Predictors of Postoperative Pain

Postoperative Pain Clinical Trial

Official title:

Predictors of Postoperative Pain Following Abdominal Hysterectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01449318
• Other study ID #: ANES.MA.13
• Secondary ID: AUBMC
• Status: Completed
• Phase: N/A
• First received: September 28, 2011
• Last updated: May 15, 2014
• Start date: July 2012
• Est. completion date: March 2014

Study information

• Verified date: September 2013
• Source: American University of Beirut Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Lebanon: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 65 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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).

Locations

Country	Name	City	State
Lebanon	American Unversity of Beirut Medical Center	Beirut
Lebanon	AUBMC	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
American University of Beirut Medical Center

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain scores from IV insertion		15 minutes prior to induction	No
Secondary	Anxiety		24 to 48 hours before surgery	No
Secondary	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	No
Secondary	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	No
Secondary	suprathreshold thermal unpleasantness intensity		24 to 48 hours before surgery	No
Secondary	Expectation about pain		24 to 48 hours before surgery	No
Secondary	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	No
Secondary	Morphine consumption		within 1-2 hours after arrival to recovery room; and at 12 hours, 24 hours, 36 hours and 48 hours after surgery	No