Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Predictors of Postoperative Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
American University of Beirut Medical Center
ClinicalTrials.gov Identifier:
NCT01449318
First received: September 28, 2011
Last updated: May 15, 2014
Last verified: September 2013
  Purpose

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 Intervention
Postoperative Pain
Device: Thermal Sensory Analyzer (Senselab)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Predictors of Postoperative Pain Following Abdominal Hysterectomy

Resource links provided by NLM:


Further study details as provided by American University of Beirut Medical Center:

Primary Outcome Measures:
  • pain scores from IV insertion [ Time Frame: 15 minutes prior to induction ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anxiety [ Time Frame: 24 to 48 hours before surgery ] [ Designated as safety issue: No ]
  • Pain from thermal stimuli [ Time Frame: 24 to 48 hours before surgery ] [ Designated as safety issue: No ]
    Pain from thermal stimuli will be measure at two sites: site of surgery and at the forearm.

  • Suprathreshold Thermal pain intensity [ Time Frame: 24 to 48 hours before surgery ] [ Designated as safety issue: No ]
    Suprathreshold Thermal pain intensity will be recorded at two site: site of surgery and forearm

  • suprathreshold thermal unpleasantness intensity [ Time Frame: 24 to 48 hours before surgery ] [ Designated as safety issue: No ]
  • Expectation about pain [ Time Frame: 24 to 48 hours before surgery ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: July 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders 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
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: 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

No publications provided

Responsible Party: American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT01449318     History of Changes
Other Study ID Numbers: ANES.MA.13, AUBMC
Study First Received: September 28, 2011
Last Updated: May 15, 2014
Health Authority: Lebanon: Institutional Review Board

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

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014