Acute Pain Study Following Bunionectomy
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Subjects who were in general good health, experiencing moderate to severe pain following bunionectomy
Exclusion criteria
- Subjects who underwent Base wedge osteotomy and / or Long-Z Hart bunionectomy procedures
- Drug allergies to hydrocodone, acetaminophen
- Clinically significant or uncontrolled medical disorders or illness - history of drug or alcohol abuse / addiction
Trial design
Primary purpose
Allocation
Interventional model
Masking
100 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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