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Clinical Trials/NCT01877330
NCT01877330CompletedNot Applicable

Intraplexus vs Extraplexus Injection of Local Anesthetic for Interscalene Block for Patients Undergoing Arthroscopic Shoulder Surgery

University of California, San Francisco2 sites in 1 country208 target enrollmentStarted: January 2013Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
208
Locations
2
Primary Endpoint
Onset of motor blockade
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • •pulmonary disease or low baseline oxygen saturation

Outcomes

Primary Outcomes

Onset of motor blockade

Time Frame: 1 hour from time of injection

Time to loss of shoulder abduction.

Secondary Outcomes

  • Number of needle passes(1 hour)
  • Patient Satisfaction Score(24 hours)
  • Opioid consumption(24 hours)
  • Quality of Nerve block(24 hours)
  • Incidence of post-operative nausea/vomiting(24 hours)
  • Duration of nerve block(24 hours)
  • Number of paresthesias(1 hour)
  • Residual paresthesia(24 hour)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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