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Preemptive Analgesia in Children Using Caudal Epidural Ropivacaine

Loma Linda University (LLU) logo

Loma Linda University (LLU)

Status

Terminated

Conditions

Orchiopexy
Inguinal Herniorrhaphy

Treatments

Drug: Ropivacaine

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

26 patients

Sex

All

Ages

Under 2 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Double Blind

26 participants in 3 patient groups

Group CB
Experimental group
Description:
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.
Treatment:
Drug: Ropivacaine
Drug: Ropivacaine
Drug: Ropivacaine
Group CA
Active Comparator group
Description:
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.
Treatment:
Drug: Ropivacaine
Drug: Ropivacaine
Drug: Ropivacaine
Group LIA
Active Comparator group
Description:
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.
Treatment:
Drug: Ropivacaine
Drug: Ropivacaine
Drug: Ropivacaine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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