Predictors of Postoperative Pain

Predictors of Postoperative Pain Following Abdominal Hysterectomy

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • AUBMC
  • Beirut, Lebanon
    • American Unversity of Beirut Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Modular Sensory Analyzer, Senselab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
pain scores from IV insertion	15 minutes prior to induction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety		24 to 48 hours before surgery
Pain from thermal stimuli	Pain from thermal stimuli will be measure at two sites: site of surgery and at the forearm.	24 to 48 hours before surgery
Suprathreshold Thermal pain intensity	Suprathreshold Thermal pain intensity will be recorded at two site: site of surgery and forearm	24 to 48 hours before surgery
suprathreshold thermal unpleasantness intensity		24 to 48 hours before surgery
Expectation about pain		24 to 48 hours before surgery
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.	within 1-2 hours after arrival to recovery room; and at 12 hours, 24 hours, 36 hours and 48 hours after surgery
Morphine consumption		within 1-2 hours after arrival to recovery room; and at 12 hours, 24 hours, 36 hours and 48 hours after surgery

Collaborators and Investigators

• Sponsor: American University of Beirut Medical Center
• Investigators: Principal Investigator: Marie T Aouad, MD, American University of Beirut Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: September 28, 2011
• First Submitted That Met QC Criteria: October 7, 2011
• First Posted (Estimate): October 10, 2011

Study Record Updates

• Last Update Posted (Estimate): May 16, 2014
• Last Update Submitted That Met QC Criteria: May 15, 2014
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Pain; quantitative sensory testing
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: ANES.MA.13; AUBMC (Other Identifier: AUBMC)