Experimental Pain Reporting Accuracy and Clinical Post-operative Pain

NCT03854669 | Unknown

• 1 other identifier: CMC-18-0082-CTIL
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Pain is a subjective experience that differs in intensity from one person to another. Appropriate medical care relies on an accurate assessment of the patients' condition. However, when it comes to subjective assessment, accurate assessment is a challenge. The most common tools used to estimate pain intensity depend on patient pain reports on a numerical pain scale (NPS) or a similar scales. Although these tools are widely used, there is a tendency to ignore the fact that the reliability and accuracy of pain reports are strongly influenced not only by the measuring instrument, but also by the person who uses it. A method has recently been developed to assess the accuracy of pain reports, and in a series of studies it has been found that the more accurate a person is in pain reports in response to stimulation,the smaller his placebo effect is .The aim of the study is to investigate whether assessing the accuracy of a person's pain reports can predict who will experience intensified post-operative pain and post-operative analgesic medications intake.The study will include 40 patients undergoing elective head \& neck surgery. The study will be conducted prospectively and will include one pre-operative meeting to assess the accuracy of pain reports using the Focused Analgesia Selection Test (FAST). Patients will also complete pain-related psychological questionnaires during the session. In addition, post-operative pain measurements (NPS), and the use of pain relieving drugs (SOS) will be taken until release.

Conditions

Surgical Procedure, Unspecified; Pain, Postoperative; Ear, Nose, and Throat (ENT) Disease

Keywords

Acute post-operative pain; Clinical pain variability; Experimental pain variability; FAST; pain reporting accuracy

Outcome Measures

Primary Outcomes (2)

• Change in acute post-operative pain throughout the hospitalization period

  Subjects will be asked to report their pain on numerical pain scale (NPS) ranging from 0, denoting "no pain", to 10, denoting "the worst pain imaginable".

  From post-surgery recovery until discharge at specific time points: pain report (NPS) at the time of analgesic medication consumption, an hour after administration of the drug, in addition to regular monitoring of every 6 hours during hospitalization.

• Amount of analgesic drugs consumption I

  Quantification of the amount of analgesic drugs consumption will be performed by counting the number of times an SOS drug has been given. The SOS medications (beyond analgesic protocol) include Optalgin PO / Acamol IV / Oxycodone PO/ tramal IV.

  From post-surgery recovery until discharge (24-48 hours after surgery)

Secondary Outcomes (2)

• Amount of analgesic drugs consumption II

  From post-surgery recovery until discharge (24-48 hours after surgery)

• Amount of analgesic drugs consumption III

  From post-surgery recovery until discharge (24-48 hours after surgery)

Study Arms (1)

Assessing pain reporting accuracy

EXPERIMENTAL

Subjects will undergo pre-operative evaluation of their pain reporting accuracy ability in order to assess its relation to post-operative acute pain and analgesic consumption

Device: pain reporting accuracy

Interventions

pain reporting accuracy DEVICE

pain reporting accuracy will be assessed by the Focused Analgesia Selection Task (FAST) procedure. The FAST is based on recording a subject's pain reports in response to repeated administration of thermal noxious stimuli of various intensities, applied on the non-dominant arm with the Medoc® Thermal Sensory Analyzer II. The subjects will receive 1 of 7 designated temperatures (44°C, 45°C, 46°C, 47°C, 48°C, 49°C, and 50°C), each presented 7 times in a random block-ordered design (49 stimuli in total).

Assessing pain reporting accuracy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18
• Candidates to Head \& Neck elective surgery

You may not qualify if:

• Presence of diagnosed psychiatric disorders, cognitive and /or neurological deficits;
• Use of analgesic, anti-depressants or anti-anxiolytics medications on a regular basis (except for oral contraceptives);
• Pregnancy.
• Inability to give informed consent, communicate, and understand the purpose and instructions of this study.

Sponsors & Collaborators

• Carmel Medical Center: lead
• University of Haifa: collaborator

Study Sites (1)

Carmel Medical Center

Haifa, 3436212, Israel

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Disease

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Tal Honigman, MD

CONTACT

972-(0)4-8250433; TalHo@clalit.org.il

Liat Honigman, PhD

CONTACT

972-(0)4-6146214; taliathonigman@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: February 26, 2019
• Study Start: September 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: January 28, 2020

Record last verified: 2020-01

Locations

IL (1)