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Pain Management for Pectus Excavatum Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00413582
Recruitment Status : Completed
First Posted : December 20, 2006
Results First Posted : January 16, 2012
Last Update Posted : January 16, 2012
Sponsor:
Information provided by (Responsible Party):
Shawn St. Peter, Children's Mercy Hospital Kansas City

Tracking Information
First Submitted Date  ICMJE December 18, 2006
First Posted Date  ICMJE December 20, 2006
Results First Submitted Date  ICMJE December 12, 2011
Results First Posted Date  ICMJE January 16, 2012
Last Update Posted Date January 16, 2012
Study Start Date  ICMJE October 2006
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2007)
Length of Hospitalization [ Time Frame: 1 week ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 19, 2006)
Length of Hospitalization
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2011)
Time in the Operating Room [ Time Frame: 1 week ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2006)
Time in the operating room, time to urinary catheter removal, time to regular diet, time to removal of oxygen support, time to transition to oral pain meds
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pain Management for Pectus Excavatum Repair
Official Title  ICMJE Prospective Randomized Trial: Pain Management Strategy After Pectus Excavatum Repair
Brief Summary

The objective of this study is to scientifically evaluate two different management strategies for post-operative pain after pectus excavatum repair.

The hypothesis is that pain management without an epidural decreases hospital stay without compromising comfort.

The primary outcome variable is length of hospitalization after the intervention.

Detailed Description

This will be a single institution, prospective, randomized clinical trial involving patients who undergo the minimally invasive repair of a pectus excavatum deformity with bar placement. This is intended to be a definitive study.

Power calculations based on the known length of hospitalization listed above with α = 0.05 and power of 0.8 show the need for 55 patients in each arm. The primary end point will be reached during the hospital stay; therefore, we expect a very small amount of attrition and will intend to recruit 110. One group will undergo an attempt for epidural regional analgesia (epidural) for post-operative pain control. The other groups will receive patient controlled intravenous systemic analgesia (PCA).

Both groups will have the same management algorithm. All data will be analyzed on intention-to-treat basis.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Postoperative Pain
Intervention  ICMJE
  • Drug: Epidural Analgesia
    Upon arrival to the operating room, patients will have a thoracic epidural (T 6-9) placed while in the sitting position. All epidural catheters will be inserted 3-5 cm within the epidural space and will be placed by attending anesthesiologists. Patients will receive midazolam 0.025 - 0.05 mg/kg IV (max 5mg) and/or fentanyl 0.5 - 2 mcg/kg IV for comfort during the procedure. Once the epidural is placed, the patient will be positioned for surgery. The epidural catheter will be initially bolused with 0.3ml/kg of ropivacaine 0.10% (max 10 ml), fentanyl 1 - 1.2 mcg/kg and clonidine 1.8 - 2mcg/kg. An infusion of ropivacaine 0.10%, fentanyl 2mcg/ml and clonidine 1.5mcg/ml will be initiated immediately at the rate of 0.3ml/kg/hr (max 10ml/hr). Intraoperatively, patients will receive intravenous fentanyl if indicated.
  • Drug: Patient-Controlled IV Analgesia
    In the PCA arm, patients will receive fentanyl (3-6 mcg/kg) at anesthesia induction. Additional fentanyl may be administered intraoperatively as indicated. Patients who are > 35 Kg. (in keeping with current FDA approved labeling) will receive a clonidine 0.1 mg/day transdermal patch to the deltoid immediately after induction of anesthesia. Subjects in the epidural arm also receive clonidine. Upon arrival to the post anesthesia care unit, patients will be placed on a patient controlled analgesic (PCA) pump (hydromorphone: loading dose if needed; 5-6 mcg/kg continuous infusion; 5-6 mcg/kg six minute demand dose). An additional hydromorphone dose (8mcg/kg) will be available every 2 hours for pain scores of > 4/10 throughout the duration of PCA use.
Study Arms  ICMJE
  • Active Comparator: 1
    Epidural analgesia
    Intervention: Drug: Epidural Analgesia
  • Experimental: 2
    IV narcotic analgesia
    Intervention: Drug: Patient-Controlled IV Analgesia
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 19, 2006)
110
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients undergoing a pectus excavatum repair with bar placement.

Exclusion Criteria:

  • Open repair
  • Re-Do operation
  • Known allergy to a pain medication in the protocol
  • Existing contraindications to epidural catheter placement
  • Requirement for 2 bars to be placed (rare)
  • Inadequate baseline cognitive function to understand/respond to VAS questionnaire
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00413582
Other Study ID Numbers  ICMJE 06 08 128
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shawn St. Peter, Children's Mercy Hospital Kansas City
Study Sponsor  ICMJE Children's Mercy Hospital Kansas City
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shawn D St. Peter, MD Children's Mercy Hospital Kansas City
PRS Account Children's Mercy Hospital Kansas City
Verification Date December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP