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Completed

NCT Number: NCT01696188

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • speaks English

Exclusion criteria

  • children,
  • neuropathy in operative arm

Treatment and study plan

interscalene nerve catheter

Device

Other names: Peripheral nerve catheter kit, B Braun (Bethlehem, PA)

Primary outcomes

  1. Visual Analog Scale Pain Scores

    Time frame: 24 hours

    Pain was rated from 0 (no pain) to 10 (worst pain imaginable)

Secondary outcomes

  1. Catheter Dislodgements

    Time frame: 24 hours

    Inspect the peripheral nerve catheters at 24 hours postoperatively and assess for being in-place or not.

  2. Opioid Consumption

    Time frame: 48 hours

    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

  3. Time for Block Placement

    Time frame: immediately post-procedure

    Calculate the time to perform the nerve block procedure.

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 28, 2012
Registry last updated
Nov 16, 2015

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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