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Completed

NCT Number: NCT01449318

Predictors of Postoperative Pain

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.

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Key information

Age range

35 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

AUBMC, Beirut, Lebanon

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thermal Sensory Analyzer (Senselab)

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).

Other names: Modular Sensory Analyzer, Senselab

Primary outcomes

  1. pain scores from IV insertion

    Time frame: 15 minutes prior to induction

Secondary outcomes

  1. Anxiety

    Time frame: 24 to 48 hours before surgery

  2. Pain from thermal stimuli

    Time frame: 24 to 48 hours before surgery

    Pain from thermal stimuli will be measure at two sites: site of surgery and at the forearm.

  3. Suprathreshold Thermal pain intensity

    Time frame: 24 to 48 hours before surgery

    Suprathreshold Thermal pain intensity will be recorded at two site: site of surgery and forearm

  4. suprathreshold thermal unpleasantness intensity

    Time frame: 24 to 48 hours before surgery

  5. Expectation about pain

    Time frame: 24 to 48 hours before surgery

  6. 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

    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.

  7. 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

Sponsors and collaborators

Lead sponsor

American University of Beirut Medical Center

Other

Registry information

Official study title

Predictors of Postoperative Pain Following Abdominal Hysterectomy

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 10, 2011
Registry last updated
May 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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