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Subjects receive either CPL-01, positive control, or negative control after herniorrhaphy and are then followed.
Subjects pain and rescue medication use is assessed after having received either CPL-01, placebo, or ropivacaine HCl for several days after hernia repair surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPL-01 | Experimental | Local infiltration of CPL-01 |
|
| Ropivacaine HCl | Active Comparator | Local infiltration of Naropin |
|
| Placebo | Placebo Comparator | Local infiltration of Saline Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| local anaesthetic injection of CPL-01 | Drug | Local infiltration of study drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain control | Area under the curve of the numeric rating score for pain with activity, where 0 is no pain and 10 is worst pain imaginable | 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erol Onel | Cali Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Todd Bertoch | Salt Lake City | Utah | 84101 | United States |
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| Morphine (rescue medication) | Drug | Opioid rescue allowed by IV if requested |
|
|
| Acetaminophen (rescue medication) | Drug | Acetaminophen rescue allowed if requested |
|
|
| Oxycodone (rescue medication) | Drug | Opioid rescue allowed by mouth if requested |
|
|
| local anaesthetic injection of placebo | Drug | Local infiltration of study drug |
|
|
| local anaesthetic injection of ropivacaine HCl | Drug | Local infiltration of study drug |
|
|
| Open inguinal hernia repair | Procedure | Surgical hernia repair |
|
|
| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| D000701 | Analgesics, Opioid |
| D000082 | Acetaminophen |
| D010098 | Oxycodone |
| D000077330 | Saline Solution |
| D000077212 | Ropivacaine |
| D059685 | Herniorrhaphy |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D009294 | Narcotics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D003061 | Codeine |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D019651 | Plastic Surgery Procedures |
| D013514 | Surgical Procedures, Operative |
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