Acute Postoperative Pain Prevalence and Intensity in the First 72 Hours

Sponsor
Wollo University (Other)
Overall Status
Completed
CT.gov ID
NCT06065683
Collaborator
(none)
350
1
10.9
32.1

Study Details

Study Description

Brief Summary

Postoperative pain is poorly studied in developing countries. Severe pain after surgery remains a major problem, occurring in 50% to 70% of the patients. Differences exist across countries. Despite numerous published studies, the degree of pain following many types of surgery in everyday clinical practice is unknown. To improve postoperative pain treatment and develop procedure-specific, optimized pain-treatment protocols, the prevalence and severity of postoperative pain must first be identified.

This study aimed to determine the incidence and intensity of acute postoperative pain, to identify populations associated with a higher risk in order to guide resource allocation, and to investigate whether inexpensive analgesic modalities are currently utilized maximally.

Condition or Disease Intervention/Treatment Phase
  • Procedure: surgery

Detailed Description

Postoperative pain management remains one of the major challenges in the care of surgical patients in many parts of the world. Despite improved care, studies show that postoperative pain continues to be inadequately treated and that patients still suffer moderate to severe pain after surgery. Despite an improved understanding of pain mechanisms, several risk factors, and advances in pain management strategies, postoperative pain continues to be a widespread and unresolved problem.

In Ethiopia, pain management is done in the traditional way, and pain control regimens vary from center to center and again from person to person in the same center due to a lack of pain management protocol. Overall pain management criteria used are not clear and sometimes decisions may be influenced by what is available in stock. Therefore, this research on the assessment of postoperative pain management provides information for clinicians to formulate protocols for the management of postoperative pain and for hospital managers in order to guide resource allocation to use limited resources efficiently and plan for optimum postoperative pain management.

In the study, the investigators used a numerical pain rating scale for pain immediately after surgery for the first 72 hours after surgery. The prevalence of mild, moderate, or severe pain and median pain scores were calculated. An evaluation will be performed at eight time points: at T2, T4, T8, T12, T24, T48, and T72. They consider 350 patients from all surgical wards. All surgical procedures were assigned to 5 well-defined groups. When a group contained less than 20 patients the data was excluded from the analysis.

Study Design

Study Type:
Observational
Actual Enrollment :
350 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Acute Postoperative Pain Prevalence and Intensity in the First 72 Hours in Dessie Referral Hospital, Ethiopia: a Prospective Single-center Cohort Study
Actual Study Start Date :
Sep 1, 2022
Actual Primary Completion Date :
Jan 30, 2023
Actual Study Completion Date :
Jul 30, 2023

Arms and Interventions

Arm Intervention/Treatment
T2 hour

Procedure: surgery
Surgical procedures performed in the study period

T12 hour

Procedure: surgery
Surgical procedures performed in the study period

T24 hour

Procedure: surgery
Surgical procedures performed in the study period

T48 hour

Procedure: surgery
Surgical procedures performed in the study period

T72 hour

Procedure: surgery
Surgical procedures performed in the study period

Outcome Measures

Primary Outcome Measures

  1. Prevalence of postoperative pain in the first 72 hrs [72 hours]

    prevalence of postoperative pain , at 2nd, 4th, 8th, 12th, 24th, 48th and 72nd hr.

Secondary Outcome Measures

  1. Intensity of postoperative pain in the first 72 hrs. [72 hours]

    The intensity of postoperative pain in the first 72 hours assessed with numeric rating scale. NRS 1-3 mild pain, 4-6 moderate pain, 7-10 severe pain.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Age ≥18 years old

  • Able to provide informed consent

  • Able to verbalize or indicate pain by using a traditional verbal scale such as the numeric rating scale at the 2nd hr. of Post anesthesia care unit arrival.

Exclusion Criteria:
  • Patients unable to self-report acute pain

  • Patients with a history of chronic pain, moderate to high acute pain previous to surgery.

  • Patients with a previous diagnosis of chronic cognitive impairment (Dementia, Alzheimer …)

  • Patients with a previous diagnosis of Neurologic impairment (paraplegia, q quadriplegia…)

  • The patients excluded from the study will be patients with mental and psychological problems.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Wollo Univeersity Dessie Ethiopia 1145

Sponsors and Collaborators

  • Wollo University

Investigators

  • Principal Investigator: Sara Timerga, Wollo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sara Timerga, Lecturer, Wollo University
ClinicalTrials.gov Identifier:
NCT06065683
Other Study ID Numbers:
  • Acute pain
First Posted:
Oct 4, 2023
Last Update Posted:
Oct 10, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 10, 2023