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Very Low Dose Caudal Morphine for Postoperative Pain Management

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by University of Oklahoma.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00938821
First received: July 9, 2009
Last updated: February 1, 2012
Last verified: February 2012
  Purpose

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 Intervention
Caudal Anesthesia
Procedure: Caudal block

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: The Use of Very Low Dose Caudal Morphine for Postoperative Pain Management in Out Patients

Resource links provided by NLM:


Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • The study's primary research question, which relates to between-group differences is duration of analgesia. [ Time Frame: 1 year 5 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Between-group differences in the proportion of patients clinically significant side effects will be assessed. [ Time Frame: 1 year 5 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: January 2010
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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:
  • Caudal Block
  • Postoperative pain
  • Morphine
  • Bupivacaine

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.

  Eligibility

Ages Eligible for Study:   1 Month to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

This is a chart review from October 2008 to October 2009 of children from 1 month of age to 10 years old that went to 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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00938821

Locations
United States, Oklahoma
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
  More Information

Publications:

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00938821     History of Changes
Other Study ID Numbers: 15028
Study First Received: July 9, 2009
Last Updated: February 1, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Morphine
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014