Pain Management for Pectus Excavatum Repair
Condition: Postoperative Pain
MeSH terms: Funnel Chest
Study type: Interventional

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.
    

Intervention name(s): Epidural Analgesia; Patient-Controlled IV Analgesia
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pectus Excavatum; Bar Repair; Pain Control; Pectus Excavatum Repair