Analgesia, Liposomal Bupivacaine, Preperitoneal Infiltration
Conditions
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.
Detailed description
Patients undergoing upper gastrointestinal open surgery often experience moderate to severe postoperative pain, which not only hinders early recovery but also significantly impairs their quality of life. Ideal postoperative analgesia requires a balance between efficacy and safety, and preperitoneal local anesthetic administration serves as an effective strategy to achieve this goal. Compared to conventional local anesthetics, liposomal bupivacaine-as a novel sustained-release formulation-enables continuous drug release, extending the analgesic duration to 48-72 hours. This study aims to compare the postoperative analgesic effects of preperitoneal injection of liposomal bupivacaine versus ropivacaine in patients undergoing upper gastrointestinal open surgery. This study employs a randomized controlled design. Participants will be stratified based on the type of surgical incision (midline or subcostal) and randomized into groups using a computer-generated random seed with permuted block randomization (variable block sizes of 2, 4). Prior to abdominal closure during surgery, the experimental group will receive liposomal bupivacaine injections into the preperitoneal space on both sides of the wound, while the control group will receive ropivacaine injections. Apart from this intervention, both groups will maintain identical protocols for anesthesia induction, maintenance, and postoperative systemic analgesia to accurately evaluate the relative efficacy of the two local analgesic agents.
Interventions
DRUGLiposomal bupivacaine
Prior to abdominal closure, liposomal bupivacaine is administered preperitoneally along the surgical incision and diluted with normal saline according to the incision length.
DRUGropivacaine
Prior to abdominal closure, ropivacaine is administered preperitoneally along the surgical incision and diluted with normal saline to a concentration of 0.3%.
Sponsors
Qilu Hospital of Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants and postoperative outcome assessors were blinded to treatment allocation. Anesthesiologists, postoperative care providers, and statisticians were also blinded. An independent study-drug preparation investigator was aware of the allocation. Because the study drugs differed in appearance, surgeons became aware of the allocation during preperitoneal infiltration at abdominal closure. The surgeons were not involved in postoperative analgesic management, outcome assessment, or data analysis.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18 to 75 years; for those \>70 years old, a Karnofsky Performance Status (KPS) score ≥80 is required. 2. Scheduled for elective upper abdominal laparotomy. 3. Surgical approach involving either a subcostal or midline incision. 4. Incision length between 15 and 30 cm. 5. American Society of Anesthesiologists (ASA) physical status classification of I to III.
Exclusion criteria
1. ASA Physical Status Class greater than III. 2. Pre-existing chronic pain with long-term opioid use (for \>1 year). 3. 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. 4. Known allergy or hypersensitivity to the investigational drug or any of its excipients. 5. Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative pain score（NRS） | Day 1 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Rescue Analgesia and Number of Effective Patient-Controlled Intravenous Analgesia (PCIA) | Day 3 | The PCIA protocol (sufentanil 2 μg/kg in 100 mL saline, no background infusion, 3 mL bolus, 30-min lockout) was used. We recorded the time to first PCIA activation and the cumulative number of effective boluses within the first 72 postoperative hours. |
| the use of flurbiprofen axetil | Day 3 | the amount of rescue analgesic drugs flurbiprofen axetil used |
| postoperative adverse events | The first 3 postoperative days | the incidence of nausea, vomiting, and vertigo after surgery |
| The Richards-Campbell Sleep Questionnaire | day 3 | It uses a 0-100 mm visual analog scale, with higher scores indicating better sleep quality. |
| Quality of Recovery-15 (QOR-15) scale | The first 3 postoperative days | The scores from all 15 questions are summed to yield a total score ranging from 0 to 150, with a higher total score indicating a better quality of recovery for the patient. |
| Overall Benefit of Analgesia Score | The first three postoperative days | This score is a patient-reported outcome measure for comprehensively evaluating the effectiveness of postoperative analgesic regimens, using a 29-point scale from 0 (best) to 28 (worst). |
| Changes in postoperative pain | The first 3 postoperative days | Changes in pain scores (NRS) within the first 3 days postoperatively, including scores at rest at 6, 12, 24, 48, and 72 hours, as well as the peak pain level during this 3-day period. |
| hospital length of stay | From date of hospital admission until the date of discharge,assessed up to 15 days. | The time between hospital admission and discharge |
| C-reactive protein | On the preoperative day and postoperative day 1 | The inflammatory marker of participants will be test after surgery |
| White Blood Cell Count and Differential | Day 1 | By analyzing the WBC profile-including both total count and cell type distribution-the inflammatory condition of a patient can be evaluated. |
| Postoperative Complications | One month after surgery | The probability of patients acquiring pulmonary complications after surgery. |
Countries
China
Outcome results
None listed