Pain Clinical Trial
Official title:
Development and Internal Validation of a Multivariable Risk Prediction Model for Severe Rebound Pain After Lower Limb Orthopedic Surgery Involving Single-Shot Popliteal Sciatic Nerve Blocks: A Single Centre Retrospective Cohort Study
NCT number | NCT05018104 |
Other study ID # | H20-01349 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 4, 2016 |
Est. completion date | July 26, 2022 |
Verified date | October 2022 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Rebound pain is a well-recognized phenomenon after the effects of a nerve block wear off. Severe rebound pain can happen after outpatient surgery, with patients often needing to come back to the hospital or use other health care resources. People who are younger, female or have more pain before surgery are at higher risk of having rebound pain. Bone surgeries and upper limb surgeries also increase the chances of having rebound pain after surgery. Patients who have a tourniquet used during leg surgery often have worse pain after surgery compared to patients who get surgery without the use of a tourniquet. Things that may reduce the chances of getting rebound pain are the use of nerve block catheters, certain additives in nerve blocks and using multiple types of pain killers before the block wears off. Using nerve block catheters can be expensive, so a targeted approach of giving these catheters to patients who have the highest chances of getting rebound pain may be the best way to allocate resources and help patients. The aim of this study is to create and test a risk model for severe rebound pain after lower limb surgery where patients are getting a sciatic nerve block.
Status | Completed |
Enrollment | 1270 |
Est. completion date | July 26, 2022 |
Est. primary completion date | July 26, 2022 |
Accepts healthy volunteers | |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Patients who underwent lower limb surgery and received a single-shot popliteal sciatic nerve block pre-operatively at St. Paul's Hospital from January 4, 2016 to November 1, 2019 Exclusion Criteria: - Patients who had uncontrolled pain (defined as NRS greater than 3 and/or nursing note documentation of uncontrolled or severe pain and/or undocumented pain status) in the post anesthesia care unit (post-operatively) - Patients who received a popliteal sciatic nerve catheter |
Country | Name | City | State |
---|---|---|---|
Canada | St. Paul's Hospital | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Area Under the Receiver Operating Characteristic (ROC) Curve | The Area under the ROC Curve provides a graphical display of sensitivity and specificity and is used to evaluate the discriminative ability of the risk prediction model. | Not a time dependent outcome (retrospective participant pain data up to 48 hours after a nerve block was administered) | |
Primary | Calibration Slope | To evaluate the the degree to which numerical predictions are too high or too low compared to outcomes. | Not a time dependent outcome (model validation test based on retrospective participant pain data up to 48 hours after a nerve block was administered) | |
Secondary | Scaled Brier Score | A proper score function that measures the accuracy of probabilistic predictions. | Not a time dependent outcome (model evaluation/validation test based on retrospective participant pain data up to 48 hours after a nerve block was administered) | |
Secondary | Nagelkerke R2 | An adjusted version of the Cox & Snell R-square that adjusts the scale of the statistic to cover the full range from 0 to 1. | Not a time dependent outcome (model evaluation/validation test based on retrospective participant pain data up to 48 hours after a nerve block was administered) | |
Secondary | Decile Calibration Plots | Decile Calibration Plots will be generated for the final prediction models to further assess calibration, with Loess-smoothed calibration curves created for each imputed dataset. | Not a time dependent outcome (model evaluation/validation test based on retrospective participant pain data up to 48 hours after a nerve block was administered) | |
Secondary | Decision Curve Analysis | The Decision Curve Analysis is a method to evaluate prediction models and diagnostic tests. It will be performed on the final prediction models. | Not a time dependent outcome (model evaluation/validation test based on retrospective participant pain data up to 48 hours after a nerve block was administered) |
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