Electrical Skin Conductance Monitoring as an Assessment of Post Operative Pain Scores

NCT02408263 | Completed Results

• 1 other identifier: 10106
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Pain has been defined as a subjective experience. Various pain assessment tools, (such as NRS) have been developed and validated to objectively monitor and treat pain. There are certain patient populations, in whom, the current pain assessment tools cannot be used effectively due to communication problems such as cognitively impaired patients. In the US, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has made it mandatory to monitor and treat pain. In the absence of reliable pain assessment tools that would objectively measure pain, there is also risk of under treatment and overtreatment of pain that may lead to negative outcomes. Therefore, a monitor that is able to predict pain levels objectively, will help to achieve above goals. The investigators are using Skin Conductance Algesimeter (SCA) to measure pain by analyzing changes in skin conductance.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (2)

• Numeric Pain Rating Scale

  Numeric Pain Rating Scale, 0 (no pain) to 10 (worst pain)

  Baseline, Postoperative day 1, Postoperative Day 2

• Skin Conductance Response

  A skin conductance response is defined as a minimum followed by a maximum in conductance values micro Siemens (mS).

  Baseline, Postoperative day 1, Postoperative day 2

Secondary Outcomes (1)

• Nausea

  Baseline, Postoperative day 1, Postoperative day 2

Study Arms (1)

Total Hip Replacement (THR) and Total Knee Replacement (TKR)

25 patients receiving a THR and 25 patients receiving aTKR. The investigators are using Skin Conductance Algesimeter (SCA) to measure pain by analyzing changes in skin conductance.

Procedure: Total Hip Replacement (THR) and Total Knee Replacement (TKR)

Interventions

Total Hip Replacement (THR) and Total Knee Replacement (TKR) PROCEDURE

Total Hip Replacement is a surgical procedure where the cartilage and bone of the hip joint is replaced with artificial materials. Total Knee Replacement involves replacement of all three compartments of the knee the medial, the lateral and patellofemoral compartment.

Total Hip Replacement (THR) and Total Knee Replacement (TKR)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing surgery for unilateral Total Hip Replacement and Total Knee Replacement.

You may qualify if:

• 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 Motor Activity Assessment Scale (MAAS) Score of 3 and 4

You may not qualify if:

• Age \<18, \>85
• History of chronic pain as defined by use of long acting opioid medication \> 6 months duration.
• MAAS Score of \<3 and \>4.
• Anticholinergic agent use
• Patients with the following conditions:
• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead
• Oslo University Hospital: collaborator
• Weill Medical College of Cornell University: collaborator

Related Publications (3)

• Devlin JW, Boleski G, Mlynarek M, Nerenz DR, Peterson E, Jankowski M, Horst HM, Zarowitz BJ. Motor Activity Assessment Scale: a valid and reliable sedation scale for use with mechanically ventilated patients in an adult surgical intensive care unit. Crit Care Med. 1999 Jul;27(7):1271-5. doi: 10.1097/00003246-199907000-00008.

  PMID: 10446819 BACKGROUND

• Kunimoto M, Kirno K, Elam M, Wallin BG. Neuroeffector characteristics of sweat glands in the human hand activated by regular neural stimuli. J Physiol. 1991 Oct;442:391-411. doi: 10.1113/jphysiol.1991.sp018799.

  PMID: 1798033 BACKGROUND

• Storm H, Shafiei M, Myre K, Raeder J. Palmar skin conductance compared to a developed stress score and to noxious and awakening stimuli on patients in anaesthesia. Acta Anaesthesiol Scand. 2005 Jul;49(6):798-803. doi: 10.1111/j.1399-6576.2005.00665.x.

  PMID: 15954962 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Arthroplasty, Replacement, Hip; Threonine; Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation; Amino Acids, Essential; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Neutral

Results Point of Contact

• Title: Dr. Gungor
• Organization: HSS

GungorS@hss.edu

212.606.1206

Study Officials

• Semih Gungor, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2015
• First Posted: April 3, 2015
• Study Start: November 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: August 28, 2019
• Results First Posted: December 18, 2017

Record last verified: 2019-08