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

• Sponsor: St. Luke's-Roosevelt Hospital Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01881776
• Collaborator: Baxter Healthcare Corporation (Industry)
• Enrollment: 71
• Location: 1
• Arms: 3
• Duration (Months): 10
• Patients Per Site Per Month: 7.1

Study Details

Study Description

Brief Summary

The investigators undertook this prospective, randomized trial to compare the recovery profile throughout the first postoperative week in patients receiving continuous (CISB) interscalene brachial plexus block, single injection (SISB), or general anesthesia (GA) for arthroscopic rotator cuff repair surgery. Specifically, the effects of the three anesthetic techniques when used intraoperatively as a sole anesthesia modality were studied on postoperative pain, time-to-first pain, analgesic consumption, fast-tracked PACU bypass rate, length of PACU stay, time-to-discharge home, sleep duration, and related adverse effects. The investigators hypothesized that CISB results in a superior postoperative recovery profile as compared to SISB or GA alone.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain; Adverse Effects	Procedure: ISB	Early Phase 1

Detailed Description

Background The advantages of single injection (SISB) and continuous interscalene brachial plexus block (CISB) over general anesthesia (GA) only have been previously reported. However, few studies extended their observations beyond 48 postoperative hours, and no study has compared the effects of SISB and CISB as sole anesthesia modalities with GA only. We undertook this randomized trial to compare the recovery profile of patients receiving SISB, CISB or GA for arthroscopic rotator cuff repair surgery through the first postoperative week. Our primary hypothesis was that highest NRS pain rating (worst pain score) at the end of the study week is lower for patients in the CISB group than for patients in the SISB or GA groups.

Methods After Institutional Review Board approval and informed consents were obtained, 71 patients of American Society of Anesthesiologists (ASA) physical status I-III, ≥18 years of age, and BMI≤35 kg/m2, scheduled for elective outpatient arthroscopic rotator cuff repair, were enrolled. CISB patients received 20 mL of 0.5% ropivacaine as bolus through the catheter whereas SISB patients received the same volume of injection through a needle. CISB patients received an infusion of 0.2% ropivacaine at 5mL/h with a patient controlled bolus of 5 mL hourly. GA only patients received a standardized general anesthetic. All patients were prescribed acetaminophen (500mg) with hydrocodone (7.5mg) every 4h as needed. CISB was discontinued 48 h after surgery. Postoperative highest pain scores (NRS) through the first postoperative week, time-to-first pain, analgesic consumption, fast-tracked postoperative care unit (PACU) bypass rate, length of PACU stay, time-to-discharge home, sleep duration, and related adverse effects were recorded in the PACU and at home on postoperative days 1, 2, 3, and 7.

Study Design

• Study Type: Interventional
• Actual Enrollment: 71 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Supportive Care
• Official Title: Continuous Interscalene Block in Patients Having Outpatient Rotator Cuff Repair Surgery: a Prospective Randomized Trial
• Study Start Date: Aug 1, 2011
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Single ISB (SISB) group Patients in this group received single injection (SISB) interscalene brachial plexus block	Procedure: 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.; Other Names: SISB needle (Stimuplex®A, B Braun) CISB needle and catheter (Contiplex® Tuohy, B. Braun)
Active Comparator: Continuous ISB (CISB) group Patients in this group received continuous (CISB) interscalene brachial plexus block	Procedure: 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.; Other Names: SISB needle (Stimuplex®A, B Braun) CISB needle and catheter (Contiplex® Tuohy, B. Braun)
No Intervention: General anesthesia (GA) group Patients in this group received general anesthesia (GA)

Outcome Measures

Primary Outcome Measures

1. Patients With Pain: Numerical Rating Scale (NRS-11(0-10): 0:no Pain and 10:Severe/Worst Pain) ≥ 4 [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)

