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This study will investigate the effect of three types of wound infiltration on post Cesarean opioid analgesia consumption when used in conjunction with an opioid free postoperative analgesia pathway.
The subjects that meet the inclusion criteria of the study will be randomized preoperatively into three arms following a 1:1:1 ratio. During the intraoperative course one of three combinations of wound infiltration will be administered to subjects prior to the closure of the surgical incision. Subjects in Group I will receive a placebo of normal saline. Subjects in Group II will receive bupivacaine alone. Subjects in Group III will receive both bupivacaine and dexmedetomidine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Wound infiltration with a placebo |
|
| Bupivacaine | Experimental | Wound Infiltration with 20 mL (150mg) of 0.75% bupivacaine diluted with 5 mL of normal saline to give a 25 mL |
|
| Bupivacaine and Dexmedetomidine | Experimental | Wound Infiltration with 20 mL (150mg) of 0.75% bupivacaine and 1.5 mcg/kg of dexmedetomidine will be diluted with normal saline to make 25 mL of solution . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | Injection of bupivacaine into the surgical incision prior to its closure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total number of opioid free Cesarean deliveries | Measure the number of Cesarean deliveries that did not require opioid analgesia during the postoperative course | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first rescue analgesia | Measure the time to first rescue analgesia from immediate post operative (0 hour) till when the rescue analgesia is administered | 0 hour post-cesarean to time rescue analgeisa is administered] |
| Total opioid consumption |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nisha Lakhi, MD | Contact | 718-818-2109 | NLAKHI@RUMCSI.org |
| Name | Affiliation | Role |
|---|---|---|
| Nisha Lakhi, MD | Richmond University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Richmond University Medical Center | Staten Island | New York | 10310 | United States |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Dexmedetomidine | Drug | Injection of dexmedetomidine ( an adjuvant) into the surgical incision prior to its closure. |
|
|
| Placebo | Drug | Injection of a placebo into the surgical wound |
|
Measure the subjects total opioid consumption for the total duration of the postoperative course.
| 0-14 days |
| Side effects/Adverse reactions | Measure any side effects/allergic reactions attributed to use of any of the study drugs. | 0-14 days |
| Postoperative hospital stay | Measure the length of the post-operative hospital stay . | 0-14days |
| Complications from procedures | Measure any complications associated with the wound infiltration procedure | 0-14 days |
| Breast feeding capacity | Assess the subject's capacity to breast feed during the postoperative course | 0-14 days |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D000588 |
| Amines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |