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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group（Ropivacaine + Sufentanil） | Active Comparator | TAP block with 0.375% Ropivacaine + PCIA Sufentanil for postoperative analgesia after abdominal surgery |
|
| Experimental Group 1（Liposomal Bupivacaine + Sufentanil） | Experimental | TAP block with Liposomal Bupivacaine 266mg + PCIA Sufentanil for postoperative analgesia after abdominal surgery |
|
| Experimental Group 2（Liposomal Bupivacaine + Oxycodone） | Experimental | TAP block with Liposomal Bupivacaine 266mg + PCIA Oxycodone for postoperative analgesia after abdominal surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ropivacaine hydrochloride | Drug | 0.375% solution for transversus abdominis plane (TAP) local injection during surgery for postoperative analgesia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under Curve (AUC) of I-FEED Score within Postoperative 7 Days | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time-Weighted Average (TWA) of Rest & Movement NRS Pain Score within 72h Postoperatively | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum IL-6 and Cortisol Concentrations | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ke yu Zhang | Contact | +86 19861121816 | m456365zky@163.com | |
| Yu | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Wenli Yu | Tianjin First Central Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin First Central Hospital | Recruiting | Tianjin | Tianjin Municipality | 300384 | China |
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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| Liposomal bupivacaine (LB) | Drug | 266mg single dose for TAP block local injection for postoperative pain control after abdominal surgery. |
|
| Sufentanil citrate | Drug | Formulated into PCIA pump for continuous intravenous infusion for postoperative patient-controlled analgesia. |
|
| oxycodone | Drug | Prepared in PCIA pump for intravenous patient-controlled analgesia after abdominal operation. |
|
| TWA of Short-form McGill Pain Questionnaire 2 (SF-MPQ-2) Score within Postoperative 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 | 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) | 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 | 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) | 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 | 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 | 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 |
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 | Determine plasma β-endorphin level to explore central pain modulation mechanism of multimodal analgesia. | End of surgery, Postoperative Day1, Postoperative Day2 |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D017409 | Sufentanil |
| D010098 | Oxycodone |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
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