Comparison of Bacteriostatic Saline to Buffered Lidocaine for Ultrasound Guided Hip Joint Injection Local Anesthesia

NCT02209272 | Completed Phase 4 Results

• 1 other identifier: 14-002622
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare infiltration pain and anesthetic efficacy between lidocaine and Bacteriostatic saline (BS) for ultrasound (US) guided intraarticular hip injections.

Conditions

Hip Pain

Outcome Measures

Primary Outcomes (1)

• VAS for Pain Score During Local Anesthesia Infiltration

  The Visual Analog Scale (VAS) for Pain is a validated tool used to measure pain. A 100mm horizontal line anchored by "no pain" (score of 0) and "pain as bad as it could be" (score of 100).

  baseline to 5-10 minutes later -- immediately after local anesthetic injection administration

Secondary Outcomes (2)

• VAS for Pain Score During Subsequent Hip Joint Injection (Local Anesthetic Efficacy)

  baseline to 5-10 minutes later -- immediately after hip joint injection

• Anesthetic Infiltration Duration

  baseline

Study Arms (2)

bacteriostatic saline

EXPERIMENTAL

for ultrasound guided hip joint injection local anesthesia

Drug: bacteriostatic saline

buffered lidocaine

ACTIVE COMPARATOR

for ultrasound guided hip joint injection local anesthesia

Drug: buffered lidocaine

Interventions

bacteriostatic saline DRUG

Also known as: 0.9% benzyl alcohol

bacteriostatic saline

buffered lidocaine DRUG

Also known as: 1% lidocaine combined (9:1) with sodium bicarbonate

buffered lidocaine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18-75 years
• referred for US-guided intraarticular hip injections in the Mayo Clinic Sports Medicine Center, Physical Medicine \& Rehabilitation Clinic, or Musculoskeletal Clinic

You may not qualify if:

• chronic opioid use
• opioid use on day of procedure
• history of fibromyalgia or other diffuse chronic pain syndrome
• pain behavior during the clinical encounter as judged by the injectionist
• anesthetic administration time outside the designated 5-15 second time frame

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Benzyl Alcohol; Sodium Bicarbonate

Intervention Hierarchy (Ancestors)

Benzyl Alcohols; Alcohols; Organic Chemicals; Benzyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Jacob L. Sellon
• Organization: Mayo Clinic

sellon.jacob@mayo.edu

507-284-2608

Study Officials

• Jacob Sellon, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Physical Medicine and Rehabilitation, Sports Medicine Center

Study Record Dates

• First Submitted: July 31, 2014
• First Posted: August 5, 2014
• Study Start: August 1, 2014
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: April 11, 2019
• Results First Posted: April 2, 2019

Record last verified: 2019-04

Locations

US (1)