A Study of Intramuscular Sebacoyl Dinalbuphine Ester for Post-Hemorrhoidectomy Pain Management

Study Overview
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Brief Summary
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This is a randomized, double blind, placebo-controlled, single dose study to assess the safety, efficacy and pharmacokinetics of intramuscular sebacoyl dinalbuphine ester (SDE) for post-hemorrhoidectomy pain management.

Official Title
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A Randomized, Double Blind, Placebo-Controlled, Single Dose Study to Assess The Safety and Efficacy of Intramuscular Sebacoyl Dinalbuphine Ester (SDE) for Post-Hemorrhoidectomy Pain Management

Conditions
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Analgesia Disorder, Pain

Intervention / Treatment
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* Drug: Sebacoyl Dinalbuphine Ester
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female >= 20 years of age at Screening Scheduled to electively undergo 2 or 3-column excisional hemorrhoidectomy American Society of Anesthesiology Physical Class 1 - 3 Adequate clinical lab values (values of potential clinical concern are detailed in Appendix) or, if abnormal, deemed not clinically significant per the Investigator. Ability and willingness to provide informed consent, adhere to the study visit schedule and complete all study assessments and language specific questionnaires Exclusion Criteria: Body weight less than 40 kg. Concurrent fissurectomy. Subject is pregnant or breastfeeding. Women of childbearing potential must have a negative urine pregnancy test at Baseline. Women of childbearing potential disagree to use an acceptable method of contraception (e.g., hormonal contraceptives, IUD, barrier device or abstinence) throughout the study. History of hypersensitivity or allergy to amide-type local anesthetics, opioid, or any ingredient of the medications administered in this study. Subject has a resting respiratory rate less than 8 per minute and blood oxygen saturation less than 90 mmHg. Use of any NSAIDs, selective COX-2 inhibitors, opioid, acetaminophen, selective serotonin reuptake inhibitors (SSRI), tricyclic antidepressants (TCA), gabapentin, or pregabalin within three days of surgery. Chronic use of opioid medications for more than 14 days in the last 3 months, or non-opioid pain medications more than 5 times per week before screening visit. Use of any long-acting opioid medication within 3 days of surgery or any opioid medication within 24 hours of surgery. Current painful physical condition or concurrent surgery requires analgesic treatment in the postoperative period. Contraindication to epinephrine or any of the pain-control agents planned for postoperative use. Administration of an investigational drug within the longer of 30 days or 5 elimination half-lives of such investigational drug prior to study drug administration. Any psychiatric disorder, psychological, medical, or laboratory condition that may interfere with study assessments or compliance. Significant medical conditions or laboratory results that may indicate an increased vulnerability to study drugs and procedures, and thus expose the subject to an unreasonable risk as a result of participating in this clinical trial. Any clinically significant event or condition may be uncovered during surgery. History of abuse illicit drugs, prescription medicines or alcohol within the past 2 years. Known history of anti-HIV antibody positive Failure to pass drug and alcohol screen.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SDE 150mg<br>Single dose, intramuscular, Sebacoyl Dinalbuphine Ester injection 150 mg (2 ml) | Drug: Sebacoyl Dinalbuphine Ester<br>* Intramuscular injection 2mL/vial (75mg/mL)<br>* Other names: Nalbuphine Sebacate;|
| Placebo Comparator: placebo<br>Single dose, intramuscular , Sebacoyl Dinalbuphine Ester placebo injection (2mL) | Drug: Placebo<br>* Sebacoyl Dinalbuphine Ester injection placebo, 2mL/vial<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessment calculated as the area under the curve of VAS pain intensity scores through 48 hours after surgery |  | 1±0.1, 2±0.1, 3±0.1, 4±0.25, 8±0.5, 12±0.5, 16±0.5, 20±0.5, 24±1, 28±1, 32±2, 36±2, 40±2, 44±2, 48±2 h after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consumption of ketorolac via intravenous Patient- Controlled Analgesia (IV PCA) |  | Day 1-2 | 
| Pain assessment measured with VAS during Day 3-7 in the morning and evening, as well as during special events such as bowel movements. |  | Day 3-7 | 
| Time from the end of operation to the first PCA Ketorolac dose |  | From the end of operation until the first PCA ketorolac dose used, assessed up to 48 hrs | 
| Brief Pain Inventory (BPI) |  | Day 1, 2 and Day 7 | 
| Consumption of oral Ketorolac (Day 3-7) |  | Day 3-7 | 
| Patient satisfaction-Subject will be asked to classify themselves as either: 'highly satisfied', 'satisfied', 'uncertain', 'dissatisfied' or 'very dissatisfied' |  | Day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Analgesic, Opioids, Pain relief after surgery, Dinalbuphine, Sebacoyl Dinalbuphine Ester, SDE, SDN, LT1001