search
Back to results

Predictors of Postoperative Pain

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
Thermal Sensory Analyzer (Senselab)
Sponsored by
American University of Beirut Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain focused on measuring Pain, quantitative sensory testing

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • American Unversity of Beirut Medical Center
  • AUBMC

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

Patients undergoing hysterectomy

Arm Description

Outcomes

Primary Outcome Measures

pain scores from IV insertion

Secondary Outcome Measures

Anxiety
Pain from thermal stimuli
Pain from thermal stimuli will be measure at two sites: site of surgery and at the forearm.
Suprathreshold Thermal pain intensity
Suprathreshold Thermal pain intensity will be recorded at two site: site of surgery and forearm
suprathreshold thermal unpleasantness intensity
Expectation about pain
postoperative pain
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

Full Information

First Posted
September 28, 2011
Last Updated
May 15, 2014
Sponsor
American University of Beirut Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01449318
Brief Title
Predictors of Postoperative Pain
Official Title
Predictors of Postoperative Pain Following Abdominal Hysterectomy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
American University of Beirut Medical Center

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Pain, quantitative sensory testing

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients undergoing hysterectomy
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Thermal Sensory Analyzer (Senselab)
Other Intervention Name(s)
Modular Sensory Analyzer, Senselab
Intervention Description
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).
Primary Outcome Measure Information:
Title
pain scores from IV insertion
Time Frame
15 minutes prior to induction
Secondary Outcome Measure Information:
Title
Anxiety
Time Frame
24 to 48 hours before surgery
Title
Pain from thermal stimuli
Description
Pain from thermal stimuli will be measure at two sites: site of surgery and at the forearm.
Time Frame
24 to 48 hours before surgery
Title
Suprathreshold Thermal pain intensity
Description
Suprathreshold Thermal pain intensity will be recorded at two site: site of surgery and forearm
Time Frame
24 to 48 hours before surgery
Title
suprathreshold thermal unpleasantness intensity
Time Frame
24 to 48 hours before surgery
Title
Expectation about pain
Time Frame
24 to 48 hours before surgery
Title
postoperative pain
Description
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.
Time Frame
within 1-2 hours after arrival to recovery room; and at 12 hours, 24 hours, 36 hours and 48 hours after surgery
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie T Aouad, MD
Organizational Affiliation
American University of Beirut Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
American Unversity of Beirut Medical Center
City
Beirut
Country
Lebanon
Facility Name
AUBMC
City
Beirut
Country
Lebanon

12. IPD Sharing Statement

Learn more about this trial

Predictors of Postoperative Pain

We'll reach out to this number within 24 hrs