Very Low Dose Caudal Morphine for Postoperative Pain Management

Sponsor
University of Oklahoma (Other)
Overall Status
Completed
CT.gov ID
NCT00938821
Collaborator
(none)
33
1
35.3
0.9

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Procedure: Caudal block

Detailed 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.

Study Design

Study Type:
Observational
Actual Enrollment :
33 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
The Use of Very Low Dose Caudal Morphine for Postoperative Pain Management in Out Patients
Study Start Date :
Jan 1, 2010
Actual Primary Completion Date :
Dec 11, 2012
Actual Study Completion Date :
Dec 11, 2012

Arms and Interventions

Arm Intervention/Treatment
Caudal Block

Review of charts of patients that received very low dose morphine administered caudally (M) and plain caudal block with Ropivacaine or Marcaine (B).

Procedure: 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.
Other Names:
  • Postoperative pain
  • Morphine
  • Bupivacaine
  • Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Month to 10 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The University of Oklahoma Health Sciences Center Deparment of Anesthesiology Oklahoma City Oklahoma United States 73104

    Sponsors and Collaborators

    • University of Oklahoma

    Investigators

    • Principal Investigator: Alberto J. de Armendi, MD, AM, MBA, Oklahoma University Health Sciences Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of Oklahoma
    ClinicalTrials.gov Identifier:
    NCT00938821
    Other Study ID Numbers:
    • 15028
    First Posted:
    Jul 14, 2009
    Last Update Posted:
    Nov 21, 2017
    Last Verified:
    Nov 1, 2017
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 21, 2017