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Effect of bupivacaine liposomes for transversus abdominis fascia block on the efficacy of labor analgesia after robot-assisted laparoscopic total hysterectomy: a randomized, prospective, controlled study

Effect of bupivacaine liposomes for transversus abdominis fascia block on the efficacy of labor analgesia after robot-assisted laparoscopic total hysterectomy: a randomized, prospective, controlled study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082615
Enrollment
Unknown
Registered
2024-04-01
Start date
2024-04-01
Completion date
Unknown
Last updated
2024-04-08

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

Conditions

Postoperative pain

Interventions

Experimental group:After anesthesia induction, ultrasound-guided bilateral transverse abdominal muscle fascia block was performed. The local anesthetic was 266 mg (40ml) of bupivacaine liposome and 20
Control group:After anesthesia induction, ultrasound-guided bilateral transverse abdominal muscle fascia block was performed. The local anesthetic was 100 mg (40ml) of bupivacaine injection and 20ml o

Sponsors

Cangzhou Hospital of Integrated Chinese and Western Medicine, Hebei Province
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Have fully understood the study and voluntarily signed the informed consent; 2) Over 18 years old (inclusive), under 65 years old (inclusive); 3) American Society of Anesthesiologists (ASA) grade I-II, and are willing to use the study's uniform anesthesia protocol during surgery; 4) To undergo robot-assisted laparoscopic total hysterectomy under general anesthesia; 5) Body mass index (BMI) = weight (kg)/height 2 (m2), 18=BMI=30.

Exclusion criteria

Exclusion criteria: 1) Patients who need to undergo surgery of different types or parts during the same period of surgery; 2) Those who have significant pain other than the expected surgical pain, or who have a neurological, mental or intellectual disorder that prevents them from correctly describing their feelings or understanding pain scale scores, or who have other disorders that interfere with pain assessment; 3) Patients with postoperative hypovolemia or intraoperative bleeding =400 mL; 4) dehydration caused by any reason other than fasting and water prohibition before operation; 5) Have any of the following medical conditions that the investigator determines may limit participation in the study: for example, a serious infection that is active or poorly controlled clinically; Uncontrolled arterial hypertension (systolic blood pressure =160 mmHg, and/or diastolic blood pressure =105 mmHg during the screening period) even with standard treatment; Patients with hypotension (systolic blood pressure =90 mmHg during screening period); Diabetes mellitus whose blood glucose was not satisfactorily controlled (fasting blood glucose =11.1mmol/L during the screening period); 6) Complicated with viral hepatitis, severe active liver disease, abnormal liver function (ALT and/or AST>1.5 times the upper limit of normal or total bilirubin =1.5 times the upper limit of normal), abnormal kidney function (serum creatinine >1.5 times the upper limit of normal or creatinine clearance =30 mL/min), or received dialysis treatment within 28 days before surgery; 7) Patients with high blood risk, including patients with congenital bleeding disorders (such as hemophilia), thrombocytopenia (platelet count <80×109/L), coagulation disorders, clinically significant active bleeding, or patients with a history of diseases related to platelet dysfunction; History of gastrointestinal ulcer and cerebrovascular hemorrhage; 8) Patients with severe cardiovascular disease (pacemaker installed at screening time, pulmonary heart disease, heart failure, or New York heart disease rating =?), or who were judged by the investigator to have significant abnormalities in electrocardiogram detection at screening time and at baseline; Or other heart function abnormalities judged abnormal by researchers and clinically significant; 9) Patients with a history of head trauma, intracranial surgery, stroke, cerebral arteriovenous malformation, or cerebral aneurysm in the 4 weeks before surgery, or with organic lesions of the central nervous system and disorders of consciousness; 10) Used monoamine oxidase inhibitors, tryptophan, carbamazepine or valproate within 2 weeks before surgery, or used other antidepressants (such as serotonin or norepinephrine reuptake inhibitors, tricyclic antidepressants, etc.) within 3 weeks before surgery; 11) Drugs that may affect the metabolism or toxicity of the studied drug should be used during the study, such as drugs that induce or regulate the liver cytochrome enzyme CYP2E1, antiviral drugs zidovudine, etc.; 12) A history of drug abuse or alcohol abuse, defined as drinking more than 14 units of alcohol per week (1 unit of alcohol =360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine); 13) Participated in other clinical trials within 4 weeks before surgery; 14) Use of opioids within 24 hours before surgery; 15) Patients undergoing surgical conversion; 16) Pregnant and lactating women, or women of childbearing age who have a positive pregnancy test within 7 days befor

Design outcomes

Primary

MeasureTime frame
Total dosage of sufentanil 72 h after operation;

Secondary

MeasureTime frame
Pain scores at rest and exercise 6h, 12h, 24h, 48h and 72h after surgery;Post-operative time at rest and exercise - area under the pain score curve;The total number of times the patient applied the analgesic pump and the effective number of times;The incidence of adverse events;Liver and kidney function;24h, 72 h post-operative Anxiety Scale (GAD Broad Anxiety Scale);

Countries

China

Contacts

Public ContactLimin Zhang

Cangzhou Hospital of Integrated Chinese and Western Medicine, Hebei Province

azai2010@126.com+86 133 4337 9856

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026