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OpenTrials
Completed

NCT Number: NCT01816477

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Arizona

Phoenix, Arizona, 85054, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who are scheduled for repair of their pectus excavatum with minimally invasive (MIRPE) placement of steel or titanium braces at Mayo Clinic Arizona
  • Must be able to take oral medications preoperatively and postoperatively.

Exclusion criteria

  • American Society of Anesthesiology class IV or higher
  • Allergic to Ropivacaine or other local anesthetics
  • NSAID allergy
  • Specific epidural contraindication
  • Currently using opioids, sedatives, or hypnotics
  • Are pregnant as verified by preoperative pregnancy testing
  • Inability to place an epidural, patient refusal for epidural, or failure of an epidural to be properly placed or maintain proper placement for adequate pain control.

Treatment and study plan

ON-Q soaker catheter system

Device

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.

Epidural (ropivicaine 0.25%)

Drug

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 names: Naropin

Primary outcomes

  1. 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.

  2. Use of Analgesic Narcotic

    Time frame: 1-7 days post operation

    Postoperative analgesic used each day over 7 day postoperative period.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Halyard Health

Registry information

Official study 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 Invasive Repair

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 22, 2013
Registry last updated
Apr 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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