Improvement in Postoperative Pain Outcomes

Sponsor
King Saud University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05624502
Collaborator
(none)
1,000
1
72
13.9

Study Details

Study Description

Brief Summary

This is an observational study project aims at improving postoperative pain outcomes by evaluating the current status of postoperative pain managements in the institution. Then the investigators will compare the results by internal and external benchmarking. Then they will suggest recommendations to improve the current situation of postoperative pain management.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    At least half of the patients suffer from moderate to severe post-operative pain. The price of poorly managed pain is high: pain impedes recovery, causes suffering and prolongs the hospital stay. PAIN OUT provides tools for measurement, feedback and benchmarking of pain treatment quality in order to improve patient care. A research project that aims at improving postoperative pain treatment outcomes by evaluating the current status of postoperative pain managements in our institution. Then the investigators compare the results by internal and external benchmarking. Then suggest recommendations to improve the current situation of postoperative pain management.

    parameters include" Patient's data Pain assessments by using the visual analogue score of 11 point (from "0" no pain - "10" worst pain) will be evaluated as the following: Worst pain since surgery, Least pain since surgery, Pain score at rest. Pain score during movements in bed, Pain score during deep breathing and coughing, How often the severe pain since surgery (%), Does the pain interfere with sleeping pattern, and the side effects.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Mprovement in Postoperative Pain Outcome: Pain Registry
    Actual Study Start Date :
    Jan 1, 2019
    Anticipated Primary Completion Date :
    Oct 31, 2024
    Anticipated Study Completion Date :
    Dec 31, 2024

    Outcome Measures

    Primary Outcome Measures

    1. postoperative pain scores [first 3 days postoperative]

      using visual analogue scale (VAS) for pain assessment of 11 points (from "0" no pain to "10" worst pain

    2. time in severe pain [during the first 24 hours]

      duration of time spent in severe pain after surgery

    3. dynamic and static pain [during the first 24 hours]

      Pain scores or rest and during movements

    Secondary Outcome Measures

    1. worst and least pain [during the first 24 hours]

      The highest and lowest pain scores during the first 24 hours

    2. time to first request of analgesia [during the first 24 hours]

      the time from the recovery to the first request of postoperative analgesia

    3. total analgesic consumption [during the first 24 hours]

      total consumption of opioids / non-opioids during the first 24 hours

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Postoperative patients during the first 24 hours of surgery (day 1)

    • Male and Females

    • Adults

    Exclusion Criteria:
    • Patient refusal

    • Drug abusers and addicts

    • Major significant systemic diseases

    • Language barriers

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Salah N. El-Tallawy Riyadh Saudi Arabia 7805

    Sponsors and Collaborators

    • King Saud University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    SALAH EL-TALLAWY, Professor and Consultant - Anesthesia and Pain Management, King Saud University
    ClinicalTrials.gov Identifier:
    NCT05624502
    Other Study ID Numbers:
    • 18/0443/IRB
    First Posted:
    Nov 22, 2022
    Last Update Posted:
    Dec 27, 2022
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by SALAH EL-TALLAWY, Professor and Consultant - Anesthesia and Pain Management, King Saud University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 27, 2022