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Predictors of Postoperative Pain

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ClinicalTrials.gov Identifier: NCT01449318
Recruitment Status : Completed
First Posted : October 10, 2011
Last Update Posted : May 16, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of the study is to prove that pain scores generated from painful stimuli applied preoperatively may help identify the inter-individual variability in pain perception.

Condition or disease Intervention/treatment
Postoperative Pain Device: Thermal Sensory Analyzer (Senselab)

Detailed Description:
Psychological factors and experimental pain models such as as electrical, pressure, heat, or cold stimuli have been identified as predictors of pain intensity and opioid consumption postoperatively. This study will investigate, in addition to the factors described above, the ability of pain scores generated from painful stimuli postoperatively in predicting postoperative pain.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Predictors of Postoperative Pain Following Abdominal Hysterectomy
Study Start Date : July 2012
Primary Completion Date : March 2014
Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: Patients undergoing hysterectomy Device: Thermal Sensory Analyzer (Senselab)

Thermal stimuli will be administered to the ventral surface of the dominant forearm and then to the lower abdomen (surgical site)using the Thermal Sensory Analyser. Each thermal testing trial will be separated by approximately 2 min and at a separate site.

To measure the thermal pain threshold temperature, The thermode will be applied to the ventral surface of the dominant forearm and the temperature will be increased at 1°C/s from 35 to 50°C.

To measure the Suprathreshold Thermal Pain Intensity and unpleasantness, Stimulus responses for noxious heat stimuli will be performed by applying phasic heat stimuli at 8 different temperatures (35, 43, 44, 45, 46, 47, 48, and 49°C).

Other Name: Modular Sensory Analyzer, Senselab


Outcome Measures

Primary Outcome Measures :
  1. pain scores from IV insertion [ Time Frame: 15 minutes prior to induction ]

Secondary Outcome Measures :
  1. Anxiety [ Time Frame: 24 to 48 hours before surgery ]
  2. Pain from thermal stimuli [ Time Frame: 24 to 48 hours before surgery ]
    Pain from thermal stimuli will be measure at two sites: site of surgery and at the forearm.

  3. Suprathreshold Thermal pain intensity [ Time Frame: 24 to 48 hours before surgery ]
    Suprathreshold Thermal pain intensity will be recorded at two site: site of surgery and forearm

  4. suprathreshold thermal unpleasantness intensity [ Time Frame: 24 to 48 hours before surgery ]
  5. Expectation about pain [ Time Frame: 24 to 48 hours before surgery ]
  6. postoperative pain [ Time Frame: within 1-2 hours after arrival to recovery room; and at 12 hours, 24 hours, 36 hours and 48 hours after surgery ]
    Postoperative pain will be measured upon arrival to the Post Anesthesia Care Unit (PACU)before morphine consumption and after morphine consumption, at rest and at movement.

  7. Morphine consumption [ Time Frame: within 1-2 hours after arrival to recovery room; and at 12 hours, 24 hours, 36 hours and 48 hours after surgery ]

Eligibility Criteria

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Ages Eligible for Study:   35 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients undergoing abdominal hysterectomy through a pfannenstiel incision
  • American Society of Anesthesiologists (ASA)Class I-III

Exclusion Criteria:

  • Patients with a history of psychiatric disease
  • Diabetic or alcoholic patients who may have impaired sensation due peripheral neuropathies
  • chronic opioid or nonsteroidal antiinflammatory drug use
  • chronic pain conditions
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01449318


Locations
Lebanon
American Unversity of Beirut Medical Center
Beirut, Lebanon
AUBMC
Beirut, Lebanon
Sponsors and Collaborators
American University of Beirut Medical Center
Investigators
Principal Investigator: Marie T Aouad, MD American University of Beirut Medical Center
More Information

Responsible Party: American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT01449318     History of Changes
Other Study ID Numbers: ANES.MA.13
AUBMC ( Other Identifier: AUBMC )
First Posted: October 10, 2011    Key Record Dates
Last Update Posted: May 16, 2014
Last Verified: September 2013

Keywords provided by American University of Beirut Medical Center:
Pain
quantitative sensory testing

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms