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Analgesia in Children Using Caudal Epidural Ropivacaine

NCT ID: NCT01494272

Last Updated: 2015-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2015-05-31

Brief Summary

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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

Detailed Description

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Conditions

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Inguinal Hernia Circumcision

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group CB (Caudal Before-study group)

This group will receive caudal ropivacaine and epinephrine after induction of general anesthesia prior to surgical incision

No interventions assigned to this group

Caudal After (CA)-control group

This group will receive caudal ropivacaine with epinephrine after completion of surgery but before emergence from anesthesia

No interventions assigned to this group

Local Infiltration After (LIA) control group

This group will receive local infiltration of ropivacaine around the surgery site at the conclusion of surgery but before emergence from anesthesia

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Age 2 months to 2 years
2. Weight 25kg or less
3. ASA class 1, 2, 3
4. Elective inguinal herniorrhaphy or orchiopexy

Exclusion Criteria

1. Contraindications to caudal epidural analgesia
2. parent's refusal
3. skeletal or spinal cord anomaly
4. coagulopathy
5. infection at the insertion site
6. ongoing bacteremia
7. allergy to ropivacaine
Minimum Eligible Age

2 Months

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Loma Linda University

OTHER

Sponsor Role lead

Responsible Party

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Shannon Mulder, MD

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shannon Mulder, MD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University Medical Center

Locations

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Loma Linda University Medical Center

Loma Linda, California, United States

Site Status

Loma Linda University Outpatient Surgery Center

Loma Linda, California, United States

Site Status

Countries

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United States

Other Identifiers

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5110235

Identifier Type: -

Identifier Source: org_study_id