Trial Outcomes & Findings for Continuous Interscalene Block Results in Superior Recovery Throughout the First Postoperative Week (NCT NCT01881776)

NCT ID: NCT01881776

Last Updated: 2014-06-04

Results Overview

The effects of the three anesthetic techniques (continuous interscalene brachial plexus block (CISB), single interscalene brachial plexus block (SISB), or general anesthesia (GA)) when used intraoperatively as a sole anesthesia modality were studied on postoperative pain (highest NRS pain rating)

• Recruitment status: COMPLETED
• Study phase: EARLY_PHASE1
• Target enrollment: 71 participants
• Primary outcome timeframe: throughout the first postoperative week on days 1, 2, 3, and 7
• Results posted on: 2014-06-04

Participant Flow

St Luke's-Roosevelt Hospital Center between August 2011 and June 2012

One patient enrolled preferred to get SISB instead of GA and was therefore not randomized to treatment.

Participant milestones

Measure	Single ISB (SISB) Group Patients in this group received single injection (SISB) interscalene brachial plexus block ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle. For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.	Continuous ISB (CISB) Group Patients in this group received continuous (CISB) interscalene brachial plexus block ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle. For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.	General Anesthesia (GA) Group Patients in this group received general anesthesia (GA)
Overall Study STARTED	24	24	22
Overall Study COMPLETED	23	20	20
Overall Study NOT COMPLETED	1	4	2

Reasons for withdrawal

Measure	Single ISB (SISB) Group Patients in this group received single injection (SISB) interscalene brachial plexus block ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle. For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.	Continuous ISB (CISB) Group Patients in this group received continuous (CISB) interscalene brachial plexus block ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle. For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.	General Anesthesia (GA) Group Patients in this group received general anesthesia (GA)
Overall Study Lost to Follow-up	1	2	1
Overall Study Protocol Violation	0	2	1

Baseline Characteristics

Continuous Interscalene Block Results in Superior Recovery Throughout the First Postoperative Week

Baseline characteristics by cohort

Measure	Single ISB (SISB) Group n=24 Participants Patients in this group received single injection (SISB) interscalene brachial plexus block ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle. For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.	Continuous ISB (CISB) Group n=24 Participants Patients in this group received continuous (CISB) interscalene brachial plexus block ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle. For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.	General Anesthesia (GA) Group n=22 Participants Patients in this group received general anesthesia (GA)	Total n=70 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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants	20 Participants n=7 Participants	19 Participants n=5 Participants	58 Participants n=4 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	12 Participants n=4 Participants
Age, Continuous	57 years STANDARD_DEVIATION 9 • n=5 Participants	56 years STANDARD_DEVIATION 10 • n=7 Participants	52 years STANDARD_DEVIATION 12 • n=5 Participants	55 years STANDARD_DEVIATION 11 • n=4 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	17 Participants n=7 Participants	14 Participants n=5 Participants	44 Participants n=4 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	26 Participants n=4 Participants
Region of Enrollment United States	24 participants n=5 Participants	24 participants n=7 Participants	22 participants n=5 Participants	70 participants n=4 Participants

PRIMARY outcome

Timeframe: throughout the first postoperative week on days 1, 2, 3, and 7

The effects of the three anesthetic techniques (continuous interscalene brachial plexus block (CISB), single interscalene brachial plexus block (SISB), or general anesthesia (GA)) when used intraoperatively as a sole anesthesia modality were studied on postoperative pain (highest NRS pain rating)

Outcome measures

Measure	Single ISB (SISB) Group n=23 Participants Patients in this group received single injection (SISB) interscalene brachial plexus block ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle. For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.	Continuous ISB (CISB) Group n=20 Participants Patients in this group received continuous (CISB) interscalene brachial plexus block ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle. For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.	General Anesthesia (GA) Group n=20 Participants Patients in this group received general anesthesia (GA)
Patients With Pain: Numerical Rating Scale (NRS-11(0-10): 0:no Pain and 10:Severe/Worst Pain) ≥ 4	19 participants Interval 18.0 to 25.0	5 participants Interval 18.0 to 25.0	11 participants Interval 18.0 to 25.0

SECONDARY outcome

Timeframe: throughout the first postoperative week

The effects of the three anesthetic techniques (SISB, CISB, and GA) when used intraoperatively as a sole anesthesia modality were studied on postoperative pain (time-to-first pain).

Outcome measures

Measure	Single ISB (SISB) Group n=23 Participants Patients in this group received single injection (SISB) interscalene brachial plexus block ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle. For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.	Continuous ISB (CISB) Group n=20 Participants Patients in this group received continuous (CISB) interscalene brachial plexus block ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle. For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.	General Anesthesia (GA) Group n=20 Participants Patients in this group received general anesthesia (GA)
Time-to-first Pain	11 hours Standard Deviation 5	26 hours Standard Deviation 24	2 hours Standard Deviation 3

SECONDARY outcome

Timeframe: throughout the first postoperative week

The effects of the three anesthetic techniques (SISB, CISB, and GA) when used intraoperatively as a sole anesthesia modality were studied on postoperative pain (analgesic consumption).

