The primary purpose of this study was to evaluate analgesic efficacy and safety of hydrocodone/acetaminophen extended release compared to placebo in the treatment of moderate to severe pain following bunionectomy.
The bunionectomy was performed under regional anesthesia and propofol sedation. Perioperative anesthesia was standardized for all participants. Upon completion of surgery, designated study personnel ensured continued eligibility per the selection criteria of the protocol. After an appropriate period of time following bunionectomy, participants who had a pain intensity score of ≥ 40 mm on a 100 mm visual analog scale (VAS) and moderate or severe pain intensity per the categorical pain intensity scale were eligible for randomization, in equal numbers, into 1 of 2 treatment arms: hydrocodone/acetaminophen extended release or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
Placebo tablet
Site Reference ID/Investigator# 51464
Pasadena, California, United States
Site Reference ID/Investigator# 51602
Austin, Texas, United States
Site Reference ID/Investigator# 51344
Salt Lake City, Utah, United States
Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS)
Participants assessed pain intensity on a 100 mm visual analogue scale (VAS) with 0 meaning "no pain" and 100 meaning the "worst pain imaginable". The SPID VAS score for 0 to 12 hours following initial study drug dose measured the cumulative pain intensity difference during treatment with higher mean SPID VAS scores indicating greater improvement from Baseline. The SPID score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule.
Time frame: From time of first study drug administration to 12 hours following first study drug administration
TOTPAR (Total Pain Relief)
TOTPAR was the time-interval weighted sum of pain relief. Pain relief was assessed by participants' responses to how their pain relief was compared with the pain they had just before receiving the first dose of study drug: no relief, a little relief, some relief, a lot of relief, or complete relief. Higher mean TOTPAR scores indicate better pain relief. The TOTPAR score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule.
Time frame: From time of first study drug administration to 12 hours following first study drug administration
SPRID (Pain Relief and Pain Intensity Difference)
SPRID was defined as the sum of Pain Relief score (TOTPAR, See Outcome Measure 2 for details\*) plus the Pain Intensity Difference (SPID) Categorical score, where participants assessed pain intensity on a Categorical Pain Intensity Scale by answering the following question: "My pain at this time is…" with one of the following responses: no pain or none, mild pain, moderate pain, or severe pain). Higher mean SPRID scores indicated better pain control. The SPRID score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule.
Time frame: From time of first study drug administration to 12 hours following first study drug administration
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Time to Perceptible and Meaningful Pain Relief
The median time (minutes) from first perceptible pain relief (onset of pain relief) and time until first meaningful pain relief.
Time frame: From time of first study drug administration to 12 hours following first study drug administration