The Efficacy and Safety of Liposomal Bupivacaine in Relieving Postoperative Pain After Hemorrhoid Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorBeijing Tiantan Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients scheduled for elective Hemorrhoid Surgery under general anesthesia;
Ages 18 to 64 years old；
American Society of Anesthesiologists (ASA) physical status of I-III；
Glasgow Coma Scale (GCS) score of 15；
Disqualifiers
History of chronic pain syndrome of any cause.
Patients with heart conduction block (sinus block or atrioventricular block).
Patients with unstable coronary artery disease.
Patients with gastric ulcer or gastric bleeding.
Trial design
Design model
Parallel
Treatments tested in this trial
Bupivacaine hydrochloride
Drug30 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.
Liposomal bupivacaine plus bupivacaine
DrugAt 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.
Treatment groups
156 Participants
are divided into 2 treatment groupsGroup A: Bupivacaine hydrochloride groupActive comparator 1 intervention
Group B: Liposomal Bupivacaine plus Bupivacaine hydrochloride groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively
Time frame
The postoperative period 48 hours.Secondary outcomes
1
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.2
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 3.3
Time to request of first analgesia
Time frame
Within 48 hours postoperatively.4
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.Sponsors and contacts
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Source ClinicalTrials.gov