Research

Electrical Skin Conductance Monitoring as an Assessment of Post Operative Pain Scores: A Validation Study

IRB Number: 10106
(inactive trial)

Institutional Review Board, Hospital for Special Surgery

July 08, 2011

The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

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Principal Investigator

Semih Gungor, MD

Co-Investigators

Daniel Maalouf, MD
Karina Gritsenko, MD
Barbara Wukovits, RN
Heejung Bang, PhD
Hanne Storm, MD
Carey Ford
Valeria Buschiazzo
James Bae, MSc
Janet Cahill, PT, MS

Summary

We are recruiting a total of 250 patients.  This study is validating a device that could possibly objectify pain scores. This machine could lead to further groundbreaking research that could change the practice of pain management. This could be applied to all patients post-operatively. Follow up will be performed on POD 1 and 2.

Inclusion/Exclusion Criteria

Inclusion Criteria:

  • Patients undergoing unilateral THR and TKR who are between the ages of 18 and 85 regardless of the anesthesia and postoperative analgesia type.
    Patients participating in other studies may participate in this study as well
    Patients with MAAS Score of 3 and 4

Exclusion Criteria:

  • Patients Age <18, >85
  • Patients with history of chronic pain as defined by use of long acting opioid medication > 6 months duration.
  • Patients with MAAS Score of <3 and >4.
  • Patients with the following conditions:
     
    • Anticholinergic agent use
    •  Autonomic neuropathy
    •  Pacemaker/AICD
    •  Burn patients or patients with severe dermatologic conditions (as defined by skin conditions causing further pain to patients that actively has to be treated)
    •  Allergy to adhesive tape
    •  Communication barriers
    •  Bilateral Procedures
    •  Patient with diagnosis of : 
  • Dysautonomia
  •  Sympathetic dysfunction such as: 
    • Raynaud disease,  Buerger disease
    • Disorders of sweating such as:   Acquired idiopathic generalized anhidrosis

     

    Contact Information


    Valeria Buschiazzo
    buschiazzov@hss.edu
    212.774.7885

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