Hemorrhoid
Conditions
Keywords
Hemorrhoid, Hemorrhoidectomy, Postoperative pain, Analgesia
Brief summary
Patients will get an injection of either SKY0402 or placebo during hemorrhoid surgery, and their pain and pain medicine use will be monitored.
Interventions
DRUGSKY0402
During the operation, 30cc of SKY0402 are injected into the wound.
DRUGPlacebo
During the hemorrhoidectomy, 30cc Placebo injected into the wound.
Sponsors
Pacira Pharmaceuticals, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years of age at the Screening visit * American Society of Anesthesiologists (ASA) class 1-3 * Scheduled to have a two or three column excisional hemorrhoidectomy under general anesthesia using the Milligan-Morgan technique * For female subjects, surgically sterile or at least two years menopausal, or using an acceptable method of birth control; must have a documented negative blood or urine pregnancy test within 24 hours before surgery * Clinical lab values less than or equal to twice the upper limit of normal or, if abnormal, deemed not clinically significant per the Investigator. * Ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments * Able to speak, read, and understand the language of all subject-facing documents, including the ICF and study questionnaires * Able and willing to comply with all study visits and procedures
Exclusion criteria
* Single-column hemorrhoidectomy or hemorrhoidectomy without an internal component * Body weight less than 50 kilograms (110 pounds) * History of hypersensitivity or idiosyncratic reactions or amide-type local anesthetics, opioids, or propofol * Current painful physical condition or concurrent surgery other than hemorrhoids that may require analgesic treatment (such as non-steroidal anti-inflammatory drug \[NSAID\], opioid, selective serotonin reuptake inhibitor \[SSRI\], tricyclic antidepressant, gabapentin, pregabalin) in the postoperative period for pain that is not strictly related to the hemorrhoidectomy procedure and may confound the postoperative assessments * Concurrent fissurectomy * Use of any NSAID including selective COX-2 inhibitor, opioid, SSRI, tricyclic antidepressant, gabapentin, or pregabalin within three days of surgery * Use of acetaminophen within 24 hours of surgery * Chronic users of analgesic medications, including taking opioid medications for more than 14 days in the last 3 months, or non-opioid pain medications more than 5 times per week * History of, suspected, or known addiction to or abuse of drugs or alcohol within the past two years * Current use of glucocorticosteroids or use of glucocorticoids within one month of enrollment into this study * HIV infection or hepatitis * Currently pregnant, nursing, or planning to become pregnant during the course of the study or within one month of study drug administration * Any psychiatric, psychological, medical, or laboratory condition that the investigator feels makes the subject an inappropriate candidate for this clinical trial * Subjects who have received another investigational drug within the longer of the last 30 days or 10 elimination half-lives * Previous participation in a SKY0402 study * Failure to pass drug and alcohol screen
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores Through 72 Hours for Subjects Receiving SKY0402 vs. Placebo. | 72 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 and respond 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 |
|---|---|
| Participants With Adverse Events Through 72 Hours or Serious Adverse Events Through 30 Days | 30 days |
Countries
Poland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SKY0402 During the hemorrhoidectomy, 30cc of SKY0402 is injected into the wound. | 95 |
| Placebo During the hemorrhoidectomy, 30cc Placebo injected into the wound. | 94 |
| Total | 189 |
Baseline characteristics
| Characteristic | SKY0402 | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 8 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 86 Participants | 86 Participants | 172 Participants |
| Age Continuous | 48 years STANDARD_DEVIATION 12.2 | 48.7 years STANDARD_DEVIATION 12 | 48.4 years STANDARD_DEVIATION 12 |
| Region of Enrollment Georgia | 34 participants | 33 participants | 67 participants |
| Region of Enrollment Poland | 36 participants | 36 participants | 72 participants |
| Region of Enrollment Serbia | 25 participants | 25 participants | 50 participants |
| Sex: Female, Male Female | 32 Participants | 27 Participants | 59 Participants |
| Sex: Female, Male Male | 63 Participants | 67 Participants | 130 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 94 | 5 / 93 |
| serious Total, serious adverse events | 0 / 94 | 1 / 93 |
Outcome results
Primary
The Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores Through 72 Hours for Subjects Receiving SKY0402 vs. Placebo.
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 and respond 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: 72 hours
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| SKY0402 | The Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores Through 72 Hours for Subjects Receiving SKY0402 vs. Placebo. | 141.8 units on a scale*hr | Standard Error 10.7 |
| Placebo | The Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores Through 72 Hours for Subjects Receiving SKY0402 vs. Placebo. | 202.5 units on a scale*hr | Standard Error 10.7 |
Secondary
Participants With Adverse Events Through 72 Hours or Serious Adverse Events Through 30 Days
Time frame: 30 days