Trial Outcomes & Findings for A Study Comparing Two Methods of Placing an Interscalene Nerve Catheter for Postoperative Pain Control in Patients Who Undergo Open Shoulder Surgery. (NCT NCT01696188)

NCT ID: NCT01696188

Last Updated: 2015-11-16

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 84 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2015-11-16

Participant Flow

Participant milestones

Measure	In-plane Group This group will receive an interscalene catheter placed with in-plane approach. interscalene nerve catheter	Out-of-plane Group This group will receive an interscalene catheter with an out-of-plane approach. interscalene nerve catheter
Overall Study STARTED	41	43
Overall Study COMPLETED	40	42
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	In-plane Group This group will receive an interscalene catheter placed with in-plane approach. interscalene nerve catheter	Out-of-plane Group This group will receive an interscalene catheter with an out-of-plane approach. interscalene nerve catheter
Overall Study Protocol Violation	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	In-plane Group n=40 Participants This group will receive an interscalene catheter placed with in-plane approach. interscalene nerve catheter	Out-of-plane Group n=42 Participants This group will receive an interscalene catheter with an out-of-plan approach. interscalene nerve catheter	Total n=82 Participants Total of all reporting groups
Age, Continuous	67.1 years STANDARD_DEVIATION 10.7 • n=5 Participants	63.8 years STANDARD_DEVIATION 12 • n=7 Participants	65.2 years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	17 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	25 Participants n=7 Participants	40 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants	42 participants n=7 Participants	82 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

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

Outcome measures

Measure	In-plane Group n=40 Participants This group will receive an interscalene catheter placed with in-plane approach. interscalene nerve catheter	Out-of-plane Group n=42 Participants This group will receive an interscalene catheter with an out-of-plane approach. interscalene nerve catheter
Visual Analog Scale Pain Scores	1.3 units on a scale Interval 0.0 to 3.8	1.5 units on a scale Interval 0.0 to 4.5

SECONDARY outcome

Timeframe: 24 hours

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

Outcome measures

Measure	In-plane Group n=40 Participants This group will receive an interscalene catheter placed with in-plane approach. interscalene nerve catheter	Out-of-plane Group n=42 Participants This group will receive an interscalene catheter with an out-of-plane approach. interscalene nerve catheter
Catheter Dislodgements	4 participants	1 participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	In-plane Group n=40 Participants This group will receive an interscalene catheter placed with in-plane approach. interscalene nerve catheter	Out-of-plane Group n=42 Participants This group will receive an interscalene catheter with an out-of-plane approach. interscalene nerve catheter
Opioid Consumption	25.0 mg IV morphine equivalents Interval 12.5 to 65.0	35.3 mg IV morphine equivalents Interval 24.8 to 70.7

SECONDARY outcome

Timeframe: immediately post-procedure

Calculate the time to perform the nerve block procedure.

Outcome measures

Measure	In-plane Group n=40 Participants This group will receive an interscalene catheter placed with in-plane approach. interscalene nerve catheter	Out-of-plane Group n=42 Participants This group will receive an interscalene catheter with an out-of-plane approach. interscalene nerve catheter
Time for Block Placement	296 seconds Interval 255.0 to 337.0	257 seconds Interval 238.0 to 277.0

Adverse Events

In-plane Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Out-of-plane Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Eric Schwenk

Sidney Kimmel Medical College at Thomas Jefferson University

Phone: 215-955-6161

Email: Eric.Schwenk@jefferson.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place