Secondary Outcome Measures

1. Time-to-first Pain [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).

2. The Number of Patients Consume ≥1 Dose of Analgesics [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).

Other Outcome Measures

1. Fast-tracked Postoperative Care Unit (PACU) Bypass Patient Number [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

2. Length of PACU Stay [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.

3. Time to Discharge Home [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.

4. Total Hours of Sleep [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

American Society of Anesthesiologists (ASA) physical status I-III patients

≥ 18 years of age BMI ≤ 35 kg/m2 Scheduled for elective arthroscopic shoulder surgery

Exclusion Criteria:

Patients who were undertaken open shoulder procedures Patients with difficulty understanding the instructions for using the anesthetic infusion pump and/or pain scales Patients with contraindications to regional anesthesia (e.g., allergy to a local anesthetic (LA), local infection, coagulopathy) Patients with significant neurologic disorders of the upper extremity, psychiatric or cognitive disorders, history of substance abuse or chronic opioid use

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St Luke's Roosevelt Hospital Center	New York	New York	United States	10025

Sponsors and Collaborators

• St. Luke's-Roosevelt Hospital Center
• Baxter Healthcare Corporation

Investigators

• Principal Investigator: Admir Hadzic, MD,PhD,Prof, St. Luke's-Roosevelt Hospital Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: St. Luke's-Roosevelt Hospital Center
• ClinicalTrials.gov Identifier: NCT01881776
• Other Study ID Numbers: 10142
• First Posted: Jun 20, 2013
• Last Update Posted: Jun 4, 2014
• Last Verified: Jul 1, 2013

• Keywords provided by St. Luke's-Roosevelt Hospital Center: Single injection interscalene brachial plexus block; Continuous interscalene brachial plexus block; General anesthesia; Postoperative pain; Recovery profile
• Additional relevant MeSH terms: Pain, Postoperative

Study Results

Participant Flow

Recruitment Details	St Luke's-Roosevelt Hospital Center between August 2011 and June 2012
Pre-assignment Detail	One patient enrolled preferred to get SISB instead of GA and was therefore not randomized to treatment.

Arm/Group Title	Single ISB (SISB) Group	Continuous ISB (CISB) Group	General Anesthesia (GA) Group
Arm/Group Description	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.	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.	Patients in this group received general anesthesia (GA)
Period Title: Overall Study
STARTED	24	24	22
COMPLETED	23	20	20
NOT COMPLETED	1	4	2

Baseline Characteristics

Arm/Group Title	Single ISB (SISB) Group	Continuous ISB (CISB) Group	General Anesthesia (GA) Group	Total
Arm/Group Description	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.	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.	Patients in this group received general anesthesia (GA)	Total of all reporting groups
Overall Participants	24	24	22	70
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	19 79.2%	20 83.3%	19 86.4%	58 82.9%
>=65 years	5 20.8%	4 16.7%	3 13.6%	12 17.1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57 (9)	56 (10)	52 (12)	55 (11)
Sex: Female, Male (Count of Participants)
Female	13 54.2%	17 70.8%	14 63.6%	44 62.9%
Male	11 45.8%	7 29.2%	8 36.4%	26 37.1%
Region of Enrollment (participants) [Number]
United States	24 100%	24 100%	22 100%	70 100%

Outcome Measures

1. Primary Outcome

Title	Patients With Pain: Numerical Rating Scale (NRS-11(0-10): 0:no Pain and 10:Severe/Worst Pain) ≥ 4
Description	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)
Time Frame	throughout the first postoperative week on days 1, 2, 3, and 7

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single ISB (SISB) Group	Continuous ISB (CISB) Group	General Anesthesia (GA) Group
Arm/Group Description	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.	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.	Patients in this group received general anesthesia (GA)
Measure Participants	23	20	20
Number [participants]	19 79.2%	5 20.8%	11 50%

