Post Operative PainNCT06065683
Acute Postoperative Pain Prevalence and Intensity in the First 72 Hours
An observational study of Post Operative Pain, run by Wollo University at 1 site in Ethiopia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- surgery
- Type of treatment
- Surgery or procedure
- How many people
- 350 participants
- Where
- 1 siteEthiopia
- Study dates
- 1 Sep 2022to 30 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Postoperative Pain Prevalence and Intensity in the First 72 Hours in Dessie Referral Hospital, Ethiopia: a Prospective Single-center Cohort Study
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.
Read the 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.
- Conditions
- Post Operative Pain
- Being tested
- surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryProcedure or surgery
Surgical procedures performed in the study period
| Study group | Role | What they receive |
|---|---|---|
| T2 hour | Not described Receives: Procedure: surgery | |
| T12 hour | Not described Receives: Procedure: surgery | |
| T24 hour | Not described Receives: Procedure: surgery | |
| T48 hour | Not described Receives: Procedure: surgery | |
| T72 hour | Not described Receives: Procedure: surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of postoperative pain in the first 72 hrs
prevalence of postoperative pain , at 2nd, 4th, 8th, 12th, 24th, 48th and 72nd hr.
Measured: 72 hours
Secondary outcomes (1)
Intensity of postoperative pain in the first 72 hrs.
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.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start1 Sep 2022
- Primary completion30 Jan 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wollo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Timerga, Wollo University
- Investigators
- Sara Timerga, Principal investigator, Wollo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065683
- Sponsor's protocol ID
- Acute pain
- Status last verified
- Oct 2023
- First submitted
- 1 Aug 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Postoperative Pain Prevalence and Intensity in the First 72 Hours in Dessie Referral Hospital, Ethiopia: a Prospective Single-center Cohort Study
- ClinicalTrials.gov ID
- NCT06065683
- Acronym / sponsor ID
- Acute pain
- Conditions
- Post Operative Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Wollo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 4 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| T2 hour | – | Procedure: surgery |
| T12 hour | – | Procedure: surgery |
| T24 hour | – | Procedure: surgery |
| T48 hour | – | Procedure: surgery |
| T72 hour | – | Procedure: surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgerySurgical procedures performed in the study period | Procedure or surgery | T12 hour, T2 hour, T24 hour, T48 hour, T72 hour |
Primary outcome
Prevalence of postoperative pain in the first 72 hrs
Time frame: 72 hours
prevalence of postoperative pain , at 2nd, 4th, 8th, 12th, 24th, 48th and 72nd hr.
1 secondary outcome
Intensity of postoperative pain in the first 72 hrs.
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
Related trials for Post Operative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Timerga principal investigator
Wollo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Operative Pain, run by Wollo University at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of postoperative pain in the first 72 hrs (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.