A Study Comparing Two Methods of Placing an Interscalene Nerve Catheter for Postoperative Pain Control in Patients Who Undergo Open Shoulder Surgery.

Shoulder Pain Clinical Trial

Official title:

Comparison of In-Plane vs. Out-of-Plane Ultrasound-Guided Approach for Interscalene Nerve Catheters: a Prospective, Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01696188
• Other study ID #: 12D.328
• Status: Completed
• Phase: N/A
• First received: September 13, 2012
• Last updated: October 14, 2015
• Start date: July 2012
• Est. completion date: June 2014

Study information

• Verified date: October 2015
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• speaks English

Exclusion Criteria:

• children,

• neuropathy in operative arm

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

Device:
• interscalene nerve catheter

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

References & Publications (3)

Antonakakis JG, Sites BD, Shiffrin J. Ultrasound-guided posterior approach for the placement of a continuous interscalene catheter. Reg Anesth Pain Med. 2009 Jan-Feb;34(1):64-8. doi: 10.1016/AAP.0b013e3181933a53. — View Citation

Fredrickson MJ, Ball CM, Dalgleish AJ. Posterior versus anterolateral approach interscalene catheter placement: a prospective randomized trial. Reg Anesth Pain Med. 2011 Mar-Apr;36(2):125-33. — View Citation

Mariano ER, Loland VJ, Ilfeld BM. Interscalene perineural catheter placement using an ultrasound-guided posterior approach. Reg Anesth Pain Med. 2009 Jan-Feb;34(1):60-3. doi: 10.1097/AAP.0b013e3181933af7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale Pain Scores	Pain was rated from 0 (no pain) to 10 (worst pain imaginable)	24 hours	No
Secondary	Catheter Dislodgements	Inspect the peripheral nerve catheters at 24 hours postoperatively and assess for being in-place or not.	24 hours	No
Secondary	Opioid Consumption	Calculate the total amount of opioid consumed in the first 48 hours after surgery using a standard opioid conversion scale. 1 mg hydrocodone = 0.33 mg IV morphine, 1 mg oxycodone = 0.50 mg morphine IV, 1 mg hydromorphone PO = 1.33 mg morphine IV, 1 mcg fentanyl = 0.1 mg morphine IV, 1 mg hydromorphone IV = 6.67 mg morphine IV	48 hours	No
Secondary	Time for Block Placement	Calculate the time to perform the nerve block procedure.	immediately post-procedure	No