2. Secondary Outcome

Title	Time-to-first Pain
Description	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).
Time Frame	throughout the first postoperative week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single ISB (SISB) Group	Continuous ISB (CISB) Group	General Anesthesia (GA) Group
Arm/Group Description	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.	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.	Patients in this group received general anesthesia (GA)
Measure Participants	23	20	20
Mean (Standard Deviation) [hours]	11 (5)	26 (24)	2 (3)

3. Secondary Outcome

Title	The Number of Patients Consume ≥1 Dose of Analgesics
Description	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).
Time Frame	throughout the first postoperative week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single ISB (SISB) Group	Continuous ISB (CISB) Group	General Anesthesia (GA) Group
Arm/Group Description	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.	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.	Patients in this group received general anesthesia (GA)
Measure Participants	23	20	20
Number [participants]	16 66.7%	12 50%	13 59.1%

4. Other Pre-specified Outcome

Title	Fast-tracked Postoperative Care Unit (PACU) Bypass Patient Number
Description	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
Time Frame	throughout the first postoperative week (how many patients left PACU immediately just after the operation)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single ISB (SISB) Group	Continuous ISB (CISB) Group	General Anesthesia (GA) Group
Arm/Group Description	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.	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.	Patients in this group received general anesthesia (GA)
Measure Participants	23	20	20
Number [participants]	20 83.3%	19 79.2%	0 0%

5. Other Pre-specified Outcome

Title	Length of PACU Stay
Description	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.
Time Frame	throughout the first postoperative week (how long patients stayed in PACU just after the operation)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single ISB (SISB) Group	Continuous ISB (CISB) Group	General Anesthesia (GA) Group
Arm/Group Description	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.	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.	Patients in this group received general anesthesia (GA)
Measure Participants	23	20	20
Mean (Standard Deviation) [minutes]	30 (42)	20 (31)	165 (118)

6. Other Pre-specified Outcome

Title	Time to Discharge Home
Description	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.
Time Frame	throughout the first postoperative week (how long patients stayed in the hospital (includes PACU and hospital time)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single ISB (SISB) Group	Continuous ISB (CISB) Group	General Anesthesia (GA) Group
Arm/Group Description	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.	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.	Patients in this group received general anesthesia (GA)
Measure Participants	23	20	20
Mean (Standard Deviation) [minutes]	115 (109)	94 (55)	302 (249)

7. Other Pre-specified Outcome

Title	Total Hours of Sleep
Description	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.
Time Frame	first postoperative week (on day 7)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single ISB (SISB) Group	Continuous ISB (CISB) Group	General Anesthesia (GA) Group
Arm/Group Description	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.	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.	Patients in this group received general anesthesia (GA)
Measure Participants	23	20	20
Mean (Standard Deviation) [hours]	5 (2)	7 (1)	6 (2)

Adverse Events

Time Frame	Throughout the first postoperative week
Adverse Event Reporting Description	Postoperative Dizziness, Nausea and Vomiting (PONV): All these symptoms were asked altogether to the patients and assessed only as positive or negative
Arm/Group Title	Single ISB (SISB) Group		Continuous ISB (CISB) Group		General Anesthesia (GA) Group
Arm/Group Description	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.		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.		Patients in this group received general anesthesia (GA)
All Cause Mortality
	Single ISB (SISB) Group		Continuous ISB (CISB) Group		General Anesthesia (GA) Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Single ISB (SISB) Group		Continuous ISB (CISB) Group		General Anesthesia (GA) Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/23 (21.7%)		0/20 (0%)		2/20 (10%)
Gastrointestinal disorders
PONV	5/23 (21.7%)	5	0/20 (0%)	0	2/20 (10%)	2
Other (Not Including Serious) Adverse Events
	Single ISB (SISB) Group		Continuous ISB (CISB) Group		General Anesthesia (GA) Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/20 (0%)		0/20 (0%)

Limitations/Caveats

1. It was difficult to keep three different groups blinded. 2. The resting and mobilization highest/worst NRS pain scores were ignored and only the highest pain scores of the postoperative days 1, 2, 3, and 7 were recorded.

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.