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Randomized, double-blind, parallel controlled clinical study on analgesic effect evaluation of bupivacaine liposome injection with different doses after hemorrhoidectomy

Randomized, double-blind, parallel controlled clinical study on analgesic effect evaluation of bupivacaine liposome injection with different doses after hemorrhoidectomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094323
Enrollment
Unknown
Registered
2024-12-20
Start date
2024-12-30
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

combined hemorroid

Interventions

Experimental group :Using bupivacaine liposome injection at a dose of 4mg/kg, diluted with physiological saline to a total volume of 30ml, and then injected 5ml layer by layer at each site
control group:20ml of bupivacaine liposome injection was used, diluted with 10ml of physiological saline to a total volume of 30ml, and 5ml was injected layer by layer at each site

Sponsors

Wenjiang District People's Hospital of Chengdu
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) 18 ~ 65 years old, regardless of sex; Weight <=66.5kg. 2) It meets the relevant diagnostic criteria of mixed hemorrhoids and has clear surgical indications; 3) Subjects voluntarily sign written informed consent;

Exclusion criteria

Exclusion criteria: 1) Patients with serious primary diseases before operation, such as cardiovascular and cerebrovascular diseases, malignant tumors, hematological diseases and abnormal liver and kidney functions; 2) Patients with other anorectal diseases, such as perianal abscess, anal fistula and ulcerative colitis; 3) mental and neurological diseases or severe decline in self-care ability; 4) Those who are known to have allergic history to drugs with similar components and chemical structures in the study drugs or control drugs; 5) Pregnant, quasi-pregnant or lactating women; 6) Other circumstances judged by the researcher as unsuitable for participating in clinical research.

Design outcomes

Primary

MeasureTime frame
Resting state pain score;

Secondary

MeasureTime frame
Anal Edema Score;Anal Control Score;Insomnia score;

Countries

China

Contacts

Public ContactLiu Xu

Wenjiang District People's Hospital of Chengdu

2687358388@qq.com+86 181 1309 1037

Outcome results

None listed

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