Kansas City, Missouri 64108

  • Postoperative Pain

Purpose:

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.


Study summary:

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.


Criteria:

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


Study is Available At:


Original ID:

06 08 128


NCT ID:

NCT00413582


Secondary ID:


Study Acronym:


Brief Title:

Pain Management for Pectus Excavatum Repair


Official Title:

Prospective Randomized Trial: Pain Management Strategy After Pectus Excavatum Repair


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

8 Years


Maximum Age:

18 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Children's Mercy Hospital Kansas City


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

110


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Shawn D St. Peter, MD
Principal Investigator
Children's Mercy Hospital
Primary Contact:Shawn D St. Peter, MD
(816)234-3575 ext. 6465
(816)234-3575
sspeter@cmh.edu
Backup Contact:Susan W Sharp, PhD
(816)234-3575 ext. 6670
(816)234-3575
swsharp@cmh.edu

Study Dates

Start Date:October 2006
Completion Date:November 2009
Completion Type:Anticipated
Primary Completion Date:November 2009
Primary Completion Type:Anticipated
Verification Date:March 2009
Last Changed Date:February 5, 2010
First Received Date:December 18, 2006

Study Outcomes

Outcome Type:Secondary Outcome
Measure: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
Time Frame:1 week
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Length of hospitalization
Time Frame:1 week
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Patient-Controlled IV Analgesia
Description: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 anal
Arm Name:2
Intervention Type:Drug
Name:Epidural Analgesia
Description: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
Arm Name:1

Study Arms

Study Arm Type:Experimental
Arm Name:2
Description:IV narcotic analgesia
Study Arm Type:Active Comparator
Arm Name:1
Description:Epidural analgesia

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Children's Mercy Hospital Kansas City

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: September 23, 2021

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