The purpose of this study is to assess the effectiveness, safety and pharmacokinetics of Oral Nalbuphine in the treatment of postoperative pain following hemorrhoidectomy.
• Primary Efficacy Endpoint: Pain assessment calculated as the area under the curve of VAS pain intensity scores through 48 hours. • Secondary Efficacy Endpoints: 1. Consumption of diclofenac (Day 1-2) via Intramuscular Injection (IM injection). 2. Time from the end of operation to the first IM injection diclofenac dose 3. Brief Pain Inventory (BPI). 4. Patient satisfaction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
106
Multiple dose of oral PHN131 soft capsule with Nalbuphine HCl 60 mg/cap, initial dose : 120 mg ( 2 capsules), then 60 mg (1 capsule); t.i.d.
Multiple dose of oral Placebo soft capsules, initial dose: 2 capsules, then 1 capsule; t.i.d.
All subjects will receive diclofenac by IM injection for analgesia as rescue pain control.
General Clinical Research Center, Tri-service General Hospital
Taipei, Taiwan
the area under the curve of VAS pain intensity scores
Pain assessment calculated as the area under the curve of VAS pain intensity scores through 48 hours
Time frame: at 1, 2, 3, 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, and 48±2 h after the surgery
Consumption of diclofenac dose
Consumption of diclofenac (Day 1-2) via Intramuscular Injection (IM injection)
Time frame: in 48 hours after surgery
Time of operation to diclofenac dose
Time from the end of operation to the first IM injection diclofenac dose
Time frame: in 48 hours after surgery
Brief Pain Inventory (BPI)
Brief Pain Inventory (BPI)
Time frame: at 24h and 48h after surgery
Patient satisfaction
Patient satisfaction
Time frame: at 48h after surgery
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