A Study Comparing Two Methods of Placing an Interscalene Nerve Catheter for Postoperative Pain Control in Patients Who Undergo Open Shoulder Surgery.
| Status: | Completed |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | July 2012 |
| End Date: | June 2014 |
Comparison of In-Plane vs. Out-of-Plane Ultrasound-Guided Approach for Interscalene Nerve Catheters: a Prospective, Randomized Trial
This is a randomized, double-blinded, prospective study designed to compare two approaches
(in the plane of the ultrasound beam and out of the plane of the ultrasound beam) to placing
an interscalene nerve block and catheter for pain control after open shoulder surgery. Both
approaches have been used successfully but neither has been proven to be superior. Our
endpoints are pain scores, time for block placement, and catheter dislodgements. We
hypothesized that patients with the out-of-plane approach would have decreased pain and
fewer catheter dislodgements.
(in the plane of the ultrasound beam and out of the plane of the ultrasound beam) to placing
an interscalene nerve block and catheter for pain control after open shoulder surgery. Both
approaches have been used successfully but neither has been proven to be superior. Our
endpoints are pain scores, time for block placement, and catheter dislodgements. We
hypothesized that patients with the out-of-plane approach would have decreased pain and
fewer catheter dislodgements.
Interscalene nerve block is an effective method of analgesia for surgery of the upper
extremity. Perineural interscalene catheters offer the advantage of extended pain relief up
to 48 hours after shoulder surgery. This is a prospective, randomized trial designed to
compare two approaches (posterior and anterolateral) to interscalene continuous nerve
catheter placement for analgesia after open shoulder surgery (open rotator cuff repair,
total shoulder arthroplasty or revision, hemi-arthroplasty, or proximal humerus open
reduction internal fixation). Specifically, the objectives of this study are to compare
measured pain scores, opioid consumption, and catheter dislodgements. We hypothesize that
the anterolateral approach will produce lower pain scores, less opioid consumption, and
fewer catheter dislodgements.
All patients undergoing open shoulder surgery will be recruited and enrollment in the study
will not deviate from the current standard of care at Thomas Jefferson University Hospital.
All nerve blocks will be placed by a regional anesthesiologist or a fellow in regional
anesthesia. Patient medical history will be obtained and blocks will be placed per usual
protocol. Block efficacy will be assessed by physical exam immediately after placement by
the anesthesiologist and another member of the research team. Operative details, including
medications given, will be recorded.
Patient pain scores and medications given in the PACU will be recorded. Supplementary
analgesics will be available. Pain scores, medications given, and sensory examinations will
be recorded for 48 hours postoperatively. Data will be analyzed both at the conclusion of
the study and at several interims before that.
extremity. Perineural interscalene catheters offer the advantage of extended pain relief up
to 48 hours after shoulder surgery. This is a prospective, randomized trial designed to
compare two approaches (posterior and anterolateral) to interscalene continuous nerve
catheter placement for analgesia after open shoulder surgery (open rotator cuff repair,
total shoulder arthroplasty or revision, hemi-arthroplasty, or proximal humerus open
reduction internal fixation). Specifically, the objectives of this study are to compare
measured pain scores, opioid consumption, and catheter dislodgements. We hypothesize that
the anterolateral approach will produce lower pain scores, less opioid consumption, and
fewer catheter dislodgements.
All patients undergoing open shoulder surgery will be recruited and enrollment in the study
will not deviate from the current standard of care at Thomas Jefferson University Hospital.
All nerve blocks will be placed by a regional anesthesiologist or a fellow in regional
anesthesia. Patient medical history will be obtained and blocks will be placed per usual
protocol. Block efficacy will be assessed by physical exam immediately after placement by
the anesthesiologist and another member of the research team. Operative details, including
medications given, will be recorded.
Patient pain scores and medications given in the PACU will be recorded. Supplementary
analgesics will be available. Pain scores, medications given, and sensory examinations will
be recorded for 48 hours postoperatively. Data will be analyzed both at the conclusion of
the study and at several interims before that.
Inclusion Criteria:
- speaks English
Exclusion Criteria:
- children,
- neuropathy in operative arm
We found this trial at
1
site
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
Click here to add this to my saved trials
