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Clinical Study on the Efficacy and Safety of Bupivacaine Liposomes versus Bupivacaine in Local Infiltration Analgesia for Postoperative Incision Pain in Cesarean Section Patients

Clinical Study on the Efficacy and Safety of Bupivacaine Liposomes versus Bupivacaine in Local Infiltration Analgesia for Postoperative Incision Pain in Cesarean Section Patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118797
Enrollment
Unknown
Registered
2026-02-11
Start date
2026-02-28
Completion date
Unknown
Last updated
2026-02-16

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

Conditions

Postoperative cesarean section patients

Interventions

experimental group:Experimental group: At the end of surgery, when closing the abdomen to the subcutaneous fascia layer, 266mg of bupivacaine liposomes (diluted to 40ml with 0.9% sodium chloride solut
control group:Control group: 150mg of bupivacaine (diluted to 40ml with 0.9% sodium chloride solution) was administered during the same period for local infiltration anesthesia at the incision site us

Sponsors

Ningjin County People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Adult parturients aged >= 18 years old; 2. American Society of Anesthesiologists (ASA) classification I-II; 3. Single pregnancy, gestational age >= 37 weeks (full-term); 4. Perform elective or emergency cesarean section surgery; 5. Voluntarily participate in this study, fully understand the research content, and sign a written informed consent form.

Exclusion criteria

Exclusion criteria: 1. Allergic to amide local anesthetics; 2. Severe complications during pregnancy (such as severe preeclampsia, HELLP syndrome, placental abruption and massive bleeding, etc.); 3. Severe liver and kidney dysfunction; 4. Long term use of opioid analgesics or drug abuse; 5. There is active infection at the surgical incision site; 6. Cognitive impairment, unable to cooperate with pain assessment.

Design outcomes

Primary

MeasureTime frame
Area under the NRS score curve for resting pain within 72 hours after surgery (AUC);Cumulative total opioid consumption (milligrams of morphine equivalent, MUC) within 0-72 hours after surgery;

Secondary

MeasureTime frame
NRS scores during rest and activity at each time point;First pain relief time;Opioid consumption at different time periods;patient satisfaction;First time getting out of bed after surgery;Intestinal function recovery time;First successful breastfeeding time;length of hospital stay;

Countries

China

Contacts

Public ContactZhigang Zhang

Ningjin County People's Hospital

doctor22g@126.com+86 135 7349 7356

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026