Hemorrhoids
Conditions
Interventions
Experimental Group:Perianal subcutaneous multi-layer infiltration using bupivacaine liposome injection.
Control Group:Identical infiltration technique with a mixture of: Lidocaine (200 mg, 10 mL) + Normal saline (20 mL)
Sponsors
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–65 years, male or female. 2. Body mass index (BMI) 19–30 kg/m^2. 3. Clinical diagnosis of mixed hemorrhoids and scheduled to undergo 2–3-incision external hemorrhoidectomy with internal ligation (Milligan-Morgan technique). 4. American Society of Anesthesiologists (ASA) Physical Status Classification I–III. 5. Willing to receive postoperative analgesia. 6. Able to fully understand the nature, significance, potential benefits, and risks of the trial; comprehend the study procedures and methods; commit to strict compliance with the clinical trial protocol; and voluntarily provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women, or patients planning pregnancy within six months unwilling/unable to use effective contraception. 2. Sensory disorders (e.g., hyperalgesia) or pre-existing chronic pain that may interfere with postoperative pain assessment. 3. History of myocardial infarction/unstable angina within the past 6 months, or severe arrhythmias (e.g., second-degree or higher atrioventricular block). 4. Abnormal liver function:AST and/or ALT >= 2.5 × ULN (upper limit of normal); Total bilirubin (TBIL) >= 1.5 × ULN 5. Abnormal renal function:Blood urea nitrogen (BUN) > 1.5 × ULN; Serum creatinine > ULN 6. Use of antidepressants or glucocorticoids within 3 days prior to surgery. 7. History of alcohol abuse (>=2 standard drinks/day) or drug abuse within the past 2 years:1 standard drink = 360 mL beer / 45 mL 40% spirits / 150 mL wine 8. Known allergy or contraindication to bupivacaine or other amide-type local anesthetics. 9. Any other condition deemed unsuitable for trial participation by the investigator. 10. Current participation in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The cumulative pain score at rest within 72 hours after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to first postoperative defecation;Pain score at first defecation;Time to first rescue analgesic administration;Incidence and total frequency of rescue analgesia during hospitalization;Types and dosages of rescue analgesics used during hospitalization;Sleep satisfaction score (0–10);Quality of Recovery-15 (QoR-15) score;Pain score (NRS-D8) on postoperative day 8 (±2 days); | — |
Countries
China
Contacts
Public ContactZhen De
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed