Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: 266 mg (20 mL) diluted with 10 mL normal saline to total 30 mL; infiltrated at six perianal positions at end of surgery
Ropivacaine Hydrochloride: 200 mg (20 mL) diluted with 10 mL normal saline to total 30 mL; infiltrated at six perianal positions at end of surgery
Study summary
This is a single-center, prospective, randomized, double-blind controlled trial comparing the analgesic efficacy, quality of recovery, and safety of perianal wound infiltration with multivesicular liposomal bupivacaine (266 mg) versus ropivacaine hydrochloride (200 mg) in patients undergoing Milligan-Morgan open hemorrhoidectomy under spinal anesthesia. Both solutions are diluted to a total volume of 30 mL and infiltrated at six predefined perianal positions at the end of surgery. The primary outcome is the resting visual analog scale (VAS) pain score at 24 hours after surgery. Secondary outcomes include resting and movement-evoked VAS pain scores at 4, 6, 12, 24, and 48 hours, cumulative rescue analgesic consumption during postoperative days 1-3, Quality of Recovery-40 (QoR-40) scores on postoperative days 1-3, and adverse events within 72 hours after surgery.
Eligibility
Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria:
* 1\. Aged 18-60 years, irrespective of sex 2. Diagnosed with grade III-IV internal hemorrhoids or mixed hemorrhoids based on specialist examination and scheduled to undergo elective Milligan-Morgan open hemorrhoidectomy 3. American Society of Anesthesiologists (ASA) physical status I-III 4. Body mass index (BMI) of 18.0-30.0 kg/m² 5. Able to understand and complete the pain and quality-of-recovery assessments and willing to participate in the study
Exclusion Criteria:
1\. Concomitant chronic low back or leg pain, anal fissure, perianal abscess, or other persistent painful conditions 2. Pregnancy, breastfeeding, or plans to become pregnant in the near future 3. Known allergy to bupivacaine, ropivacaine, or any other medication used during the study 4. Long-term regular use of opioids or use of analgesic medications within 48 hours before surgery 5. Obstructive sleep apnea syndrome or severe cardiovascular, cerebrovascular, or pulmonary disease considered to significantly increase risks associated with neuraxial anesthesia or postoperative analgesia 6. Psychiatric or cognitive impairment that precludes completion of study assessments 7. Any other condition that, in the investigator's judgment, renders the patient unsuitable for participation
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Primary outcome measure(s)
Resting visual analog scale (VAS) pain score — 48 hours after surgery Pain intensity at rest assessed using a 10-cm VAS, with 0 indicating no pain and 10 indicating the worst imaginable pain.
Trial sites (1)
Facility
City
Region
Status
Tongliao People's Hospital
Neimeng
Tongliao
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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