Preemptive Analgesia in Children Using Caudal Epidural Ropivacaine

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2010-09-30

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.

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Detailed Description

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Conditions

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Inguinal Herniorrhaphy Orchiopexy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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.

Group Type EXPERIMENTAL

Ropivacaine

Intervention Type DRUG

caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine

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.

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine

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.

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site

Interventions

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Ropivacaine

caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine

Intervention Type DRUG

Ropivacaine

caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine

Intervention Type DRUG

Ropivacaine

local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 2 years or younger.
* Weight 33 kg or less.
* Scheduled for elective inguinal herniorrhaphy or orchiopexy.
* American Society of Anesthesiologists Class 1, 2 or 3.

Exclusion Criteria

* Age over 2 years.
* Weight over 33 kg.
* Allergy to ropivacaine.
* Usual contraindications to caudal anesthesia (patient refusal, skeletal or spinal cord anomaly, coagulopathy, infection at insertion site, ongoing bacteremia)

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No