This trial is active, not recruiting.

Condition caudal anesthesia
Treatment caudal block
Sponsor University of Oklahoma
Start date January 2010
End date August 2012
Trial size 40 participants
Trial identifier NCT00938821, 15028


This is a chart review. The aim of this study is to investigate the effectiveness and side effects of very low dose morphine administered caudally to children that went to surgical procedures that used caudal anesthesia. The study compares caudal block with Bupivacaine (1 ml kg_1 of bupivacaine 0.25% and saline 0.02 ml kg_10) with very low dose morphine (a mix of 1 ml kg_-1 of ropivacaine 0.2% and preservative-free morphine: 10 µg kg-1).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective retrospective
Review of charts of patients that received very low dose morphine administered caudally (M) and plain caudal block with Ropivacaine or Marcaine (B).
caudal block Caudal Block
Chart review of patients that received very low dose morphine administered caudally (M) and plain caudal block with Ropivacaine or Marcaine (B)from October 2008 to October 2009.

Primary Outcomes

The study's primary research question, which relates to between-group differences is duration of analgesia.
time frame: 1 year 5 months

Secondary Outcomes

Between-group differences in the proportion of patients clinically significant side effects will be assessed.
time frame: 1 year 5 months

Eligibility Criteria

Male or female participants from 1 month up to 10 years old.

Inclusion Criteria: - The subject did have elective Urological procedures such us circumcision, orchidopexy and inguinal hernia repair, orthopedic and general surgery procedures for which caudal block are usually administered for pain management. Exclusion Criteria: - Subjects with non elective or emergency surgery (must have the surgery no matter what). - Subjects with surgical procedures that are not planned to be conducted with the use of general anesthesia. Subjects that are not allowed to receive the anesthesia agents indicated per protocol and general anesthesia. - American Society of Anesthesiologists, Physical Status classification greater than 2 (uncontrolled systemic disease or more than one systemic disease). - Patients with a history of chronic pain conditions. - Infection around the sacral hiatus. - Coagulopathy. - Anatomic abnormalities. - Patient with mentally retardation. - Patient with history of attention deficit and/or behavioral problems.

Additional Information

Official title The Use of Very Low Dose Caudal Morphine for Postoperative Pain Management in Out Patients
Principal investigator Alberto J. de Armendi, MD, AM, MBA
Description Caudal anesthesia is the most common technique of epidural anesthesia in children. Caudal anesthesia is recommended for most surgical procedures of the lower part of the body, including herniorrhaphies; operations on the urinary tract, anus, and rectum; and orthopedic procedures on the pelvic girdle and lower extremities. Many anesthetic agents have been used for caudal anesthesia in pediatric patients, with lidocaine and Bupivacaine being most common. The major problems associated with this technique are the limited duration of analgesia and unwanted motor blockade. Addition of medications that prolong analgesia after a single shot caudal block has been investigated. Several authors have mentioned a special interest in using an opioid like morphine in caudal block for postoperative analgesia. When low dose morphine is used, the side effects are lower than when higher dose of morphine are used. A larger and definitive study is needed to compare very low dose morphine via caudal administration and caudal block without Opioid with regard to duration of analgesia and frequency of side effects. We plan to conduct a chart review in our center on pediatric patients that went to urological, orthopedic, and general surgery procedures for which caudal block were given and compare the effectiveness and side effects of very low dose morphine and caudal block without Opioid.
Trial information was received from ClinicalTrials.gov and was last updated in February 2012.
Information provided to ClinicalTrials.gov by University of Oklahoma.