Pain Management for Pectus Excavatum Repair
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|ClinicalTrials.gov Identifier: NCT00413582|
Recruitment Status : Completed
First Posted : December 20, 2006
Results First Posted : January 16, 2012
Last Update Posted : January 16, 2012
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 or disease||Intervention/treatment||Phase|
|Postoperative Pain||Drug: Epidural Analgesia Drug: Patient-Controlled IV Analgesia||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Randomized Trial: Pain Management Strategy After Pectus Excavatum Repair|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||October 2010|
Active Comparator: 1
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.
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.
- Length of Hospitalization [ Time Frame: 1 week ]
- Time in the Operating Room [ Time Frame: 1 week ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00413582
|United States, Missouri|
|Children's Mercy Hospital|
|Kansas City, Missouri, United States, 64108|
|Principal Investigator:||Shawn D St. Peter, MD||Children's Mercy Hospital|