Postoperative PainNCT07651722
Effect of Liposomal Bupivacaine TAPB Combined With Oxycodone PCIA on Postoperative Gastrointestinal Recovery in Patients Undergoing Major Abdominal Surgery
A study testing ropivacaine hydrochloride, Liposomal bupivacaine (LB) and Sufentanil citrate in people with Postoperative Pain and Postoperative Ileus, run by Tianjin First Central Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain, Postoperative Ileus
- What is being tested?
- ropivacaine hydrochloride, Liposomal bupivacaine (LB) and Sufentanil citrate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 16 Jun 2026to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yu contact
China1 site, 1 recruiting
- Recruiting
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, 300384
Wenli Yu, +86 139 2009 8326, yzxyuwenli@163.com
About this study
Official title: 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.
Read more
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
- Conditions
- Postoperative Pain, Postoperative Ileus
- Being tested
- ropivacaine hydrochloride, Liposomal bupivacaine (LB), Sufentanil citrate, oxycodone
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropivacaine hydrochlorideDrug
0.375% solution for transversus abdominis plane (TAP) local injection during surgery for postoperative analgesia.
Liposomal bupivacaine (LB)Drug
266mg single dose for TAP block local injection for postoperative pain control after abdominal surgery.
Sufentanil citrateDrug
Formulated into PCIA pump for continuous intravenous infusion for postoperative patient-controlled analgesia.
oxycodoneDrug
Prepared in PCIA pump for intravenous patient-controlled analgesia after abdominal operation.
| Study group | Role | What they receive |
|---|---|---|
| Control Group（Ropivacaine + Sufentanil） | Active comparator | TAP block with 0.375% Ropivacaine + PCIA Sufentanil for postoperative analgesia after abdominal surgery Receives: Drug: ropivacaine hydrochloride; Drug: Sufentanil citrate |
| Experimental Group 1（Liposomal Bupivacaine + Sufentanil） | Experimental | TAP block with Liposomal Bupivacaine 266mg + PCIA Sufentanil for postoperative analgesia after abdominal surgery Receives: Drug: Liposomal bupivacaine (LB); Drug: Sufentanil citrate |
| Experimental Group 2（Liposomal Bupivacaine + Oxycodone） | Experimental | TAP block with Liposomal Bupivacaine 266mg + PCIA Oxycodone for postoperative analgesia after abdominal surgery Receives: Drug: Liposomal bupivacaine (LB); Drug: oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative Day 1 to Postoperative Day 7
Secondary outcomes (8)
Time-Weighted Average (TWA) of Rest & Movement NRS Pain Score within 72h Postoperatively
Postoperative 6h,12h,24h,48h,72h
Measured: 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
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.
Measured: 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.
Measured: 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。
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Postoperative Day 1 - Day7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start16 Jun 2026
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin First Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenli Yu, Tianjin First Central Hospital
- Investigators
- Wenli Yu, Study director, Tianjin First Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07651722
- Sponsor's protocol ID
- TJH-2026-99
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Liposomal Bupivacaine TAPB Combined With Oxycodone PCIA on Postoperative Gastrointestinal Function in Patients Undergoing Major Abdominal Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07651722
- Acronym / sponsor ID
- TJH-2026-99
- Conditions
- Postoperative Pain, Postoperative Ileus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Tianjin First Central HospitalUniversity, hospital or other
- Study start
- 16 Jun 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group（Ropivacaine + Sufentanil） | Active comparator | Drug: ropivacaine hydrochloride, Drug: Sufentanil citrateTAP block with 0.375% Ropivacaine + PCIA Sufentanil for postoperative analgesia after abdominal surgery |
| Experimental Group 1（Liposomal Bupivacaine + Sufentanil） | Experimental | Drug: Liposomal bupivacaine (LB), Drug: Sufentanil citrateTAP block with Liposomal Bupivacaine 266mg + PCIA Sufentanil for postoperative analgesia after abdominal surgery |
| Experimental Group 2（Liposomal Bupivacaine + Oxycodone） | Experimental | Drug: Liposomal bupivacaine (LB), Drug: oxycodoneTAP block with Liposomal Bupivacaine 266mg + PCIA Oxycodone for postoperative analgesia after abdominal surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ropivacaine hydrochloride0.375% solution for transversus abdominis plane (TAP) local injection during surgery for postoperative analgesia. | Drug | Control Group（Ropivacaine + Sufentanil） |
| Liposomal bupivacaine (LB)266mg single dose for TAP block local injection for postoperative pain control after abdominal surgery. | Drug | Experimental Group 1（Liposomal Bupivacaine + Sufentanil）, Experimental Group 2（Liposomal Bupivacaine + Oxycodone） |
| Sufentanil citrateFormulated into PCIA pump for continuous intravenous infusion for postoperative patient-controlled analgesia. | Drug | Control Group（Ropivacaine + Sufentanil）, Experimental Group 1（Liposomal Bupivacaine + Sufentanil） |
| oxycodonePrepared in PCIA pump for intravenous patient-controlled analgesia after abdominal operation. | Drug | Experimental Group 2（Liposomal Bupivacaine + Oxycodone） |
Primary outcome
Area Under Curve (AUC) of I-FEED Score within Postoperative 7 Days
Time frame: 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.
8 secondary outcomes
Time-Weighted Average (TWA) of Rest & Movement NRS Pain Score within 72h Postoperatively
Time frame: 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
Time frame: Postoperative 24h,48h,72h
Total opioid dose (morphine equivalent) within 72 hours postoperatively
Time frame: 0-72 hours after surgery
Incidence of Prolonged Postoperative Ileus (PPOI)
Time frame: Within postoperative 7 days
First Flatus & First Defecation Time
Time frame: 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)
Time frame: 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
Time frame: Postoperative day 1，Postoperative day 2 ，Postoperative day 3
Incidence of Postoperative Adverse Events
Time frame: Postoperative Day 1 - Day7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yu contact
Wenli Yu study director
Tianjin First Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ropivacaine hydrochloride, Liposomal bupivacaine (LB) and Sufentanil citrate in people with Postoperative Pain and Postoperative Ileus, run by Tianjin First Central Hospital 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 4 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: looking for participants now, as of the sponsor's last update on 25 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ke yu Zhang (+86 19861121816, m456365zky@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under Curve (AUC) of I-FEED Score within Postoperative 7 Days (time frame: Postoperative Day 1 to Postoperative Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2026.