Optimal Location of Local Anesthetic Injection for Ultrasound Guided Interscalene Block

Shoulder Arthroscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01877330
• Other study ID #: ISNB001
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: April 2016

Study information

• Verified date: March 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Arthroscopy
• Ultrasound-guided Interscalene Nerve Block

Intervention

Procedure:
• Interscalene block for shoulder arthroscopy

Locations

Country	Name	City	State
United States	UCSF Orthopedic Institute	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Onset of motor blockade	Time to loss of shoulder abduction.	1 hour from time of injection
Secondary	Patient Satisfaction Score		24 hours
Secondary	Opioid consumption	Opioid consumption - perioperative and post discharge	24 hours
Secondary	Quality of Nerve block	onset of sensory block	24 hours
Secondary	Incidence of post-operative nausea/vomiting		24 hours
Secondary	Duration of nerve block	Duration of analgesia from nerve block	24 hours
Secondary	Number of needle passes		1 hour
Secondary	Number of paresthesias	number of paresthesia experience during nerve block	1 hour
Secondary	Residual paresthesia	incidence of residual paresthesias	24 hour