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LNP is new extended release (ER) oily solution formulation of ropivacaine that is intended for local infiltration into surgical wounds. The purpose of this study is to determine the ease of usage and administration of LNP in the surgical setting, to follow the Pharmacokinetic (PK) profile of LNP over 72 hours and evaluate the duration of analgesia witnessed in the surgical setting.
LNP is new extended release (ER) oily solution formulation of ropivacaine that is intended for local infiltration into surgical wounds. The formulation is designed to slowly release the ropivacaine over 36-72 hours. By providing local analgesia over a long time span, the need for systemic analgesics is expected to be reduced and hospital stays may be shortened. The purpose of this study is to determine the ease of usage and administration of LNP in the surgical setting, to follow the PK profile of LNP over 72 hours and evaluate the duration of analgesia witnessed in the surgical setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Application of PRF110- oily solution | Experimental | Post operative application of new extended release PRF110- oily solution (Ropivacaine) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRF110- oily solution (Ropivacaine) | Drug | Post operative application of PRF110-oily solution (Ropivacaine) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment emergent adverse events (safety and tolerability). | All adverse events (AE) reported by the subjects will be recorded throughout the trial period | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Pain intensity | Pain on a scale of 0-10 assessed at 0,1,2,4,8,12,24,36,48,60,72hrs post operation will be used to evaluate pain intensity | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Use of rescue medication | Overall use of rescue medication post operation | 72 hours |
| Maximum plasma concentration (Cmax) | Samples will be collected at designated times up to 72hrs post drug application |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Moaad Farraj, Dr. | Galilee Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western Galil Medical Center | Nahariya | 2210001 | Israel | |||
| Assaf Harofeh Medical Center |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| 72 hrs |
| Rishon LeZiyyon |
| Israel |
| Sourasky Medical Center | Tel Aviv | Israel |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |