Biobehavioral Recovery From Surgery and Anesthesia

NCT00176696 | Terminated

• 1 other identifier: 0120050013
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Reducing postoperative pain leads to increased patient comfort and facilitates speedy recovery and discharge from the hospital following surgery. The focus of controlling postoperative pain has gradually shifted from postoperative management to intraoperative management. The investigators believe that this study is a unique opportunity to assess the adequacy of intraoperative analgesia, allowing for immediate administration of the appropriate opioid analgesics. The purpose of this research is to bring to light the applicability of facial electromyography as an intraoperative solution to postoperative pain management.

Conditions

Pain, Postoperative

Keywords

general anesthesia; pain; depth of anesthesia

Outcome Measures

Primary Outcomes (1)

• detection of pain during general anesthesia

  after induction of anesthesia

Secondary Outcomes (1)

• Visual analogue scale for first two days post anesthesia

  2 post op days

Interventions

Use of FACE monitor and BIS monitor DEVICE

Face monitor records facial muscle activity

Also known as: BIS (Bispectral Score)determines the depth of anesthesia

Eligibility Criteria

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

Study Population

subjects undergoing surgery

You may qualify if:

• Subjects 18-65 years of age
• Subjects who are English speaking
• Subjects undergoing surgery in the supine position
• Subjects who are undergoing a procedure where the surgical incision is expected to be at least 4 inches
• Subjects who are undergoing a surgical procedure below the level of their arms.
• Female subjects who have a negative Sure-Vue pregnancy test.
• Subjects who are undergoing surgery under general anesthesia.

You may not qualify if:

• If the scheduled surgery involves the head, neck or arms.
• Subjects who have a history of chronic pain
• Subjects who have cognitive disabilities secondary to medical, chemical and genetic causes.
• Subjects who have peripheral vascular disease of the arms.
• Subjects who have carpal tunnel syndrome.
• Subjects who have psychiatric, substance abuse and cognitive impairments
• Subjects who have had a stroke which has affected function of the upper extremities
• Subjects who have had a mastectomy or other type of surgery which may have affected the lymph nodes of the arms
• Subjects who do not have a telephone
• Subjects who are having surgery under nerve block or regional anesthesia
• Subjects who are pregnant
• Subjects who have an electrical source, i.e. pacemaker or defibrillator

Sponsors & Collaborators

• University of Medicine and Dentistry of New Jersey: lead

MeSH Terms

Conditions

Pain, Postoperative; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Henry L. Bennett, PhD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: August 1, 2005
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: October 6, 2016

Record last verified: 2008-06

Data Sharing

• IPD Sharing: Will not share