NCT06065683

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 1, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 4, 2023

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

5 months

First QC Date

August 1, 2023

Last Update Submit

October 7, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence of postoperative pain in the first 72 hrs

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

    72 hours

Secondary Outcomes (1)

  • Intensity of postoperative pain in the first 72 hrs.

    72 hours

Study Arms (5)

T2 hour

Procedure: surgery

T12 hour

Procedure: surgery

T24 hour

Procedure: surgery

T48 hour

Procedure: surgery

T72 hour

Procedure: surgery

Interventions

surgeryPROCEDURE

Surgical procedures performed in the study period

T12 hourT2 hourT24 hourT48 hourT72 hour

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All eligible patients who will be undergo elective major abdominal, gynecologic, urologic, obstetric and orthopedic surgeries at Dessie comprehensive specialized hospital in the course of study period

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wollo Univeersity

Dessie, 1145, Ethiopia

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Sara Timerga

    Wollo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

August 1, 2023

First Posted

October 4, 2023

Study Start

September 1, 2022

Primary Completion

January 30, 2023

Study Completion

July 30, 2023

Last Updated

October 10, 2023

Record last verified: 2023-10

Locations