This is 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.
This study was a multicenter, double-blind, randomized, placebo-controlled, parallel, pretreatment study, sponsored by Lumosa therapeutics Co., Ltd (Taiwan). All subjects received training of visual analog scores (VAS) before surgery using the 10-mm horizontal version. VAS was taken by study subjects themselves before the first dose of PCA ketorolac, and at 1, 2, 3, 4, 8, 12, 16, 24, 28, 32, 36, 40, 44, 48 hours after surgery. After discharge, VAS was taken, also by the study subjects, twice a day, in the morning and evening of Dayday 3 through Dayday 7. Subjects were asked to complete a short form questionnaire, Brief Pain Inventory, on day 1, day 2, and final visit (day 7-10) after surgery. Patient satisfaction of postsurgical analgesia was assessed at the final visit using a 5-grade categorical scale. The primary objective of the study was to evaluate the efficacy and safety of single intramuscular injection of SDE in an extended-release formulation, against placebo control, administrated pre-operatively in subjects scheduled to undergo elective hemorrhoidectomies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
221
Intramuscular injection 2mL/vial (75mg/mL)
Sebacoyl Dinalbuphine Ester injection placebo, 2mL/vial
Chang Gung Memorial Hospital at Chiayi
Chiayi City, Chiayi Hsien, Taiwan
Chang Gung Memorial Hospital at Linkou
Linkou District, New Taipei City, Taiwan
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung City, Taiwan
Chang Gung Memorial Hospital at Keelung
Keelung, Taiwan
Pain Assessment Calculated as the Area Under the Curve of VAS Pain Intensity Scores Through 48 Hours After Surgery
The primary outcome measure of this study is pain assessment (time-specific pain intensity) calculated as the area under the curve (AUC) of VAS pain intensity scores through 48 hours after surgery (AUC0-48). Pain intensity was measured with visual analog scale (VAS) and the assessment began right before the first use of analgesics, and at 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 hours after the operation.
Time frame: 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
Consumption of Ketorolac Via Intravenous Patient- Controlled Analgesia (IV PCA)
Consumption of ketorolac via intravenous Patient- Controlled Analgesia (IV PCA) was calculated through 48 hrs after surgery (study day1-2)
Time frame: 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.
Pain intensity was assessed using a Visual Analog Scale (VAS). The scale ranged from 0 (no pain) to 10 (worst pain imaginable), reported as units on a scale. Higher values indicate worse pain. Pain intensity were measured with VAS scores in the morning and evening during Day 3-7. It should be noted that the VAS scores during Day 3-7 were not adjusted by rescue medications used for pain relief.
Time frame: Day 3-7
Time From the End of Operation to the First PCA Ketorolac Dose
Time frame: From the end of operation until the first PCA ketorolac dose used, assessed up to 48 hrs
Brief Pain Inventory (BPI)
Pain severity was assessed using the Brief Pain Inventory (BPI). The BPI pain severity score is based on a numeric rating scale ranging from 0 to 10 units on a scale, where 0 indicates no pain and 10 indicates pain as bad as you can imagine. Higher scores represent worse pain outcomes. Assessments were conducted on Day 1, Day 2, and Day 7.
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Cheng Ching General Hospital
Taichung, Taiwan
Tri-Service General Hospital
Taipei, Taiwan
Time frame: Day 1, 2 and Day 7
Consumption of Oral Ketorolac (Day 3-7)
Patients discharged on Day 2. The total amount of oral Ketorolac, as supplemental analgesics after discharge, was used to evaluate the efficacy of extended-release SDE compared with the placebo group.
Time frame: Day 3-7
Subject Satisfaction With Post-Surgical Analgesic Between Treatment Groups
Subject will be asked to classify themselves as either: 'highly satisfied', 'satisfied', 'uncertain', 'dissatisfied' or 'very dissatisfied' at final visit, and a Cochran-Mantel-Haenszel test was used in comparison of subjects' satisfaction with post-surgical analgesic between treatment groups.
Time frame: Day 7