A Phase 4 interventional study of Liposomal Bupivacaine (EXPAREL®)/Bupivacaine and Ropivacaine Hydrochloride in Resting Visual Analog Scale (VAS) Pain Score, sponsored by Tongliao City People's Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Tongliao City People's Hospital · Phase 4, Interventional, and Treatment
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.
Milligan-Morgan open hemorrhoidectomy is associated with substantial postoperative pain due to rich somatic innervation of the perianal region, wound exposure, anal sphincter spasm, and stimulation during defecation. Optimizing postoperative analgesia is critical for enhanced recovery. Local wound infiltration with ropivacaine is commonly used but provides limited duration of analgesia. Liposomal bupivacaine, formulated with a multivesicular liposomal delivery system, enables sustained release of bupivacaine at the injection site and may prolong local analgesia. However, high-quality comparative evidence between liposomal bupivacaine and ropivacaine for wound infiltration after open hemorrhoidectomy remains limited.
This single-center, prospective, randomized, double-blind controlled trial enrolled patients aged 18-60 years with grade III-IV internal hemorrhoids or mixed hemorrhoids scheduled for elective Milligan-Morgan open hemorrhoidectomy at Tongliao People's Hospital between November 2025 and May 2026. Patients were randomized 1:1 to receive perianal wound infiltration with either 266 mg of liposomal bupivacaine or 200 mg of ropivacaine hydrochloride, both diluted to 30 mL with normal saline and divided into six 5-mL aliquots infiltrated at six predefined perianal clock-face positions. All patients received spinal anesthesia with 15 mg of 0.5% hyperbaric bupivacaine. Rescue analgesia with oral diclofenac sodium 50 mg was provided when VAS pain score was ≥4.
The primary outcome is resting VAS pain score at 24 hours postoperatively. Secondary outcomes include resting and movement-evoked VAS pain scores at 4, 6, 12, 24, and 48 hours, cumulative diclofenac sodium consumption during postoperative days 1-3, QoR-40 total scores on postoperative days 1-3, and adverse events (nausea and vomiting, rash, lower-extremity numbness or weakness, local anesthetic systemic toxicity, perianal hematoma, surgical-site infection) within 72 hours.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 140 is above the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →This is the only study on the registry with Tongliao City People's Hospital as lead sponsor.
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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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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive perianal wound infiltration with 266 mg of multivesicular liposomal bupivacaine (20 mL) diluted with 10 mL normal saline to a total volume of 30 mL. The 30-mL solution is divided into six 5-mL aliquots and evenly infiltrated at six predefined perianal clock-face positions along the wound margins and adjacent tissues immediately after completion of surgery.
Drug: Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
Patients receive perianal wound infiltration with 200 mg of ropivacaine hydrochloride (20 mL) diluted with 10 mL normal saline to a total volume of 30 mL. The 30-mL solution is divided into six 5-mL aliquots and evenly infiltrated at six predefined perianal clock-face positions along the wound margins and adjacent tissues immediately after completion of surgery.
Drug: Ropivacaine Hydrochloride
Drug page: Liposomal Bupivacaine
266 mg (20 mL) diluted with 10 mL normal saline to total 30 mL; infiltrated at six perianal positions at end of surgery
200 mg (20 mL) diluted with 10 mL normal saline to total 30 mL; infiltrated at six perianal positions at end of surgery
Resting visual analog scale (VAS) pain score
Pain intensity at rest assessed using a 10-cm VAS, with 0 indicating no pain and 10 indicating the worst imaginable pain.
Time frame: 48 hours after surgery
Resting and movement-evoked VAS pain scores
Pain intensity at rest and during movement assessed using a 10-cm VAS at predefined postoperative time points.
Time frame: 4, 6, 12, 24, and 48 hours after surgery
Cumulative rescue analgesic consumption
Cumulative dose of oral diclofenac sodium (mg) consumed as rescue analgesia when VAS pain score ≥4. Maximum daily dose 150 mg, minimum interval 8 hours
Time frame: Postoperative days 1-3 (within 72 hours)
Quality of Recovery-40 (QoR-40) total score
The QoR-40 comprises 40 items across five dimensions (physical comfort, emotional state, physical independence, psychological support, and pain). Total scores range from 40 to 200, with higher scores indicating better postoperative recovery.
Time frame: Postoperative days 1, 2, and 3
Incidence of adverse events
Adverse events including nausea and vomiting, rash, lower-extremity numbness or weakness, local anesthetic systemic toxicity, perianal hematoma, and surgical-site infection
Time frame: Within 72 hours after surgery
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — The datasets generated during this study are available from the corresponding author upon reasonable request by email.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Following publication of the primary manuscript
Access criteria: Reasonable request by email to the corresponding author
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Studies of the drug tested here: Liposomal Bupivacaine