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Bupivacaine liposomal injection for acute pain after hemorrhoidectomy

Efficacy and safety of bupivacaine liposomal injection for acute pain after hemorrhoidectomy: a national multicenter, ambispective, cohort study

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400088883
Enrollment
Unknown
Registered
2024-08-28
Start date
2024-07-02
Completion date
Unknown
Last updated
2024-09-02

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

Conditions

Haemorrhoidectomy

Interventions

Retrospective cohort:none
Prospective cohort:none

Sponsors

Nanjing Traditional Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: Prospective cohort: 1. Voluntarily sign informed consent; 2. Patients with mixed hemorrhoids undergoing elective hemorrhoidectomy; 3. Age =18 years old; 4. American Society of Anesthesiologists (ASA) grade ?~?. Retrospective cohort: 1. Patients with mixed hemorrhoids undergoing hemorrhoidectomy; 2. Use of bupivacaine liposome injection or other analgesic regimens for postoperative acute pain; 3. Age =18 years old, regardless of gender.

Exclusion criteria

Exclusion criteria: Prospective cohort: 1. Patients with comorbid mental disorders and cognitive impairment; 2. Patients with sensory disorders such as hyperalgesia, or other bodily pain affecting postoperative pain assessment; 3. The history of myocardial infarction, unstable angina pectoris, or severe arrhythmia (such as atrioventricular block of degree ? or above) within 6 months; 4. Patients with diabetic peripheral neuropathy; 5. Abnormal liver function: aspartate aminotransferase (AST) or/and alanine aminotransferase (ALT) and/or total bilirubin (TBIL) =1.5×ULN; 6. Known to be allergic to bupivacaine or other amide local anesthetics; 7. Pregnant and lactating women; 8. Patients with any other factor considered by the investigator to be ineligible for the trial. Retrospective cohort: 1. Patients with concurrent pain in other parts of the body other than the surgical site, or patients with chronic pain; 2. Patients with missing data information related to key studies.

Design outcomes

Primary

MeasureTime frame
The proportion of patients with NRS score =3 at rest within 72 hours after the end of surgery;

Secondary

MeasureTime frame
NRS scores in resting/active state within 72 hours after surgery were recorded;Maximum pain intensity score during each defecation change within 3 days after surgery;Maximum pain intensity score during each dressing change within 3 days after surgery;Opioid consumption (as intravenous morphine equivalent) within 72 hours after the end of surgery;Time to first receipt of rescue analgesic within 72 hours after the end of surgery;Number of rescue analgesic administered within 72 hours after the end of surgery;The Quality of Recovery scale (QoR-15) was used to evaluate the quality of recovery at 24h and 72h after operation;Length of Stay;Opioid consumption (as intravenous morphine equivalent) within 72 hours after the end of surgery;

Countries

China

Contacts

Public ContactYang Zhang

Nanjing Traditional Chinese Medicine Hospital

21670235@qq.com+86 131 8283 5012

Outcome results

None listed

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