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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

Tracking Information
First Submitted Date  ICMJE February 26, 2013
First Posted Date  ICMJE June 20, 2013
Results First Submitted Date  ICMJE July 11, 2013
Results First Posted Date  ICMJE June 4, 2014
Last Update Posted Date June 4, 2014
Study Start Date  ICMJE August 2011
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2014)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: June 19, 2013)
Postoperative highest NRS pain rating [ 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 (highest NRS pain rating)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2014)
  • 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).
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2013)
  • 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).
  • Analgesic consumption [ 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).
Current Other Pre-specified Outcome Measures
 (submitted: May 5, 2014)
  • 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
  • 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.
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures
 (submitted: June 19, 2013)
  • Fast-tracked PACU bypass rate [ Time Frame: Throughout the first postoperative week ]
    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
  • Length of PACU Stay [ Time Frame: Throughout the first postoperative week ]
    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 to Discharge Home [ Time Frame: Throughout the first postoperative week ]
    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.
  • Sleep duration [ Time Frame: Throughout the first postoperative week ]
    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.
  • Adverse effects [ Time Frame: Throughout the first postoperative week ]
 
Descriptive Information
Brief Title  ICMJE Continuous Interscalene Block Results in Superior Recovery Throughout the First Postoperative Week
Official Title  ICMJE Continuous Interscalene Block in Patients Having Outpatient Rotator Cuff Repair Surgery: a Prospective Randomized Trial
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Postoperative Pain
  • Adverse Effects
Intervention  ICMJE 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)
Study Arms  ICMJE
  • Active Comparator: Single ISB (SISB) group
    Patients in this group received single injection (SISB) interscalene brachial plexus block
    Intervention: Procedure: ISB
  • Active Comparator: Continuous ISB (CISB) group
    Patients in this group received continuous (CISB) interscalene brachial plexus block
    Intervention: Procedure: ISB
  • No Intervention: General anesthesia (GA) group
    Patients in this group received general anesthesia (GA)
Publications * Salviz EA, Xu D, Frulla A, Kwofie K, Shastri U, Chen J, Shariat AN, Littwin S, Lin E, Choi J, Hobeika P, Hadzic A. Continuous interscalene block in patients having outpatient rotator cuff repair surgery: a prospective randomized trial. Anesth Analg. 2013 Dec;117(6):1485-92. doi: 10.1213/01.ane.0000436607.40643.0a.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 19, 2013)
71
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01881776
Other Study ID Numbers  ICMJE 10142
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party St. Luke's-Roosevelt Hospital Center
Study Sponsor  ICMJE St. Luke's-Roosevelt Hospital Center
Collaborators  ICMJE Baxter Healthcare Corporation
Investigators  ICMJE
Principal Investigator: Admir Hadzic, MD,PhD,Prof St. Luke's-Roosevelt Hospital Center
PRS Account St. Luke's-Roosevelt Hospital Center
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP