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Optimal Location of Local Anesthetic Injection for Ultrasound Guided Interscalene Block

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ClinicalTrials.gov Identifier: NCT01877330
Recruitment Status : Completed
First Posted : June 13, 2013
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
This is a prospective randomized clinical trial to determine where is the optimal location for local anesthetic injection for ultrasound guided interscalene nerve blocks. The investigators are investigating if local anesthetic deposited between the nerve roots is more effective than local anesthetic deposited in the interscalene groove.

Condition or disease Intervention/treatment Phase
Shoulder Arthroscopy Ultrasound-guided Interscalene Nerve Block Procedure: Interscalene block for shoulder arthroscopy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intraplexus vs Extraplexus Injection of Local Anesthetic for Interscalene Block for Patients Undergoing Arthroscopic Shoulder Surgery
Study Start Date : January 2013
Actual Primary Completion Date : March 2016
Actual Study Completion Date : April 2016

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Arm Intervention/treatment
Active Comparator: Injection in interscalene groove
Patients undergoing shoulder arthroscopy will have an interscalene nerve block by injection of ropivacaine in the interscalene groove anterior and posterior to the brachial plexus nerves.
Procedure: Interscalene block for shoulder arthroscopy
Active Comparator: Injection between nerve roots
Patients undergoing shoulder arthroscopy will have an interscalene nerve block by injection of ropivacaine in the interscalene groove inbetween the C5 and C6 nerve roots.
Procedure: Interscalene block for shoulder arthroscopy



Primary Outcome Measures :
  1. Onset of motor blockade [ Time Frame: 1 hour from time of injection ]
    Time to loss of shoulder abduction.


Secondary Outcome Measures :
  1. Patient Satisfaction Score [ Time Frame: 24 hours ]
  2. Opioid consumption [ Time Frame: 24 hours ]
    Opioid consumption - perioperative and post discharge

  3. Quality of Nerve block [ Time Frame: 24 hours ]
    onset of sensory block

  4. Incidence of post-operative nausea/vomiting [ Time Frame: 24 hours ]
  5. Duration of nerve block [ Time Frame: 24 hours ]
    Duration of analgesia from nerve block

  6. Number of needle passes [ Time Frame: 1 hour ]
  7. Number of paresthesias [ Time Frame: 1 hour ]
    number of paresthesia experience during nerve block

  8. Residual paresthesia [ Time Frame: 24 hour ]
    incidence of residual paresthesias



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

ASA I-II patients who are 18 years and older and who are scheduled for shoulder arthroscopy are eligible for enrollment provided they do not have any of the following exclusion criteria.

Exclusion Criteria:

  • chronic pain
  • high preoperative opioid requirement
  • age < 18 years old
  • non-English speaking
  • contraindication to regional anesthesia (allergy to local anesthetics, coagulopathy, severe thrombocytopenia, pre-existing neuropathy in operative limb, infection at puncture site)
  • need for postoperative nerve function monitoring
  • patient refusal
  • dementia
  • pulmonary disease or low baseline oxygen saturation

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): NCT01877330


Locations
United States, California
UCSF Orthopedic Institute
San Francisco, California, United States, 94158
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Pedram Aleshi, MD University of California, San Francisco
Principal Investigator: Monica W Harbell, MD University of California, San Francisco

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01877330     History of Changes
Other Study ID Numbers: ISNB001
First Posted: June 13, 2013    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: April 2016

Keywords provided by University of California, San Francisco:
shoulder arthroscopy
ultrasound guided nerve block
interscalene nerve block

Additional relevant MeSH terms:
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents