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Effect of Liposomal Bupivacaine TAPB Combined With Oxycodone PCIA on Postoperative Gastrointestinal Recovery in Patients Undergoing Major Abdominal Surgery

10. juni 2026 opdateret af: Wenli Yu, Tianjin First Central Hospital

Effect of Liposomal Bupivacaine TAPB Combined With Oxycodone PCIA on Postoperative Gastrointestinal Function in Patients Undergoing Major Abdominal Surgery: A Randomized Controlled Trial

Rationale and Objective:

The purpose of this study is to evaluate the clinical efficacy and safety of a novel multimodal analgesia regimen, combining transversus abdominis plane block (TAPB) with patient-controlled intravenous analgesia (PCIA), in improving postoperative gastrointestinal function recovery in patients undergoing major abdominal surgery.

Study Design and Interventions:

This is a prospective, single-center, randomized, double-blind, parallel-controlled trial. A total of 132 eligible patients (aged 18-80 years, ASA I-III, scheduled for elective small bowel or colorectal surgery) will be randomly allocated to one of three groups (n = 44 per group) to receive distinct postoperative analgesia regimens:

Group R-S: 0.375% Ropivacaine TAPB + Sufentanil PCIA; Group LB-S: 266 mg Liposomal Bupivacaine TAPB + Sufentanil PCIA; Group LB-O: 266 mg Liposomal Bupivacaine TAPB + Oxycodone PCIA.

Primary Outcome:

The primary outcome is the area under the curve (AUC) of the I-FEED scoring system within the first 7 postoperative days, which comprehensively reflects the overall trajectory of gastrointestinal function recovery.

Hypothesis:

The investigators hypothesize that the combination of long-acting Liposomal Bupivacaine TAPB (for prolonged somatic pain relief) and Oxycodone PCIA (for precise visceral pain control via dual u and k receptor agonism) will synergistically attenuate the perioperative stress-inflammatory response. Consequently, this regimen is expected to significantly mitigate postoperative ileus (POI) and accelerate the recovery of gastrointestinal motility

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

132

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Yu

Undersøgelse Kontakt Backup

Studiesteder

  • Kina
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Kina, 300384
        • Tianjin First Central Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Patients scheduled to undergo elective major abdominal surgery, specifically small bowel or colorectal resections.
  • Aged between 18 and 80 years (inclusive).
  • American Society of Anesthesiologists (ASA) physical status I, II, or III.
  • Capable of understanding the study procedures, cooperating with postoperative pain/recovery assessments (e.g., VAS, QoR-15, I-FEED), and providing written informed consent prior to surgery.

Exclusion Criteria:

  • History of significant neuropsychiatric disorders, including schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis, that may interfere with pain perception or cognitive evaluation.
  • History of alcohol abuse or chronic opioid/analgesic dependence.
  • Severe, uncontrolled hypertension (defined as systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg).
  • Severe cardiac, hepatic, renal, or pulmonary dysfunction that poses a high surgical/anesthetic risk or alters drug metabolism.
  • Pregnant or lactating women.
  • Known allergy, hypersensitivity, or contraindications to any of the study medications, including local anesthetics (ropivacaine, bupivacaine) or opioids (sufentanil, oxycodone).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Control Group（Ropivacaine + Sufentanil）
TAP block with 0.375% Ropivacaine + PCIA Sufentanil for postoperative analgesia after abdominal surgery
Medicin: ropivacaine hydrochloride
0.375% solution for transversus abdominis plane (TAP) local injection during surgery for postoperative analgesia.
Medicin: Sufentanil citrate
Formulated into PCIA pump for continuous intravenous infusion for postoperative patient-controlled analgesia.
Eksperimentel: Experimental Group 1（Liposomal Bupivacaine + Sufentanil）
TAP block with Liposomal Bupivacaine 266mg + PCIA Sufentanil for postoperative analgesia after abdominal surgery
Medicin: Sufentanil citrate
Formulated into PCIA pump for continuous intravenous infusion for postoperative patient-controlled analgesia.
Medicin: Liposomal bupivacaine (LB)
266mg single dose for TAP block local injection for postoperative pain control after abdominal surgery.
Eksperimentel: Experimental Group 2（Liposomal Bupivacaine + Oxycodone）
TAP block with Liposomal Bupivacaine 266mg + PCIA Oxycodone for postoperative analgesia after abdominal surgery
Medicin: Liposomal bupivacaine (LB)
266mg single dose for TAP block local injection for postoperative pain control after abdominal surgery.
Medicin: oxycodone
Prepared in PCIA pump for intravenous patient-controlled analgesia after abdominal operation.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Area Under Curve (AUC) of I-FEED Score within Postoperative 7 Days
Tidsramme: Postoperative Day 1 to Postoperative Day 7
The I-FEED score was recorded daily on days 1 through 7; the area under the curve (AUC) of the consecutive I-FEED scores within 7 days postoperatively was calculated to comprehensively assess the recovery of postoperative gastrointestinal function. A higher score indicates poorer recovery of gastrointestinal function. An I-FEED score > 6 indicates severe gastrointestinal dysfunction.
Postoperative Day 1 to Postoperative Day 7

