Clinical Trial: Post Operative Pain Control Using Ropivacaine and the ON-Q System in the Adult Pectus Excavatum Patient

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Prospective, Randomized, Controlled Trial of Post Operative Pain Control Using Ropivacaine and the ON-Q System in the Adult Pectus Excavatum Patient After Minimally Inva

Brief 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 Summary:

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.


Sponsor: Mayo Clinic

Current Primary Outcome:

  • Hospital Length of Stay [ Time Frame: Up to 11 days post operation ]
    Hospital length of stay was measured from the day of surgery (day 0) through postoperative day 11.
  • Use of Analgesic Narcotic [ Time Frame: 1-7 days post operation ]
    Postoperative analgesic used each day over 7 day postoperative period.


Original Primary Outcome:

  • Use of Analgesic Narcotic [ Time Frame: 1-7 days post operation ]
  • Hospital Length of Stay [ Time Frame: Up to 7 day post operation ]


Current Secondary Outcome: Mean Daily Pain Score [ Time Frame: Days 1-7 post operation ]

Pain was measured by a visual analogue scale (VAS) with pre-set markings from 0 to 10, with 0 for no pain to 10 for the worst possible pain. On the case report form each day had 6 time categories: waking up in the morning, around lunch time, afternoon approximately 3-4 pm, dinner time, bedtime, and during the night time. Each day was averaged for each subject, then the values for each arm were averaged.


Original Secondary Outcome:

  • Visual analogue scale (VAS) score [ Time Frame: Days 1-7 post operation ]
  • Patient satisfaction with pain control [ Time Frame: 7 days post operation ]
    The satisfaction is measured by asking patients "Was it worth it?". A yes/no response will be collected from each patient.
  • Readmission to hospital or emergency room for pain control [ Time Frame: Up to 3 months post operation ]
  • Contact with surgical staff for pain related issues after discharge [ Time Frame: Up to 3 months post operation ]


Information By: Mayo Clinic

Dates:
Date Received: February 28, 2013
Date Started: April 2013
Date Completion:
Last Updated: February 15, 2017
Last Verified: February 2017