Trial Outcomes & Findings for Pulmonary Function and Interscalene Block (NCT NCT02181296)

Results Overview

The primary outcome variable is the number of patients with paradoxical diaphragmatic movement ( as an indication for phrenic nerve blockade) as assessed by ultrasonographic evaluation of diaphragm

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

30 minutes after the block

Results posted on

2019-02-20

Participant Flow

Patients undergoing shoulder arthroscopy for rotator cuff repair were recruited from the orthopedic clinic of the University of Pennsylvania.

Participant milestones

Participant milestones
Measure	High Concentration Group 0.2% ropivacaine ropivacaine	Lower Concentration Group 0.1% ropivacaine ropivacaine
Overall Study STARTED	25	25
Overall Study COMPLETED	18	19
Overall Study NOT COMPLETED	7	6

Reasons for withdrawal

Reasons for withdrawal
Measure	High Concentration Group 0.2% ropivacaine ropivacaine	Lower Concentration Group 0.1% ropivacaine ropivacaine
Overall Study Lost to Follow-up	7	6

Baseline Characteristics

Pulmonary Function and Interscalene Block

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High Concentration Group n=25 Participants 0.2% ropivacaine ropivacaine	Lower Concentration Group n=25 Participants 0.1% ropivacaine ropivacaine	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants	21 Participants n=7 Participants	45 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Age, Continuous	40.5 years STANDARD_DEVIATION 15.8 • n=5 Participants	48.3 years STANDARD_DEVIATION 14.7 • n=7 Participants	44.4 years STANDARD_DEVIATION 15.25 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	15 Participants n=7 Participants	34 Participants n=5 Participants
Region of Enrollment United States	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 minutes after the block

Population: Paradoxical diaphragm movement at 30 min after the block. we had missing data on 3 patients ( 2 from the 0.1% group and 1 from the 0.2% group)

The primary outcome variable is the number of patients with paradoxical diaphragmatic movement ( as an indication for phrenic nerve blockade) as assessed by ultrasonographic evaluation of diaphragm

Outcome measures

Outcome measures
Measure	High Concentration Group n=24 Participants 0.2% ropivacaine ropivacaine	Lower Concentration Group n=23 Participants 0.1% ropivacaine ropivacaine
Number of Patients With Paradoxical Diaphragmatic Movement	16 Participants	8 Participants

SECONDARY outcome

Timeframe: within 30 minutes from arrival to PACU

Population: FVC measured within 30 minutes from arrival to PACU. We had missing data on three patients ( 2 in the 0.1% ropivacaine and 1 from the 0.2% ropivacaine group)

The percentage change in the FVC from preblock value to values measured in PACU. The negative value represents the decrease in the FVC value.

Outcome measures

Outcome measures
Measure	High Concentration Group n=24 Participants 0.2% ropivacaine ropivacaine	Lower Concentration Group n=23 Participants 0.1% ropivacaine ropivacaine
Percentage Change of Forced Vital Capacity (FVC) From Pre-block Value to Value Measures in PACU	-33.4 percentage of change in FVC Interval -38.0 to -16.0	-22 percentage of change in FVC Interval -31.1 to -5.0

SECONDARY outcome

Timeframe: within 30 minutes from arrival to PACU

Population: participants post-block within 30 minutes from arrival to PACU. we had three patients with missing data on these value and hence the discrepancy between the number of patients enrolled and the number of patients analyzed ( 2 patient from the 0.1% group had missing data and one patient from the 0.2% had missing data)

FEV1 was measured within 30 minutes of arrival to PACU. The outcomes represent the percentage change from the preoperative value to the value measured in PACU (Post-Anesthesia Care Unit). The negative value represents the decrease in the FEV1 value.

Outcome measures

Outcome measures
Measure	High Concentration Group n=24 Participants 0.2% ropivacaine ropivacaine	Lower Concentration Group n=23 Participants 0.1% ropivacaine ropivacaine
Percentage Change in Forced Expired Volume in First Second (FEV1) After the Block	-28 Percentage of change of FEV1 Interval -40.0 to -13.0	-20 Percentage of change of FEV1 Interval -29.0 to -8.0

SECONDARY outcome

Timeframe: 72 hours

Population: used nonparametric test to compare between the two groups. the discrepancy of the number of patients analyzed and participants have been previously explained

in the milligram equivalent of codeine, using web-based opioid dose converter

Outcome measures

Outcome measures
Measure	High Concentration Group n=24 Participants 0.2% ropivacaine ropivacaine	Lower Concentration Group n=23 Participants 0.1% ropivacaine ropivacaine
Opioid Requirements for 72 Hours After Surgery	55 milligrams Interval 25.0 to 75.0	102 milligrams Interval 65.0 to 150.0

Adverse Events

High Concentration Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lower Concentration 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. Nabil M Elkassabany

University of Pennsylvania

Phone: (215) 662-3793

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place