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

10 giugno 2026 aggiornato da: 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

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

132

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Yu

Backup dei contatti dello studio

Luoghi di studio

  • Cina
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Cina, 300384
        • Tianjin First Central Hospital
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Control Group（Ropivacaine + Sufentanil）
TAP block with 0.375% Ropivacaine + PCIA Sufentanil for postoperative analgesia after abdominal surgery
Droga: ropivacaine hydrochloride
0.375% solution for transversus abdominis plane (TAP) local injection during surgery for postoperative analgesia.
Droga: Sufentanil citrate
Formulated into PCIA pump for continuous intravenous infusion for postoperative patient-controlled analgesia.
Sperimentale: Experimental Group 1（Liposomal Bupivacaine + Sufentanil）
TAP block with Liposomal Bupivacaine 266mg + PCIA Sufentanil for postoperative analgesia after abdominal surgery
Droga: Sufentanil citrate
Formulated into PCIA pump for continuous intravenous infusion for postoperative patient-controlled analgesia.
Droga: Liposomal bupivacaine (LB)
266mg single dose for TAP block local injection for postoperative pain control after abdominal surgery.
Sperimentale: Experimental Group 2（Liposomal Bupivacaine + Oxycodone）
TAP block with Liposomal Bupivacaine 266mg + PCIA Oxycodone for postoperative analgesia after abdominal surgery
Droga: Liposomal bupivacaine (LB)
266mg single dose for TAP block local injection for postoperative pain control after abdominal surgery.
Droga: oxycodone
Prepared in PCIA pump for intravenous patient-controlled analgesia after abdominal operation.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Area Under Curve (AUC) of I-FEED Score within Postoperative 7 Days
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time-Weighted Average (TWA) of Rest & Movement NRS Pain Score within 72h Postoperatively
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Serum IL-6 and Cortisol Concentrations
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Tianjin First Central Hospital

Investigatori

  • Direttore dello studio: Wenli Yu, Tianjin First Central Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

1 settembre 2026

Completamento dello studio (Stimato)

1 settembre 2026

Date di iscrizione allo studio

Primo inviato

5 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

10 giugno 2026

Primo Inserito (Effettivo)

16 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • TJH-2026-99

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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