Post Operative Pain Control Using Ropivacaine and the ON-Q System in the Adult Pectus Excavatum Patient
Condition: Pectus Excavatum
MeSH terms: Funnel Chest; Pain, Postoperative
Study type: Interventional

Summary: 
      Pectus excavatum (PE) is a common chest wall deformity where the sternum is displaced
      posteriorly. In severe cases, surgery is performed to correct the defect. In recent years,
      minimally invasive surgery with the placement of stainless steel support bars has been
      increasingly performed in patients over the age of 17 years. Because of the decreased
      malleability and tremendous pressure required to hold the chest wall in the corrected
      position, post-operative pain control has been a significant problem in this patient
      population. Thoracic epidurals are commonly employed however mean hospitalizations of up to 7
      days have been required before adequate pain control on oral analgesics is obtained and
      patients are suitable for discharge.

      It is hypothesized that using the ON-Q system (I-Flow Corporation, Lake Forest CA) with
      bilateral intercostal catheter infusion would provide adequate post operative pain control
      with a significantly shorter hospital length-of-stay than thoracic epidural. Total use of
      narcotics for 1 week following surgery would also be less with the ON-Q system versus
      epidural.
    

Detailed description: 
      Subjects meeting eligibility criteria were randomized to one of two arms for postoperative
      pain control: the On-Q system versus epidural. All subjects had additional pain management as
      per standardized protocol including subject controlled intravenous analgesia with morphine
      equivalent narcotics for a maximum of 48 hours at which time the subject was transitioned to
      oral pain medications. Subjects using less than 5 mg of Morphine in the first 24 hours after
      surgery were transitioned to oral pain medications at 24 hours. After transition to oral
      analgesia, subjects with continued pain assessment greater than 5 were administered
      intravenous morphine equivalents by nursing staff until pain assessments were less than 5.

      ON-Q catheters could have been maintained for up to 6 days. Discharge of subjects with
      catheters in place was planned. The catheter was removed in the out-patient clinic if the
      subject was discharged before the 6th day. Subjects with epidural had their epidural
      discontinued at 72 hours.

      Data was recorded for each subject by site personnel while the subjects remained
      hospitalized, but were recorded in a journal by subjects after discharge up to postoperative
      day 7.
    

Intervention name(s): ON-Q soaker catheter system; Epidural (ropivicaine 0.25%)
Intervention type(s): Device; Drug
Intervention description(s): ON-Q soaker catheter system with Ropivicaine at 7 cc per hour placed by a single surgeon in the operating room. 7.5" catheters will be tunneled subcutaneously in the anterior axilla bilateral and secured with steri-strips and dressing. ON-Q systems will be primed with 750 cc and refilled accordingly to provide for 6 days of analgesia. Catheters will be removed by the surgeon in the hospital or clinic on the 6th post operative day. Patients may request removal of the catheter prior to the 6th day and this will not be considered a withdrawal from the study or complication and will be included in overall analysis, but noted accordingly.; Thoracic epidural with Ropivicaine 0.25% placed pre-operatively by the anesthesiologist. Epidurals will remain in place for 72 hours and discontinued by the anesthesia pain management team.
Other intervention name(s): Naropin
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment