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

Primary Purpose

Pectus Excavatum

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ON-Q soaker catheter system
Epidural (ropivicaine 0.25%)
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pectus Excavatum

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic in Arizona

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Thoracic epidural

ON-Q soaker catheter system

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Hospital Length of Stay
Hospital length of stay was measured from the day of surgery (day 0) through postoperative day 11.
Use of Analgesic Narcotic
Postoperative analgesic used each day over 7 day postoperative period.

Secondary Outcome Measures

Mean Daily Pain Score
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.

Full Information

First Posted
February 28, 2013
Last Updated
February 15, 2017
Sponsor
Mayo Clinic
Collaborators
Halyard Health
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1. Study Identification

Unique Protocol Identification Number
NCT01816477
Brief Title
Post Operative Pain Control Using Ropivacaine and the ON-Q System in the Adult Pectus Excavatum Patient
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 Invasive Repair
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
April 2013 (Actual)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Halyard Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pectus Excavatum

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thoracic epidural
Arm Type
Active Comparator
Arm Description
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.
Arm Title
ON-Q soaker catheter system
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
ON-Q soaker catheter system
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Epidural (ropivicaine 0.25%)
Other Intervention Name(s)
Naropin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hospital Length of Stay
Description
Hospital length of stay was measured from the day of surgery (day 0) through postoperative day 11.
Time Frame
Up to 11 days post operation
Title
Use of Analgesic Narcotic
Description
Postoperative analgesic used each day over 7 day postoperative period.
Time Frame
1-7 days post operation
Secondary Outcome Measure Information:
Title
Mean Daily Pain Score
Description
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.
Time Frame
Days 1-7 post operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawn E Jaroszewski, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27621865
Citation
Jaroszewski DE, Temkit M, Ewais MM, Luckritz TC, Stearns JD, Craner RC, Gaitan BD, Ramakrishna H, Thunberg CA, Weis RA, Myers KM, Merritt MV, Rosenfeld DM. Randomized trial of epidural vs. subcutaneous catheters for managing pain after modified Nuss in adults. J Thorac Dis. 2016 Aug;8(8):2102-10. doi: 10.21037/jtd.2016.06.62.
Results Reference
result

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

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