Improvement in Postoperative Pain Outcomes

December 22, 2022 updated by: SALAH EL-TALLAWY, King Saud University

Mprovement in Postoperative Pain Outcome: Pain Registry

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Acute postoperative pain patients after different surgical procedures

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain scores
Time Frame: first 3 days postoperative
using visual analogue scale (VAS) for pain assessment of 11 points (from "0" no pain to "10" worst pain
first 3 days postoperative
time in severe pain
Time Frame: during the first 24 hours
duration of time spent in severe pain after surgery
during the first 24 hours
dynamic and static pain
Time Frame: during the first 24 hours
Pain scores or rest and during movements
during the first 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
worst and least pain
Time Frame: during the first 24 hours
The highest and lowest pain scores during the first 24 hours
during the first 24 hours
time to first request of analgesia
Time Frame: during the first 24 hours
the time from the recovery to the first request of postoperative analgesia
during the first 24 hours
total analgesic consumption
Time Frame: during the first 24 hours
total consumption of opioids / non-opioids during the first 24 hours
during the first 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Saud University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Anticipated)

October 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

November 13, 2022

First Submitted That Met QC Criteria

November 14, 2022

First Posted (Actual)

November 22, 2022

Study Record Updates

Last Update Posted (Estimate)

December 26, 2022

Last Update Submitted That Met QC Criteria

December 22, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18/0443/IRB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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