Outcome measures

Measure	Single ISB (SISB) Group n=23 Participants Patients in this group received single injection (SISB) interscalene brachial plexus block ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle. For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.	Continuous ISB (CISB) Group n=20 Participants Patients in this group received continuous (CISB) interscalene brachial plexus block ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle. For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.	General Anesthesia (GA) Group n=20 Participants Patients in this group received general anesthesia (GA)
The Number of Patients Consume ≥1 Dose of Analgesics	16 participants	12 participants	13 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: throughout the first postoperative week (how many patients left PACU immediately just after the operation)

To compare the recovery profile of patients receiving CISB, SISB, or GA for arthroscopic rotator cuff repair surgery throughout the first postoperative week by using fast-tracked PACU bypass rate

Outcome measures

Measure	Single ISB (SISB) Group n=23 Participants Patients in this group received single injection (SISB) interscalene brachial plexus block ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle. For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.	Continuous ISB (CISB) Group n=20 Participants Patients in this group received continuous (CISB) interscalene brachial plexus block ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle. For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.	General Anesthesia (GA) Group n=20 Participants Patients in this group received general anesthesia (GA)
Fast-tracked Postoperative Care Unit (PACU) Bypass Patient Number	20 participants	19 participants	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: throughout the first postoperative week (how long patients stayed in PACU just after the operation)

To compare the recovery profile of patients receiving CISB, SISB, or GA for arthroscopic rotator cuff repair surgery throughout the first postoperative week by using length of PACU stay.

Outcome measures

Measure	Single ISB (SISB) Group n=23 Participants Patients in this group received single injection (SISB) interscalene brachial plexus block ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle. For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.	Continuous ISB (CISB) Group n=20 Participants Patients in this group received continuous (CISB) interscalene brachial plexus block ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle. For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.	General Anesthesia (GA) Group n=20 Participants Patients in this group received general anesthesia (GA)
Length of PACU Stay	30 minutes Standard Deviation 42	20 minutes Standard Deviation 31	165 minutes Standard Deviation 118

OTHER_PRE_SPECIFIED outcome

Timeframe: throughout the first postoperative week (how long patients stayed in the hospital (includes PACU and hospital time)

To compare the recovery profile of patients receiving CISB, SISB, or GA for arthroscopic rotator cuff repair surgery throughout the first postoperative week by using time-to-discharge home.

Outcome measures

Measure	Single ISB (SISB) Group n=23 Participants Patients in this group received single injection (SISB) interscalene brachial plexus block ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle. For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.	Continuous ISB (CISB) Group n=20 Participants Patients in this group received continuous (CISB) interscalene brachial plexus block ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle. For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.	General Anesthesia (GA) Group n=20 Participants Patients in this group received general anesthesia (GA)
Time to Discharge Home	115 minutes Standard Deviation 109	94 minutes Standard Deviation 55	302 minutes Standard Deviation 249

OTHER_PRE_SPECIFIED outcome

Timeframe: first postoperative week (on day 7)

To compare the recovery profile of patients receiving CISB, SISB, or GA for arthroscopic rotator cuff repair surgery throughout the first postoperative week by using sleep duration.

Outcome measures

Measure	Single ISB (SISB) Group n=23 Participants Patients in this group received single injection (SISB) interscalene brachial plexus block ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle. For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.	Continuous ISB (CISB) Group n=20 Participants Patients in this group received continuous (CISB) interscalene brachial plexus block ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle. For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.	General Anesthesia (GA) Group n=20 Participants Patients in this group received general anesthesia (GA)
Total Hours of Sleep	5 hours Standard Deviation 2	7 hours Standard Deviation 1	6 hours Standard Deviation 2

Adverse Events

Single ISB (SISB) Group

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Continuous ISB (CISB) Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

General Anesthesia (GA) Group

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Single ISB (SISB) Group n=23 participants at risk Patients in this group received single injection (SISB) interscalene brachial plexus block ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle. For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.	Continuous ISB (CISB) Group n=20 participants at risk Patients in this group received continuous (CISB) interscalene brachial plexus block ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle. For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.	General Anesthesia (GA) Group n=20 participants at risk Patients in this group received general anesthesia (GA)
Gastrointestinal disorders PONV	21.7% 5/23 • Number of events 5 • Throughout the first postoperative week Postoperative Dizziness, Nausea and Vomiting (PONV): All these symptoms were asked altogether to the patients and assessed only as positive or negative	0.00% 0/20 • Throughout the first postoperative week Postoperative Dizziness, Nausea and Vomiting (PONV): All these symptoms were asked altogether to the patients and assessed only as positive or negative	10.0% 2/20 • Number of events 2 • Throughout the first postoperative week Postoperative Dizziness, Nausea and Vomiting (PONV): All these symptoms were asked altogether to the patients and assessed only as positive or negative

Other adverse events

Adverse event data not reported

Additional Information

Dr.Admir Hadzic

StLukeNY

Phone: 212-665-1400

Email: admir@nysora.com

Results disclosure agreements

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