Medical Review: Hand Surgery After Local Block Versus Non-block

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ronald Wender, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT01110759
First received: April 23, 2010
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

In this study, the effects of local block vs non block will be assessed with respect to postoperative outcomes (such as pain score, and recovery profiles) in outpatients after hand surgery.


Condition
Carpal Tunnel Syndrome

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Retrospective Chart-review Study Involving Outpatients Who Underwent Hand Surgery With Local Anesthesia: Comparing Outcome With a Peripheral Nerve Block vs. Local Infiltration Alone

Resource links provided by NLM:


Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • postoperative pain [ Time Frame: hours to months ] [ Designated as safety issue: Yes ]
    1. Severity of the pain experienced before patient left the surgery center and after patient arrived at home
    2. Pain medication (amounts of opioids and non opioids pills) required

    d)Time to suffer pain at the surgical site (hand) (days, weeks, or months)



Secondary Outcome Measures:
  • Nausea [ Time Frame: days to weeks ] [ Designated as safety issue: Yes ]
    1. Severity of the nausea experienced by the patient.
    2. Medication required.
    3. Time to suffer nausea.

  • Vomiting [ Time Frame: dias to weeks ] [ Designated as safety issue: Yes ]
    1. Severity
    2. Medication required
    3. Time to suffer vomiting


Other Outcome Measures:
  • Outcomes [ Time Frame: days to weeks ] [ Designated as safety issue: Yes ]
    • Presence of any other problems: (e.g., headaches, dizziness, drowsiness, fatigue, constipation, difficulty voiding.)
    • Time taken to return to normal activities after surgery
    • Satisfaction with the pain management after surgery


Enrollment: 200
Study Start Date: August 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Under Local Infiltration
Under Peripheral Nerve Block

Detailed Description:

Analyzing medical records and through a telephone questionnaire, in a retrospective and prospective review respectively.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Outpatients undergoing hand surgery

Criteria

Inclusion Criteria:

  • 18-80 years old
  • Outpatients who underwent hand surgery under peripheral nerve block or local infiltration alone

Exclusion Criteria:

  • Patients who do not meet inclusion criteria
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01110759

Locations
United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Principal Investigator: Ronald H Wender, MD Cedars-Sinai Medical Center
  More Information

No publications provided

Responsible Party: Ronald Wender, Chairman, Department of Anesthesiology, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01110759     History of Changes
Other Study ID Numbers: Pro00019315
Study First Received: April 23, 2010
Last Updated: October 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
pain management
ambulatory surgery
opioid
local anesthesia
hand surgery
postoperative pain

Additional relevant MeSH terms:
Carpal Tunnel Syndrome
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries

ClinicalTrials.gov processed this record on July 23, 2014