Hemorrhoids
Conditions
Interventions
Bupivacaine Liposome Hydrochloride Bupivacaine Combination Group:LB 266mg mixed with 75mg of bupivacaine hydrochloride solution, total 30ml
Control group:Bupivacaine hydrochloride 75 mg, diluted to 30 ml with 0.9% NS
Sponsors
Peking University Shenzhen Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years, BMI 18.0~30.0 kg/m^2, male weight > 50 kg, and non-pregnant/non-breastfeeding female weight > 45 kg; 2. Diagnosed with mixed hemorrhoids and scheduled for hemorrhoidectomy under general anesthesia, with an expected total incision length >= 3 cm. Single hemorrhoid incisions are mostly radial fusiform, approximately 1~2 cm in length; the total incision length is generally 1.5~5 cm (mostly 2~4 cm). A total incision length >= 3 cm indicates the need to treat at least two or more large hemorrhoids, resulting in a relatively large surgical wound and postoperative pain intensity reaching moderate or above (especially severe within 24~48 hours postoperatively). Selecting such patients ensures sufficient pain stimulus intensity to accurately evaluate the analgesic effect of liposomal bupivacaine versus bupivacaine hydrochloride mixture, as referenced in the literature; 3. ASA classification I~III.
Exclusion criteria
Exclusion criteria: 1. Individuals with a history of myocardial infarction, unstable angina, or serious arrhythmias within 6 months prior to randomization; 2. Individuals with a history of drug or alcohol abuse within 1 year prior to randomization (definition of alcohol abuse: average daily alcohol consumption >2 units, 1 unit = 360 mL beer / 45 mL 40% vol spirits / 150 mL wine), or those who consumed alcohol-containing foods or beverages within 24 hours before administration of the study drug; 3. Individuals with psychiatric disorders (such as schizophrenia, depression, etc.) or cognitive impairment; 4. Individuals with other physical pain that may interfere with postoperative pain assessment; 5. Individuals allergic to bupivacaine, other amide local anesthetics, or the medications intended for use during the study, or with any contraindications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The area under the time curve (R-AUC) of resting pain intensity scores (NRS scores) at 4, 8, 12, 24, 36, 48, and 72 hours after local perianal infiltration.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain intensity scores (NRS scores) within 10 minutes after recovery from general anesthesia, before each administration of rescue analgesics, upon leaving the recovery room, and at 4h, 8h, 12h, 24h, 36h, 48h, and 72h after perianal local infiltration;Total opioid consumption (converted to morphine equivalents) at 12, 24, 48, and 72 hours after local perianal infiltration;Time to first use of opioid rescue medication within 72 hours after perianal local infiltration;Postoperative pain intensity score during defecation (NRS score);Postoperative pain relief satisfaction score (0–10 points, 0 being least satisfied, 10 being most satisfied); | — |
Countries
China
Contacts
Public ContactWu Xinhai
Peking University Shenzhen Hospital
Outcome results
None listed