of stay

    The time between hospital admission and discharge

    Measured: From date of hospital admission until the date of discharge,assessed up to 15 days.

  9. C-reactive protein

    The inflammatory marker of participants will be test after surgery

    Measured: On the preoperative day and postoperative day 1

  10. White Blood Cell Count and Differential

    By analyzing the WBC profile-including both total count and cell type distribution-the inflammatory condition of a patient can be evaluated.

    Measured: Day 1

  11. Postoperative Complications

    The probability of patients acquiring pulmonary complications after surgery.

    Measured: One month 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 posted9 Dec 2025
  2. Study start4 Jan 2026
  3. Primary completion23 Apr 2026
  4. Study completion23 May 2026

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
146 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07271979
Sponsor's protocol ID
KYLL-202507-101-2
Status last verified
Jul 2026
First submitted
15 Nov 2025
Last updated
15 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Othman AH, Ahmed DG, Abd El-Rahman AM, El Sherif FA, Mansour S, Aboeleuon E. Effect of Preperitoneal Versus Epidural Analgesia on Postoperative Inflammatory Response and Pain Following Radical Cystectomy: A Prospective, Randomized Trial. Clin J Pain. 2019 Apr;35(4):328-334. doi: 10.1097/AJP.0000000000000679.

    PubMed 30829734
  • Colibaseanu DT, Osagiede O, Merchea A, Ball CT, Bojaxhi E, Panchamia JK, Jacob AK, Kelley SR, Naessens JM, Larson DW. Randomized clinical trial of liposomal bupivacaine transverse abdominis plane block versus intrathecal analgesia in colorectal surgery. Br J Surg. 2019 May;106(6):692-699. doi: 10.1002/bjs.11141. Epub 2019 Mar 28.

    PubMed 30919948
  • Pedrazzani C, Park SY, Conti C, Turri G, Park JS, Kim HJ, Polati E, Guglielmi A, Choi GS. Analgesic efficacy of pre-emptive local wound infiltration plus laparoscopic-assisted transversus abdominis plane block versus wound infiltration in patients undergoing laparoscopic colorectal resection: results from a randomized, multicenter, single-blind, non-inferiority trial. Surg Endosc. 2021 Jul;35(7):3329-3338. doi: 10.1007/s00464-020-07771-6. Epub 2020 Jul 6.

    PubMed 32632489
  • Gasanova I, Alexander J, Ogunnaike B, Hamid C, Rogers D, Minhajuddin A, Joshi GP. Transversus Abdominis Plane Block Versus Surgical Site Infiltration for Pain Management After Open Total Abdominal Hysterectomy. Anesth Analg. 2015 Nov;121(5):1383-8. doi: 10.1213/ANE.0000000000000909.

    PubMed 26252171
  • Beaussier M, El'Ayoubi H, Schiffer E, Rollin M, Parc Y, Mazoit JX, Azizi L, Gervaz P, Rohr S, Biermann C, Lienhart A, Eledjam JJ. Continuous preperitoneal infusion of ropivacaine provides effective analgesia and accelerates recovery after colorectal surgery: a randomized, double-blind, placebo-controlled study. Anesthesiology. 2007 Sep;107(3):461-8. doi: 10.1097/01.anes.0000278903.91986.19.

    PubMed 17721249
  • Tawfik MM, Mohamed YM, Elbadrawi RE, Abdelkhalek M, Mogahed MM, Ezz HM. Transversus Abdominis Plane Block Versus Wound Infiltration for Analgesia After Cesarean Delivery: A Randomized Controlled Trial. Anesth Analg. 2017 Apr;124(4):1291-1297. doi: 10.1213/ANE.0000000000001724.

    PubMed 27984230
  • Teo ZHT, Tey BLJ, Foo CW, Wong WY, Low JK. Intraoperative Celiac Plexus Block With Preperitoneal Infusion Reduces Opioid Usage in Major Hepato-pancreato-biliary Surgery: A Pilot Study. Ann Surg. 2021 Jul 1;274(1):e97-e99. doi: 10.1097/SLA.0000000000004883.

    PubMed 33856374
  • Ozer A, Yilmazlar A, Ozturk E, Yilmazlar T. Preperitoneal catheter analgesia is an effective method for pain management after colorectal surgery: the results of 100 consecutive patients. Local Reg Anesth. 2014 Oct 9;7:53-7. doi: 10.2147/LRA.S71476. eCollection 2014.

    PubMed 25336988
  • Alexander JC, Sunna M, Goldenmerry Y, Mootz A, O'Connor C, Ringqvist J, Bunker M, Joshi GP, Gasanova I. Comparison of transversus abdominis plane blocks with liposomal bupivacaine versus ropivacaine in open total abdominal hysterectomy. Proc (Bayl Univ Med Cent). 2022 Jun 30;35(6):746-750. doi: 10.1080/08998280.2022.2090798. eCollection 2022.

    PubMed 36304627
  • Ben-Saghroune H, Abdessadek M, Achour S, Kfal Y, El Bouazzaoui A, Kanjaa N, Sbai H. Assessment of the Safety and Efficiency of a Preperitoneal Continuous Infusion Using Bupivacaine after Abdominal Laparotomy in Digestive Carcinology. Anesthesiol Res Pract. 2023 Oct 10;2023:8842393. doi: 10.1155/2023/8842393. eCollection 2023.

    PubMed 37854305
  • Rawal N. Current issues in postoperative pain management. Eur J Anaesthesiol. 2016 Mar;33(3):160-71. doi: 10.1097/EJA.0000000000000366.

    PubMed 26509324
  • Sammour T, Kahokehr A, Soop M, Hill AG. Peritoneal damage: the inflammatory response and clinical implications of the neuro-immuno-humoral axis. World J Surg. 2010 Apr;34(4):704-20. doi: 10.1007/s00268-009-0382-y.

    PubMed 20049432
  • Baeriswyl M, Zeiter F, Piubellini D, Kirkham KR, Albrecht E. The analgesic efficacy of transverse abdominis plane block versus epidural analgesia: A systematic review with meta-analysis. Medicine (Baltimore). 2018 Jun;97(26):e11261. doi: 10.1097/MD.0000000000011261.

    PubMed 29952997
  • Ozturk E, Yilmazlar A, Coskun F, Isik O, Yilmazlar T. The beneficial effects of preperitoneal catheter analgesia following colon and rectal resections: a prospective, randomized, double-blind, placebo-controlled study. Tech Coloproctol. 2011 Sep;15(3):331-6. doi: 10.1007/s10151-011-0720-6. Epub 2011 Jul 19.

    PubMed 21769617
  • Joshi GP, Machi A. Surgical site infiltration: A neuroanatomical approach. Best Pract Res Clin Anaesthesiol. 2019 Sep;33(3):317-324. doi: 10.1016/j.bpa.2019.07.017. Epub 2019 Jul 25.

    PubMed 31785717

Questions about this trial

What is this clinical trial studying?

A study testing Liposomal bupivacaine and ropivacaine in people with Liposomal Bupivacaine and Preperitoneal Infiltration, run by Qilu Hospital of Shandong University 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 5 inclusion and 6 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 15 Jul 2026. 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.

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?

postoperative pain score(NRS) (time frame: Day 1). 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 NCT07271979, which also lists 18 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 15 Jul 2026.

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