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

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ClinicalTrials.gov Identifier: NCT01881776
Recruitment Status : Completed
First Posted : June 20, 2013
Results First Posted : June 4, 2014
Last Update Posted : June 4, 2014
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center

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.

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Study Type : Interventional  (Clinical Trial)
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 : August 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

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)



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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01881776


Locations
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United States, New York
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
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Principal Investigator: Admir Hadzic, MD,PhD,Prof St. Luke's-Roosevelt Hospital Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT01881776    
Other Study ID Numbers: 10142
First Posted: June 20, 2013    Key Record Dates
Results First Posted: June 4, 2014
Last Update Posted: June 4, 2014
Last Verified: July 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:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs