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PI is no longer here.
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Caudal epidural analgesia (caudal block) is used in standard pediatric anesthesia practice. It has been shown to be effective in managing postoperative pain in children undergoing abdominal and infraumbilical surgery (Tobias et al 1994). Furthermore, studies have shown that children receiving caudal blocks have secondary benefits such as lower narcotic and anesthetic requirements, more rapid awakening from general anesthesia, decreased time to discharge home, and fewer pain-related behaviors postoperatively (Conroy et al 1993, Tobias et al 1995, Tobias 1996).
This proposed study involves the use of a caudal block in children undergoing elective inguinal herniorrhaphy or orchiopexy to evaluate the role of preemptive analgesia in pediatric pain management. We hypothesize that by inhibiting peripheral pain receptors with a caudal block before the onset of a painful stimulus, we can decrease central nervous system sensitization and reduce postoperative analgesic requirements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group CB | Experimental | Subjects in this arm will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after induction of general anesthesia prior to surgical incision. |
|
| Group CA | Active Comparator | Group CA (Caudal After-control group) will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after completion of surgery but before emergence from anesthesia. |
|
| Group LIA | Active Comparator | Group LIA (Local Infiltration After-control group) will receive local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site at the conclusion of surgery but before emergence from anesthesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug | caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Usage of Pain Medications | Over 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Lee, M.D. | Loma Linda University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University Medical Center | Loma Linda | California | 92354 | United States |
IRB annual renewal indicates 26 participants Resident on the project indicates only 22 started the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group CB | Subjects in this arm will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after induction of general anesthesia prior to surgical incision. Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine |
| FG001 | Group CA | Group CA (Caudal After-control group) will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after completion of surgery but before emergence from anesthesia. Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine |
| FG002 | Group LIA | Group LIA (Local Infiltration After-control group) will receive local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site at the conclusion of surgery but before emergence from anesthesia. Ropivacaine: local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
PI left institution and records cannot be located
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| ID | Title | Description |
|---|---|---|
| BG000 | Group CB | Subjects in this arm will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after induction of general anesthesia prior to surgical incision. Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Usage of Pain Medications | PI left institution and records cannot be located. | Posted | Over 24 hours |
|
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Cannot verify AE occurrence. PI has left the institution and records cannot be located.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group CB | Subjects in this arm will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after induction of general anesthesia prior to surgical incision. Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charles Lee, MD | Loma Linda University | 909-558-9408 | thamilton@llu.edu |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Ropivacaine | Drug | caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine |
|
| Ropivacaine | Drug | local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site |
|
| Group CA |
Group CA (Caudal After-control group) will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after completion of surgery but before emergence from anesthesia. Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine |
| BG002 | Group LIA | Group LIA (Local Infiltration After-control group) will receive local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site at the conclusion of surgery but before emergence from anesthesia. Ropivacaine: local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site |
| BG003 | Total | Total of all reporting groups |
|
| Sex: Female, Male |
|
| Region of Enrollment | participants |
|
| OG002 | Group LIA | Group LIA (Local Infiltration After-control group) will receive local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site at the conclusion of surgery but before emergence from anesthesia. Ropivacaine: local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site |
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Group CA | Group CA (Caudal After-control group) will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after completion of surgery but before emergence from anesthesia. Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine | 0 | 0 | 0 | 0 |
| EG002 | Group LIA | Group LIA (Local Infiltration After-control group) will receive local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site at the conclusion of surgery but before emergence from anesthesia. Ropivacaine: local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site | 0 | 0 | 0 | 0 |
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| D000588 |
| Amines |