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Efficacy and Safety of Bupivacaine Liposome for Incisional Infiltration Block in Postoperative Analgesia of Patients Undergoing Cytoreductive Surgery Combined with Hyperthermic Intraperitoneal Chemotherapy: A Single-Center, Randomized, Double-Blind, Controlled Study

Efficacy and Safety of Bupivacaine Liposome for Incisional Infiltration Block in Postoperative Analgesia of Patients Undergoing Cytoreductive Surgery Combined with Hyperthermic Intraperitoneal Chemotherapy: A Single-Center, Randomized, Double-Blind, Controlled Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100826
Enrollment
Unknown
Registered
2025-04-15
Start date
2025-04-15
Completion date
Unknown
Last updated
2025-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None

Interventions

Experimental Group(PCIA-LB):1. In the abdominal closure stage, after the suturing of the rectus fascia layer, two fixed surgeons will administer bupivacaine liposomal local infiltration block above th
PCA dose: 2-3ml
The interval time is 15-20min
Control Group(PCIA-NS):1. In the abdominal closure stage, after the suturing of the rectus fascia layer, two fixed surgeons will give local infiltration block above and subcutaneously above the rectus

Sponsors

Beijing Tsinghua Changgung Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18~65 years old; 2. Patients who intend to undergo elective CRS-HIPEC surgery 3. Body mass index (BMI): 18~28 kg/m^2; 4. American Society of Anesthesiologists (ASA) grade I.~III.; 5. Postoperative signing of opioid analgesic pumps.

Exclusion criteria

Exclusion criteria: 1. Severe hepatic and renal dysfunction (defined as glomerular filtration rate =1.5); 4. Refusal to participate in this study; 5. History of alcohol or drug abuse; Suffering from mental illness and impaired mental status. 6. Chronic opioid users (more than 3 months of use); Presence of chronic pain (pain lasting more than 3 months)

Design outcomes

Primary

MeasureTime frame
Postoperative three-day NRS movement pain score;

Secondary

MeasureTime frame
Postoperative three-day NRS resting pain score;Morphine equivalent consumption;Effective presses of the analgesic pump;Quality of early postoperative recovery (QoR-15);Number of rescue analgesia administrations within 72 hours postoperatively;Patient satisfaction with analgesia; Adverse reactions during analgesic therapy (respiratory depression, dizziness, nausea and vomiting, pruritus, urinary retention, etc.;Postoperative adverse events;

Countries

China

Contacts

Public ContactZhang Huan

Beijing Tsinghua Changgung Hospital

zha00558@163.com+86 10 5611 9367

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 3, 2026