Hemorrhoids
Conditions
Keywords
hemorrhoids
Brief summary
Effective postoperative pain control to promote improved healing, faster patient mobilization, shortened hospital stays, and reduced healthcare costs.
Detailed description
Effective postoperative pain control is a critical element in patient recovery, as the majority of patients may experience significant pain, particularly in the first few days following surgery. Appropriate postoperative pain management contributes to improved healing, faster patient mobilization, shortened hospital stays, and reduced healthcare costs.
Interventions
DRUGBupivacaine HCl
100 mg Bupivacaine HCl
DRUGSKY0402
Single administration 300 mg SKY0402 in a 40-mL injection volume
Sponsors
Pacira Pharmaceuticals, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female equal or greater than 18 years of age at Screening * Female subjects: postmenopausal, surgically sterile, or willing to use acceptable means of contraception for at least 30 days after surgery, nonheterosexual lifestyle, or strictly monogamous relationship with a partner who has had a vasectomy. * Scheduled to undergo 2-or3-column excisional hemorrhoidectomy * American Society of Anesthesiology (ASA) Physical Class 1-4 * Able and willing to complete with all study visits and procedures * Able to speak, read, and understand the language of all study forms and instruments used for collecting subject-reported outcomes to provide accurate study assessments * Willing and capable of provide written informed consent.
Exclusion criteria
* Pregnant, nursing or planning to become pregnant during the study period * Use of any long-acting opioid medication within 3 days of surgery or any opioid medication with 24 hours of surgery. * Concurrent painful physical condition or concurrent surgery that may require analgesic treatment in the postoperative period for pain not strictly related to the procedure or that may interfere with study assessments. * Single-column hemorrhoidectomy * Body weight less than 50 kg (110 pounds) * History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics, opioid medication, or any ingredient of the medications administered in this study (e.g., sulfites in Marcaine with epinephrine) * contraindication to epinephrine * contraindication to any of the pain-control agents planned for postoperative use * Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug prior to study drug administration * History of, known addiction, or abuse of illicit drugs, prescription medicines or alcohol within the past 2 years. * Uncontrolled anxiety schizophrenic, or other psychiatric disorder that may interfere with study assessments or compliance. * Significant medical conditions or laboratory results that indicate an increased vulnerability to study drugs and procedures, and expose the subject to an unreasonable risk as a result of participating in this clinical trial. * Any clinically significant event or condition uncovered during surgery * A cumulative incision length less than 3 cm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores | through 96 hours | To assess pain intensity at rest (NRS-R), the subject was to assume a resting position that did not exacerbate his or her postoperative pain. The subject was to rest in this position for at least 5 minutes before responding to the following question, On a scale of 0 to 10, where 0=no pain and 10=worst possible pain, how much pain are you having right now? |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events (AEs) Through Day 3 and Serious Adverse Events (SAEs) Through Day 30 | through day 30 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bupivacaine HCl 100 mg Bupivacaine HCl (e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402. | 103 |
| SKY0402 Single administration 300 mg SKY0402 in a 40-mL injection volume via local infiltration. | 101 |
| Total | 204 |
Baseline characteristics
| Characteristic | SKY0402 | Bupivacaine HCl | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 9 Participants | 15 Participants |
| Age, Categorical Between 18 and 65 years | 95 Participants | 94 Participants | 189 Participants |
| Age Continuous | 50.2 years STANDARD_DEVIATION 11 | 49 years STANDARD_DEVIATION 11.6 | 49.6 years STANDARD_DEVIATION 11.3 |
| Region of Enrollment United States | 101 participants | 103 participants | 204 participants |
| Sex: Female, Male Female | 48 Participants | 50 Participants | 98 Participants |
| Sex: Female, Male Male | 53 Participants | 53 Participants | 106 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 65 / 103 | 67 / 101 |
| serious Total, serious adverse events | 1 / 103 | 1 / 101 |
Outcome results
Primary
Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores
To assess pain intensity at rest (NRS-R), the subject was to assume a resting position that did not exacerbate his or her postoperative pain. The subject was to rest in this position for at least 5 minutes before responding to the following question, On a scale of 0 to 10, where 0=no pain and 10=worst possible pain, how much pain are you having right now?
Time frame: through 96 hours
Population: Note: 204 randomized subjects received study drug and were included in the analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupivacaine HCl | Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores | 359 Units on a scale*hours | Standard Deviation 194 |
| SKY0402 | Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores | 396 Units on a scale*hours | Standard Deviation 213 |
Secondary
Number of Participants With Adverse Events (AEs) Through Day 3 and Serious Adverse Events (SAEs) Through Day 30
Time frame: through day 30