An interventional study of Ropivacaine and Ropivacaine in Inguinal Herniorrhaphy and Orchiopexy, sponsored by Loma Linda University. Terminated at 1 site in United States. Open to participants aged Up to 2 Years. Per ClinicalTrials.gov, last updated 2019-04-25.
Sponsored by Loma Linda University · Not applicable, Interventional, and Treatment
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.
Loma Linda University is the lead sponsor of 305 studies on the registry; 48 are open to participants now.
Of its 29 completed or terminated interventional studies of FDA-regulated products, 23 (79%) have results posted.
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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.
Drug: Ropivacaine
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.
Drug: Ropivacaine
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.
Drug: Ropivacaine
caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine
caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine
local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site
Usage of Pain Medications
Time frame: Over 24 hours
| Milestone | Group CB | Group CA | Group LIA |
|---|---|---|---|
| Started | 6 | 9 | 7 |
| Completed | 6 | 9 | 7 |
| Not completed | 0 | 0 | 0 |
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group CB | — | — | — |
| Group CA | — | — | — |
| Group LIA | — | — | — |
PI left institution and records cannot be located
| Age, Categorical | Group CB | Group CA | Group LIA | Total |
|---|---|---|---|---|
| <=18 years | — | — | — | — |
| Between 18 and 65 years | — | — | — | — |
| >=65 years | — | — | — | — |
| Sex: Female, Male | Group CB | Group CA | Group LIA | Total |
|---|---|---|---|---|
| Female | — | — | — | — |
| Male | — | — | — | — |
| Region of Enrollment(participants) | Group CB | Group CA | Group LIA | Total |
|---|
The record gives a start of Oct 2007, a primary completion of Sep 2010 and a completion of Sep 2010. It does not say whether these dates are actual or estimated.
Results were first posted in Apr 2015, 4 years 7 months after primary completion.
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This study is terminated, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ropivacaine