An interventional study of Bupivacaine hydrochloride and Liposomal bupivacaine plus bupivacaine in Hemorrhoid Surgery, Liposome Bupivacaine and Pain Management, sponsored by Beijing Tiantan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-03-06.
Sponsored by Beijing Tiantan Hospital · Not applicable, Interventional, and Treatment
Hemorrhoids represents the most prevalent condition among anorectal disorders. Due to the unique anatomical characteristics of the perianal region, patients frequently experience severe postoperative pain, which may lead some individuals to delay treatment due to pain-related anxiety. Consequently, effective postoperative pain management is critical for the recovery of hemorrhoid patients. Developing a simplified, efficient, and safe analgesic approach to alleviate postoperative pain has become an urgent issue in perioperative care. Multimodal analgesia regimens recommend the combined use of local anesthetics to synergistically reduce perioperative pain intensity. However, the primary limitation of this analgesic modality lies in the relatively short duration of action following a single injection of local anesthetic.Liposomal bupivacaine is an innovative long-acting, extended-release amide-type local anesthetic that provides analgesic efficacy for up to 72 hours. However, its efficacy and safety for local infiltration analgesia following hemorrhoid surgery have not been fully validated. Against this backdrop, the present study aims to evaluate and compare the clinical outcomes and safety profile of liposomal bupivacaine versus conventional bupivacaine for postoperative pain management via local infiltration in patients undergoing Hemorrhoid surgery.
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Drug: Bupivacaine hydrochloride
Drug: Liposomal bupivacaine plus bupivacaine
30 mL of 0.25% bupivacaine (75 mg, diluted in normal saline) was administered as a perianal infiltration at the conclusion of the surgical procedure. Using a 22-gauge needle, the solution was injected in a fan-shaped pattern into the perianal tissues.The PCA solution is prepared by diluting 100 μg of sufentanil and 16 mg of ondansetron with normal saline to a total volume of 100 mL. Postoperatively, the patient may press the demand button for analgesia. Each activation delivers a 2 mL bolus, with a lockout interval of 10 minutes.If analgesia remains inadequate after four consecutive demands, one Oxycodone and Acetaminophen Tablets (containing 5 mg oxycodone hydrochloride and 325 mg acetaminophen) is administered orally, with a minimum interval of 6 hours between repeated administrations. If pain persists, intravenous morphine 5 mg may be administered at intervals no shorter than 4 hours.
At the conclusion of the surgical procedure, perianal infiltration was administered with 30 mL of local anesthetic. Using a 22-gauge needle, the solution was injected in a fan-shaped.The local anesthetic is prepared by mixing 20 mL (266 mg) of liposomal bupivacaine with 20 mL of 0.25% bupivacaine and extracting a volume of 30 mL.The PCA solution is prepared by diluting 100 μg of sufentanil and 16 mg of ondansetron with normal saline to a total volume of 100 mL. Postoperatively, the patient may press the demand button for analgesia. Each activation delivers a 2 mL bolus, with a lockout interval of 10 minutes.If analgesia remains inadequate after four consecutive demands, one Oxycodone and Acetaminophen Tablets (containing 5 mg oxycodone hydrochloride and 325 mg acetaminophen) is administered orally, with a minimum interval of 6 hours between repeated administrations. If pain persists, intravenous morphine 5 mg may be administered at intervals no shorter than 4 hours.
Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively
Time frame: The postoperative period 48 hours.
Area Under the Curve (AUC) of Numeric Rating Scale at rest (NRSr) Within 0-72 Hours Postoperatively
The Numeric Rating Scale (NRS) designates 0 as representing no pain and 10 as representing the most severe pain; scores of 1-3 indicate mild pain, 4-6 denote moderate pain, and 7-10 signify severe pain.
Time frame: Data will be collected at 2 hours, 24 hours, 48 hours, and 72 hours postoperatively.
