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

NCT07271979 | Recruiting

• 1 other identifier: KYLL-202507-101-2
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Liposomal Bupivacaine; Preperitoneal Infiltration; Analgesia

Outcome Measures

Primary Outcomes (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.

  Day 1

Secondary Outcomes (11)

• Time to First Rescue Analgesia and Number of Effective Patient-Controlled Intravenous Analgesia (PCIA)

  Day 3

• the use of flurbiprofen axetil

  Day 3

• postoperative adverse events

  The first 3 postoperative days

• The Richards-Campbell Sleep Questionnaire

  day 3

• Quality of Recovery-15 (QOR-15) scale

  The first 3 postoperative days

Study Arms (2)

Liposomal bupivacaine

EXPERIMENTAL

Prior 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.

Drug: Liposomal bupivacaine

ropivacaine

ACTIVE COMPARATOR

Prior 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.

Drug: ropivacaine

Interventions

Liposomal bupivacaine DRUG

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

Liposomal bupivacaine

ropivacaine DRUG

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

ropivacaine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, China

RECRUITING

Related Publications (18)

• 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.

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• 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.

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• 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.

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• 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.

  PMID: 27984230 BACKGROUND

• 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.

  PMID: 33856374 BACKGROUND

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  PMID: 25336988 BACKGROUND

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  PMID: 36304627 BACKGROUND

• 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.

  PMID: 37854305 BACKGROUND

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

  PMID: 26509324 BACKGROUND

• 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.

  PMID: 20049432 BACKGROUND

• 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.

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• 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.

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• Mungroop TH, Bond MJ, Lirk P, Busch OR, Hollmann MW, Veelo DP, Besselink MG. Preperitoneal or Subcutaneous Wound Catheters as Alternative for Epidural Analgesia in Abdominal Surgery: A Systematic Review and Meta-analysis. Ann Surg. 2019 Feb;269(2):252-260. doi: 10.1097/SLA.0000000000002817.

  PMID: 29781846 BACKGROUND

• Perniola A, Fant F, Magnuson A, Axelsson K, Gupta A. Postoperative pain after abdominal hysterectomy: a randomized, double-blind, controlled trial comparing continuous infusion vs patient-controlled intraperitoneal injection of local anaesthetic. Br J Anaesth. 2014 Feb;112(2):328-36. doi: 10.1093/bja/aet345. Epub 2013 Oct 31.

  PMID: 24185607 BACKGROUND

• Mungroop TH, Veelo DP, Busch OR, van Dieren S, van Gulik TM, Karsten TM, de Castro SM, Godfried MB, Thiel B, Hollmann MW, Lirk P, Besselink MG. Continuous wound infiltration versus epidural analgesia after hepato-pancreato-biliary surgery (POP-UP): a randomised controlled, open-label, non-inferiority trial. Lancet Gastroenterol Hepatol. 2016 Oct;1(2):105-113. doi: 10.1016/S2468-1253(16)30012-7. Epub 2016 Jul 7.

  PMID: 28404067 BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Jinying Zhang

CONTACT

18560087707; zhjydzx@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: December 9, 2025
• Study Start: January 4, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

CN (1)