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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
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The goal of this observational study is to understand the approach to pain management before, during, and after surgery at Mulago National Referral Hospital. It is focussed on adult patients undergoing major surgery. The main questions it aims to answer are:
Information on pain medications will be obtained from patient records. Patients will be asked to rate their pain after surgery every 6 hours for 24 hours.
Study Objectives:
Primary Objectives
Secondary Objective - To determine factors associated with perioperative multimodal analgesia practices at Mulago National Referral Hospital.
Study site: Mulago National Referral Hospital, the largest public hospital in Uganda with a bed capacity of 1500.
Study area: Post Anaesthesia Care Units of the Main Operating Theatre Complex and five inpatient surgical units i.e., Colorectal, Upper Gastrointestinal/Hepatobiliary, Spine, Thoracic, Orthopaedic
Study Population: All adult patients undergoing elective major surgeries in the five surgical units during the study period who meet the eligibility criteria.
Sample size assessment: calculated using the Kish Leslie (1965) formula. Adjusted for a 10% loss to follow up rate and clustering with a design effect of 1.5.
Sampling procedure: Based on monthly surgical averages, participants will be grouped as follows: Colorectal - 105 patients, Upper Gastrointestinal/Hepatobiliary - 84 patients, Spine - 112 patients, Orthopaedic - 126 patients, Thoracic - 22 patients. Consecutive sampling will be done in each of the surgical units until the desired sample size is attained.
Study procedure:
Postoperatively:
- All the systemic analgesic medications and regional analgesic techniques utilised in the postoperative period will be abstracted from the patient's files.
9. Pain intensity after surgery will be measured using the Numeric Rating Scale. The nurse or doctor on duty will be informed if a patient is found with an NRS of ≥4. The research assistants will follow up to ensure that interventions to relieve the patient's pain have been instituted.
Data collection and management Research assistants will undergo data collection training for three days. The abstraction form will be pre-tested before actual data collection on 10 participants who will not be part of the study. Questions will then be refined to ensure their clarity and relevance during the data collection process. All completed forms will be cross-checked for completeness by the Principal Investigator daily. Any errors, incompleteness, or incoherence will be addressed before data storage and entry.
Data will be entered into REDCap electronic data capture software with programmed data checks. The database will be stored on a password-locked hard drive, and the principal investigator's Google Drive will be used as a backup. Data cleaning will be done weekly to ensure quality data is available for analysis.
Data Analysis Data analysis will be carried out using Stata software (version 17). Univariable analysis will be achieved using frequencies with their proportions for categorical data, means with standard deviations for continuous variables with normal distribution, and medians with their interquartile ranges for continuous data with skewed distribution.
Objective 1: To determine the prevalence of perioperative multimodal analgesia practices in adult patients undergoing elective major surgery at Mulago National Referral Hospital.
Descriptive statistics will be used to describe the systemic and/or regional analgesic medications used in the perioperative period (multimodal analgesia practices). Frequencies with their proportions, means with standard deviations, and medians with their interquartile ranges will be reported appropriately. The results will be presented in tables, graphs and charts.
Objective 2 and secondary objective Binary logistic regression will be used to evaluate the association between individual independent variables (including perioperative multimodal analgesia practices) and acute postoperative pain. Variables with a p-value of less than 0.2 in the bivariable analysis will be used in the multivariable analysis. Crude odds ratio (cOR) and their 95% confidence intervals will be reported.
Multivariable logistic regression will be used to evaluate the association between perioperative multimodal analgesia practices and acute postoperative pain, adjusting for other independent variables and controlling for interaction and confounding. Adjusted odds ratios (aOR) and their 95% confidence intervals will be reported. The statistical significance in this study will be determined at a p-value less than 0.05.
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| Measure | Description | Time Frame |
|---|---|---|
| patient-reported acute postoperative pain levels | This will be measured using an 11-point Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain). Pain intensity will be graded as mild (NRS: 1-3), moderate (NRS: 4-6), and severe (NRS: 7-10). | Postoperative pain will be assessed at 0, 6, 12, 18, and 24 hours postoperatively. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who present for surgical treatment at Mulago National Referral Hospital, Kampala City, Uganda
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emmanuel S. Aporu, MBChB | Contact | +256 758662377 | aporu1994@gmail.com | |
| Peter K. Agaba, MBChB, MMed | Contact | Kaahwa39@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Emmanuel S. Aporu, MBChB | Makerere University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mulago National Referral Hospital | Recruiting | Kampala | Uganda |
All IPD that underlie results in a publication
Beginning 6 months after publication upto 2 years after publication
Request must be reasonable. In case of intended statistical analyses, an institutionally approved proposal must be presented.
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| ID | Term |
|---|---|
| D010146 | Pain |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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| D010335 | Pathologic Processes |