Trial Outcomes & Findings for The Effect of Interscalene Peripheral Nerve Block With 0.25% Bupivacaine vs 0.125% Bupivacaine on Lung Function (NCT NCT01429584)

Results Overview

Lung function was evaluated by examining diaphragm movement using ultrasound imaging and change in room air oxygen saturation (SpO2). Diaphragm movement was assessed using ultrasound as Normal (diaphragm moves caudad with inspiration), Abnormal (diaphragm does not move caudad with inspiration), and Paradoxical (diaphragm moves cephalad with inspiration). Both diaphragm function and room air SpO2 were assessed prior to any intervention to establish a baseline, and again on discharge from the PACU, within 5 hours of the completion of surgery.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

At discharge from the post-anesthesia care unit, within 5 hours of the completion of surgery

Results posted on

2013-12-19

Participant Flow

Participant milestones

Participant milestones
Measure	0.25% Bupivacaine interscalene nerve block with 0.25% bupivacaine	0.125% Bupivacaine interscalene nerve block with 0.125% bupivacaine
Overall Study STARTED	15	15
Overall Study COMPLETED	14	14
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	0.25% Bupivacaine interscalene nerve block with 0.25% bupivacaine	0.125% Bupivacaine interscalene nerve block with 0.125% bupivacaine
Overall Study Withdrawal by Subject	1	0
Overall Study Protocol Violation	0	1

Baseline Characteristics

The Effect of Interscalene Peripheral Nerve Block With 0.25% Bupivacaine vs 0.125% Bupivacaine on Lung Function

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	0.25% Bupivacaine n=15 Participants interscalene nerve block with 0.25% bupivacaine	0.125% Bupivacaine n=15 Participants interscalene nerve block with 0.125% bupivacaine	Total n=30 Participants Total of all reporting groups
Age, Continuous	55.6 years STANDARD_DEVIATION 9.3 • n=93 Participants	53.6 years STANDARD_DEVIATION 6.3 • n=4 Participants	54.7 years STANDARD_DEVIATION 7.9 • n=27 Participants
Sex: Female, Male Female	7 Participants n=93 Participants	6 Participants n=4 Participants	13 Participants n=27 Participants
Sex: Female, Male Male	8 Participants n=93 Participants	9 Participants n=4 Participants	17 Participants n=27 Participants
Region of Enrollment United States	15 participants n=93 Participants	15 participants n=4 Participants	30 participants n=27 Participants

PRIMARY outcome

Timeframe: At discharge from the post-anesthesia care unit, within 5 hours of the completion of surgery

Population: Power analysis was performed and a drop-out rate of 10% was anticipated.

Lung function was evaluated by examining diaphragm movement using ultrasound imaging and change in room air oxygen saturation (SpO2). Diaphragm movement was assessed using ultrasound as Normal (diaphragm moves caudad with inspiration), Abnormal (diaphragm does not move caudad with inspiration), and Paradoxical (diaphragm moves cephalad with inspiration). Both diaphragm function and room air SpO2 were assessed prior to any intervention to establish a baseline, and again on discharge from the PACU, within 5 hours of the completion of surgery.

Outcome measures

Outcome measures
Measure	0.25% Bupivacaine n=14 Participants interscalene nerve block with 0.25% bupivacaine	0.125% Bupivacaine n=14 Participants interscalene nerve block with 0.125% bupivacaine
Abnormal Lung Function	11 participants w/ abnormal diaphragm fxn	3 participants w/ abnormal diaphragm fxn

SECONDARY outcome

Timeframe: At discharge from the post-anesthesia care unit, within 5 hours of the completion of surgery

Population: Same as other outcome measures.

Pain relief was assessed by recording the amount of opioid administered intraoperatively and in the PACU. The Visual Analogue Score of pain scores (0-10, with 0 being no pain and 10 being the worst pain imaginable) were recorded at the time of discharge from the PACU, within 5 hours of the completion of surgery.

Outcome measures

Outcome measures
Measure	0.25% Bupivacaine n=14 Participants interscalene nerve block with 0.25% bupivacaine	0.125% Bupivacaine n=14 Participants interscalene nerve block with 0.125% bupivacaine
Pain Relief	0 Visual Analogue Scale for pain Standard Deviation 0	0.7 Visual Analogue Scale for pain Standard Deviation 1.1

SECONDARY outcome

Timeframe: Within 30 days

Population: Same as other outcome measures

A follow-up phone call was made to patients within 30 days of surgery to assess the presence of any complications related to the block and overall satisfaction with pain control. Overall satisfaction was assessed on a 7-point Likert scale of 1-not at all satisfied with pain control 2-mostly unsatisfied with pain control 3-slightly unsatisfied with pain control 4-no opinion 5-slightly satisfied with pain control 6-mostly satisfied with pain control 7-completely satisfied with pain control.

Outcome measures

Outcome measures
Measure	0.25% Bupivacaine n=14 Participants interscalene nerve block with 0.25% bupivacaine	0.125% Bupivacaine n=14 Participants interscalene nerve block with 0.125% bupivacaine
Satisfaction With Pain Control	6.6 Likert Satisfaction Scale Standard Deviation 0.5	6.6 Likert Satisfaction Scale Standard Deviation 1.1

Adverse Events

0.25% Bupivacaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

0.125% Bupivacaine

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. Elizabeth Thackeray

University of Utah Department of Anesthesiology

Phone: (801) 581-6393

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place