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time-Weighted Average (TWA) of Rest & Movement NRS Pain Score within 72h Postoperatively
Tidsramme: Resting pain and activity-induced pain were assessed using a numerical rating scale (NRS, 0-10; higher scores indicate more severe pain) at predetermined time points, and the time-weighted average score was calculated for the 72-hour postoperative period
Postoperative 6h,12h,24h,48h,72h
Resting pain and activity-induced pain were assessed using a numerical rating scale (NRS, 0-10; higher scores indicate more severe pain) at predetermined time points, and the time-weighted average score was calculated for the 72-hour postoperative period
TWA of Short-form McGill Pain Questionnaire 2 (SF-MPQ-2) Score within Postoperative 72h
Tidsramme: Postoperative 24h,48h,72h
The Short-form McGill Pain Questionnaire 2 (SF-MPQ-2) Score (consisting of 22 items, each scored on a scale of 0-10, with higher scores indicating more severe pain) was used to distinguish between somatic pain and visceral pain; the weighted average (TWA) of the visceral pain subscale scores was calculated.
Postoperative 24h,48h,72h
Total opioid dose (morphine equivalent) within 72 hours postoperatively
Tidsramme: 0-72 hours after surgery
The cumulative doses of sufentanil or oxycodone administered via the PCIA pump within 72 hours postoperatively, as well as the doses of opioid rescue analgesics, were converted to morphine equivalents to facilitate intergroup comparisons.
0-72 hours after surgery
Incidence of Prolonged Postoperative Ileus (PPOI)
Tidsramme: Within postoperative 7 days
PPOI defined as patients without mechanical bowel obstruction who meet ≥2 of 5 criteria after postoperative 72h: persistent PONV, intolerance to solid diet, no flatus/stool, obvious abdominal distension, daily I-FEED>6 points。
Within postoperative 7 days
First Flatus & First Defecation Time
Tidsramme: The time from the end of surgery to the first flatus and the first defecation was recorded. The maximum follow-up duration was 7 days postoperatively.
Record interval from operation completion to the first spontaneous flatus and first spontaneous defecation separately, marker of gastrointestinal peristalsis recovery.
The time from the end of surgery to the first flatus and the first defecation was recorded. The maximum follow-up duration was 7 days postoperatively.
First Ambulation Time & Length of Hospital Stay(LOS)
Tidsramme: Time from the end of surgery to first ambulation and time to hospital discharge after surgery were recorded, with follow-up capped at 2 weeks postoperatively.
Record time of first independent ambulation after surgery and total postoperative hospital days.
Time from the end of surgery to first ambulation and time to hospital discharge after surgery were recorded, with follow-up capped at 2 weeks postoperatively.
QoR-15 Recovery Score
Tidsramme: Postoperative day 1，Postoperative day 2 ，Postoperative day 3
The QoR-15 questionnaire was administered on days 1, 2, and 3 postoperatively to assess overall postoperative recovery quality, with preoperative baseline scores used as covariates in the statistical analysis. The questionnaire consists of 15 items, each scored on a scale of 0 to 10, for a total score of 150. A higher score indicates better recovery quality.
Postoperative day 1，Postoperative day 2 ，Postoperative day 3
Incidence of Postoperative Adverse Events
Tidsramme: Postoperative Day 1 - Day7
Calculate the incidence of postoperative nausea and vomiting (PONV), constipation, dizziness, and respiratory depression (SpO₂ < 95% or respiratory rate < 10 breaths per minute) within 7 days postoperatively.
Postoperative Day 1 - Day7

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Serum IL-6 and Cortisol Concentrations
Tidsramme: End of surgery, Postoperative Day1, Postoperative Day2
Serum levels of interleukin-6 and cortisol were measured at three time points to assess perioperative inflammatory and surgical stress response.
End of surgery, Postoperative Day1, Postoperative Day2
Serum Motilin and Gastrin Concentrations
Tidsramme: End of surgery, Postoperative Day1, Postoperative Day2
Detect serum motilin and gastrin to explore the effect of analgesic regimens on gastrointestinal endocrine function.
End of surgery, Postoperative Day1, Postoperative Day2
Plasma β-Endorphin Concentration
Tidsramme: End of surgery, Postoperative Day1, Postoperative Day2
Determine plasma β-endorphin level to explore central pain modulation mechanism of multimodal analgesia.
End of surgery, Postoperative Day1, Postoperative Day2

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Tianjin First Central Hospital

Efterforskere

  • Studieleder: Wenli Yu, Tianjin First Central Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. september 2026

Studieafslutning (Anslået)

1. september 2026

Datoer for studieregistrering

Først indsendt

5. juni 2026

Først indsendt, der opfyldte QC-kriterier

10. juni 2026

Først opslået (Faktiske)

16. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TJH-2026-99

Plan for individuelle deltagerdata (IPD)

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IPD-planbeskrivelse

Individual participant data (IPD) will be made available upon reasonable request to the corresponding author, beginning 12 months after the publication of the primary results manuscript.

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