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OpenTrials
Completed

NCT Number: NCT01877330

Optimal Location of Local Anesthetic Injection for Ultrasound Guided Interscalene Block

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSF Orthopedic Institute

San Francisco, California, 94158, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interscalene block for shoulder arthroscopy

Procedure

Primary outcomes

  1. Onset of motor blockade

    Time frame: 1 hour from time of injection

    Time to loss of shoulder abduction.

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 13, 2013
Registry last updated
Mar 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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