Predictors of Postoperative Pain

NCT ID: NCT01449318

Last Updated: 2014-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2014-03-31

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Patients undergoing hysterectomy

Group Type: NO_INTERVENTION

Thermal Sensory Analyzer (Senselab)

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

Other Intervention Names

Modular Sensory Analyzer, Senselab

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

American University of Beirut Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie T Aouad, MD

Role: PRINCIPAL_INVESTIGATOR

American University of Beirut Medical Center

Locations

American Unversity of Beirut Medical Center

Beirut, , Lebanon

AUBMC

Beirut, , Lebanon

Countries

Lebanon

Other Identifiers

AUBMC

Identifier Type: OTHER

Identifier Source: secondary_id

ANES.MA.13

Identifier Type: -

Identifier Source: org_study_id