NCT02462382

Efficacy of Continuous Infusion Ropivacaine Interscalene Blocks

Completed Phase 4 Results posted Last updated 22 December 2020

What this trial tests

Phase 4 trial testing Arthroscopic Rotator Cuff Repair in Full-thickness Rotator Cuff Tear in 51 participants. Completed in 20 May 2016.

Timeline

1 September 2013

Primary endpoint
20 May 2016

20 May 2016

Quick facts

Lead sponsor	Orlando Health, Inc.
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	51
Start date	1 September 2013
Primary completion	20 May 2016
Estimated completion	20 May 2016
Sites	1 location across United States

Drugs / interventions tested

• Arthroscopic Rotator Cuff Repair
• Ropivacaine (ROPIVACAINE) — full drug profile →
• Saline

Conditions studied

• Full-thickness Rotator Cuff Tear — all drugs for Full-thickness Rotator Cuff Tear →

Sponsor

Orlando Health, Inc. — full company profile →

Who can join

18 and older, any sex, with Full-thickness Rotator Cuff Tear. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Visual Analog Scale Primary · During the first two Post Operative Days.

Shoulder Pain as measured by Visual Analog Scale, score 0-10. 0 equals no pain, 10 equals severe pain. Data not available for each tear size, all attempts were made to locate.

POD1 1cm incision

Group	Value	95% CI
Ropivacaine Infusion	3.5	2.2 – 4.8
Saline Infusion	5.9	5.0 – 6.9

POD 1 2cm incision

Group	Value	95% CI
Ropivacaine Infusion	3.1	2.1 – 4.2
Saline Infusion	5.2	4.3 – 6.1

POD 1 3cm incision

Group	Value	95% CI
Ropivacaine Infusion	4.0	2.8 – 5.1
Saline Infusion	5.4	4.4 – 6.3

POD 2 1cm incision

Group	Value	95% CI
Ropivacaine Infusion	2.9	1.8 – 4.0
Saline Infusion	4.0	3.0 – 4.9

POD 2 2cm incision

Group	Value	95% CI
Ropivacaine Infusion	3.1	1.8 – 4.3
Saline Infusion	3.6	2.5 – 4.7

POD 2 3 cm incision

Group	Value	95% CI
Ropivacaine Infusion	3.8	2.8 – 4.9
Saline Infusion	4.1	3.1 – 5.1

Mean Visual Analog Scale Score Secondary · Post Operative Days (POD) 3, 4 and 5.

Visual Analog Scale pain scale score 0-10. 0 equals no pain, 10 equals severe pain.

POD 3 1cm incision

Group	Value	95% CI
Ropivacaine Infusion	3.5	2.3 – 4.6
Saline Infusion	3.3	2.3 – 4.3

POD 3 2cm incision

Group	Value	95% CI
Ropivacaine Infusion	3.3	2.2 – 4.4
Saline Infusion	3.1	2.4 – 4.4

POD 3 3cm incision

Group	Value	95% CI
Ropivacaine Infusion	3.2	2.2 – 4.2
Saline Infusion	3.4	2.4 – 4.4

POD 4 1 cm incision

Group	Value	95% CI
Ropivacaine Infusion	2.6	1.6 – 3.7
Saline Infusion	3.5	2.5 – 4.5

POD 4 2cm incision

Group	Value	95% CI
Ropivacaine Infusion	2.6	1.5 – 3.7
Saline Infusion	3.2	2.3 – 4.1

POD 4 3cm incision

Group	Value	95% CI
Ropivacaine Infusion	2.8	1.6 – 4.1
Saline Infusion	3.3	2.4 – 4.3

POD 5 1cm incision

Group	Value	95% CI
Ropivacaine Infusion	2.3	1.4 – 3.2
Saline Infusion	3.0	2.1 – 3.9

POD 5 2cm incision

Group	Value	95% CI
Ropivacaine Infusion	2.2	1.2 – 3.2
Saline Infusion	2.6	1.7 – 3.5

Oxycodone Consumption Secondary · Post operative days 1 and 2.

POD 1

Group	Value	95% CI
Ropivacaine Infusion	5.8	4.1 – 7.5
Saline Infusion	8.3	6.6 – 10.0

POD 2

Group	Value	95% CI
Ropivacaine Infusion	5.8	4.1 – 7.6
Saline Infusion	7.9	6.2 – 9.5

Oxycodone Consumption After the First Two Postoperative Days. Secondary · Post Operative Days 3, 4 and 5.

POD 3

Group	Value	95% CI
Ropivacaine Infusion	5.5	3.9 – 7.0
Saline Infusion	5.8	4.2 – 7.5

POD 4

Group	Value	95% CI
Ropivacaine Infusion	3.9	2.6 – 5.1
Saline Infusion	4.7	3.2 – 6.2

POD 5

Group	Value	95% CI
Ropivacaine Infusion	3.6	2.4 – 4.8
Saline Infusion	3.7	2.4 – 5.1

Sponsor's own description

Arthroscopic rotator cuff repair is a common and painful procedure routinely performed on an outpatient basis. Postoperative pain control regimens can include narcotic pain medicine, non-steroidal anti-inflammatory medications and regional anesthesia such as an interscalene block (ISB). Regional blocks such as ISB can safely provide complete pain relief for the shoulder and upper extremity for eight to twelve hours1. However, the shoulder is still very painful when the block wears off. The purpose of this study is to:

1. Examine the efficacy of continuous infusion scalene block ropivacaine catheters during the first two days after arthroscopic rotator cuff repair.
2. Examine narcotic consumption after continuous infusion scalene block ropivacaine and placebo catheters after arthroscopic rotator cuff repair.
3. Evaluate for any continued pain relief benefit of continuous infusion scalene block ropivacaine catheters during the three days after the infusion catheters have finished.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.