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Multicenter, Randomized, Double-Blind, Active-Controlled Clinical Study on the Use of Bupivacaine Liposome Injection for Post-Hemorrhoidectomy Analgesia

Multicenter, Randomized, Double-Blind, Active-Controlled Clinical Study on the Use of Bupivacaine Liposome Injection for Post-Hemorrhoidectomy Analgesia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098731
Enrollment
Unknown
Registered
2025-03-13
Start date
2024-01-04
Completion date
Unknown
Last updated
2025-03-17

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

Conditions

mixed hemorrhoids

Interventions

Experimental group:After using 20ml of bubicaine liposome injection, adding 10ml of physiological saline to dilute into a total amount of 30ml, 5ml is injected layer by layer at each point
Control group:Use 30ml of physiological saline, and 5ml of layer-by-layer infiltration and injection at each point.

Sponsors

The Third Affiliated Hospital of Henan University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.18 to 65 years old, regardless of gender; 2. Meet the diagnostic criteria related to mixed hemorrhoids and have clear surgical instructions; 3.The subject voluntarily signed a written informed consent form;

Exclusion criteria

Exclusion criteria: 1. Those who have serious preoperative primary diseases, such as cardiovascular and cerebrovascular diseases, malignant tumors, blood diseases, and abnormal liver and kidney function; 2. Patients with other anal diseases, such as perianal abscess, anal fistula, ulcerative colitis, etc.; 3. People with psychoneurological diseases or serious decline in their ability to take care of themselves; 4. Those who are known to have a history of allergy to drugs with similar ingredients and chemical structures contained in research drugs or control drugs; 5. Pregnant, pregnanted or lactating women; 6. Other situations that researchers judge as inappropriate to participate in clinical research.

Design outcomes

Primary

MeasureTime frame
visual analogue scale;Edema score;Insomnia score;Clinical efficacy;

Secondary

MeasureTime frame
Operation time;Hospitalization time;Wound healing time;

Countries

China

Contacts

Public ContactLiu Dianwen

The Third Affiliated Hospital of Henan University of Traditional Chinese Medicine

505437246@qq.com+86 166 3807 9558

Outcome results

None listed

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