Numeric Rating Scale at rest (NRSr) at 1 week, 1 month, and 3 months postoperatively
The Numeric Rating Scale (NRS) designates 0 as representing no pain and 10 as representing the most severe pain; scores of 1-3 indicate mild pain, 4-6 denote moderate pain, and 7-10 signify severe pain.
Time frame: Postoperative day 7, month 1, and month 3.
Time to request of first analgesia
Time frame: Within 48 hours postoperatively.
Cumulative sufentanil dose for four separate periods (0-4, 4-8, 8-24, and 24-48 h), a total press count including both valid and invalid presses
Time frame: Postoperative Hours 4, 8, 24, and 48.
Duration days of Oral Oxycodone and Acetaminophen Tablets Administration
Time frame: Within 3 months postoperatively.
Patient Satisfaction Scale，PSS
Patient Satisfaction Scale(PSS) on a scale ranging from 0 to 10, where 0 denotes "completely dissatisfied" and 10 signifies "extremely satisfied."
Time frame: Postoperative hours 2, 24, 48, and 72; week 1; month 1; and month 3.
Ramsay Sedation Scale，RSS
The RSS utilizes a six-point scale to evaluate sedation levels. The total score ranges from 1 to 6 as follows: anxious or agitated (1 point); oriented, calm, and cooperative (2 points); responsive to commands (3 points); drowsy with brisk response to glabellar tap or loud auditory stimulus (4 points); drowsy with sluggish response to glabellar tap or loud auditory stimulus (5 points)；and drowsy with no response whatsoever（6）points. A score of 1 reflects inadequate sedation, scores of 2 to 4 indicate satisfactory sedation, while scores of 5 to 6 denote oversedation.
Time frame: Postoperative at 2 hours, 24 hours, 48 hours, and 72 hours.
Quality of Recovery-40，QoR-40
The Quality of Recovery-40 (QoR-40) serves as a globally recognized metric for evaluating the quality of recovery. It encompasses five dimensions-emotional state, physical comfort, physiological independence, psychological support, and pain-comprising a total of 40 items, each rated on a 1-5 scoring scale. The overall QoR-40 score ranges from 40 (indicating extremely poor recovery quality) to 200 (representing excellent recovery quality).
Time frame: Postoperative hours 24, 48, and 72.
The duration of stay in the post-anesthesia care unit（PACU）
The time from the end of surgery until the patient regains consciousness and has stable vital signs after extubating and is subsequently transferred back to the ward.
Time frame: The time from the end of surgery until transferred back to the ward.Typically, patients are transferred back to the ward after approximately 30 to 60 minute.
Length of Stay (LOS)
Time frame: Perioperation.
Total hospitalization expenses incurred during the patient's inpatient stay
Time frame: Perioperation.
Postoperative nausea and vomiting，PONV
Time frame: Postoperatively within 72 hours.
Adverse events，AEs
Systemic Toxicity of Local Anesthetics (LAST), localized hematoma, pruritus, hypotension, arrhythmia, delirium, etl.
Time frame: Within 72 hours postoperatively.
Area Under the Curve (AUC) of Numeric Rating Scale at move (NRSm) Pain Intensity Scores During 0-72 Hours Postoperatively
The Numeric Rating Scale (NRS) designates 0 as representing no pain and 10 as representing the most severe pain; scores of 1-3 indicate mild pain, 4-6 denote moderate pain, and 7-10 signify severe pain.
Time frame: Data will be collected at 2 hours, 24 hours, 48 hours, and 72 hours postoperatively.
Numeric Rating Scale during movement (NRSm) at 1 week, 1 month, and 3 months postoperatively
The Numeric Rating Scale (NRS) designates 0 as representing no pain and 10 as representing the most severe pain; scores of 1-3 indicate mild pain, 4-6 denote moderate pain, and 7-10 signify severe pain.
Time frame: Postoperative day 7, month 1, and month 3.
Total dosage of orally oxycodone and acetaminophen tablets
Time frame: Within 3 months postoperatively.
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures and appendices) are available. Derived data supporting the findings of this study are available from the corresponding author Fang Luo on request.
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