Hemorrhoid Surgery, Liposome Bupivacaine, Local Infiltration, Pain Management
Conditions
Brief summary
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.
Interventions
DRUGBupivacaine hydrochloride
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.
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
1. Patients scheduled for elective Hemorrhoid Surgery under general anesthesia; 2. Ages 18 to 64 years old； 3. American Society of Anesthesiologists (ASA) physical status of I-III； 4. Glasgow Coma Scale (GCS) score of 15； 5. Patients must be able to understand the nature and potential personal consequences of the clinical trial, signing of the informed consent form.
Exclusion criteria
1. History of chronic pain syndrome of any cause. 2. Patients with heart conduction block (sinus block or atrioventricular block). 3. Patients with unstable coronary artery disease. 4. Patients with gastric ulcer or gastric bleeding. 5. Patients with diabetes and are being treated with insulin. 6. Subjects with coagulation dysfunction (prothrombin time or activated partial thromboplastin time is higher than the normal threshold) or patients who are taking oral anticoagulants for other medical reasons and have not stopped it before surgery, such as warfarin or new anticoagulants rivaroxaban or dabigatran. 7. Patients with abnormal liver function: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \> 2× the upper limit of normal (ULN) or total bilirubin (TBIL) ≥ 1.5×ULN. 8. Patients with renal impairment (serum creatinine \> 176 µmol/L) or receiving dialysis treatment within 28 days before surgery. 9. Patients with a history of diagnosed mental illness or currently taking psychotropic medication. 10. Excessive alcohol or drug abuse, chronic opioid use (more than 2 weeks or 3 days per week for more than 1 month), use of drugs with confirmed or suspected sedative or analgesic effects, or use of any painkiller within 24 h before surgery. 11. Pregnancy or breastfeeding. 12. Extreme body mass index (BMI) (\< 15 or \> 35). 13. Participation in another interventional trial that interferes with the intervention or outcome of this trial. 14. Patients with a history of allergy to local anaesthetics or one of the study drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively | The postoperative period 48 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve (AUC) of Numeric Rating Scale at rest (NRSr) Within 0-72 Hours Postoperatively | Data will be collected at 2 hours, 24 hours, 48 hours, and 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. |
| Numeric Rating Scale at rest (NRSr) at 1 week, 1 month, and 3 months postoperatively | Postoperative day 7, month 1, and month 3. | 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 to request of first analgesia | 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 | Postoperative Hours 4, 8, 24, and 48. | — |
| Duration days of Oral Oxycodone and Acetaminophen Tablets Administration | Within 3 months postoperatively. | — |
| Patient Satisfaction Scale，PSS | Postoperative hours 2, 24, 48, and 72; week 1; month 1; and month 3. | Patient Satisfaction Scale(PSS) on a scale ranging from 0 to 10, where 0 denotes "completely dissatisfied" and 10 signifies "extremely satisfied." |
| Ramsay Sedation Scale，RSS | Postoperative at 2 hours, 24 hours, 48 hours, and 72 hours. | 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. |
| Quality of Recovery-40，QoR-40 | Postoperative hours 24, 48, and 72. | 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). |
| The duration of stay in the post-anesthesia care unit（PACU） | 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. | 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. |
| Length of Stay (LOS) | Perioperation. | — |
| Total hospitalization expenses incurred during the patient's inpatient stay | Perioperation. | — |
| Postoperative nausea and vomiting，PONV | Postoperatively within 72 hours. | — |
| Adverse events，AEs | Within 72 hours postoperatively. | Systemic Toxicity of Local Anesthetics (LAST), localized hematoma, pruritus, hypotension, arrhythmia, delirium, etl. |
| Area Under the Curve (AUC) of Numeric Rating Scale at move (NRSm) Pain Intensity Scores During 0-72 Hours Postoperatively | Data will be collected at 2 hours, 24 hours, 48 hours, and 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. |
| Numeric Rating Scale during movement (NRSm) at 1 week, 1 month, and 3 months postoperatively | Postoperative day 7, month 1, and month 3. | 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. |
| Total dosage of orally oxycodone and acetaminophen tablets | Within 3 months postoperatively. | — |
Countries
China
Contacts
CONTACTFang Luo
Outcome results
None listed