Pain Management for Pectus Excavatum Repair - Full Text View

Sponsored by:	Children's Mercy Hospital Kansas City
Information provided by:	Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:	NCT00413582

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.

Condition	Intervention
Postoperative Pain	Drug: Epidural Analgesia Drug: Patient-Controlled IV Analgesia

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Prospective Randomized Trial: Pain Management Strategy After Pectus Excavatum Repair

Further study details as provided by Children's Mercy Hospital Kansas City:

Primary Outcome Measures:

Length of hospitalization [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	110
Study Start Date:	October 2006
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Epidural analgesia	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 ropivicaine 0.10% (max 10 ml), fentanyl 1 - 1.2 mcg/kg and clonidine 1.8 - 2mcg/kg. An infusion of ropivicaine 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.
2: Experimental IV narcotic analgesia	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.

Arms

Assigned Interventions

1: Active Comparator

Epidural analgesia

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 ropivicaine 0.10% (max 10 ml), fentanyl 1 - 1.2 mcg/kg and clonidine 1.8 - 2mcg/kg. An infusion of ropivicaine 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.

2: Experimental

IV narcotic analgesia

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.

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.

Eligibility

Ages Eligible for Study:	8 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00413582

Contacts

Contact: Shawn D St. Peter, MD	(816)234-3575 ext 6465	sspeter@cmh.edu
Contact: Susan W Sharp, PhD	(816)234-3575 ext 6670	swsharp@cmh.edu

Locations

United States, Missouri
Children's Mercy Hospital	Recruiting
Kansas City, Missouri, United States, 64108
Contact: Shawn D St. Peter, MD 816-234-3575 ext 6465 sspeter@cmh.edu
Principal Investigator: Shawn D St. Peter, MD
Sub-Investigator: Kathy A Weesner, MD
Sub-Investigator: Susan W Sharp, PhD

Sponsors and Collaborators

Children's Mercy Hospital Kansas City

Investigators

Principal Investigator:

Shawn D St. Peter, MD

Children's Mercy Hospital

More Information

No publications provided

Responsible Party:	Children's Mercy Hospital ( Shawn St. Peter )
Study ID Numbers:	06 08 128
Study First Received:	December 18, 2006
Last Updated:	March 2, 2009
ClinicalTrials.gov Identifier:	NCT00413582 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Children's Mercy Hospital Kansas City:

Pectus Excavatum
Bar Repair
Pain Control
Pectus Excavatum Repair

Study placed in the following topic categories:

Hydromorphone
Fentanyl
Clonidine
Anesthetics
Pain
Midazolam
Bone Diseases
Funnel Chest

Musculoskeletal Abnormalities
Signs and Symptoms
Musculoskeletal Diseases
Postoperative Complications
Bone Diseases, Developmental
Analgesics
Congenital Abnormalities
Pain, Postoperative

Additional relevant MeSH terms:

Signs and Symptoms
Pathologic Processes
Postoperative Complications
Musculoskeletal Diseases
Bone Diseases, Developmental
Pain

Congenital Abnormalities
Bone Diseases
Pain, Postoperative
Musculoskeletal Abnormalities
Funnel Chest

ClinicalTrials.gov processed this record on September 11, 2009