Orthopedic ProceduresNCT05018104
Risk Model for Severe Rebound Pain After Lower Limb Orthopedic Surgery Involving Single-Shot Sciatic Nerve Blocks
An observational study of Orthopedic Procedures and Pain, Postoperative, run by University of British Columbia at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Orthopedic Procedures, Pain, Postoperative, Surgery
- What is being tested?
- This is not an interventional study
- How many people
- 1,270 participants
- Where
- 1 siteCanada
- Study dates
- 4 Jan 2016to 26 Jul 2022
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: All patients who received a single-shot popliteal sciatic nerve block at St. Paul's Hospital in the study period.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the detailed description
Rebound pain is a well-recognized phenomenon after the resolution of peripheral nerve blocks. Severe rebound pain is prevalent after ambulatory surgery, with potential resultant increased health-care utilization and cost. Risk factors for severe rebound pain may include younger age, female sex, high preoperative pain score, bone surgeries, and upper limb surgeries. Use of tourniquet for lower limb procedures is also associated with worse postoperative pain compared to without. Protective factors may include continuous perineural catheter, regional anesthesia adjuncts, and multimodal oral pain management prior to resolution of peripheral nerve blockade. However, placement of continuous peripheral nerve block catheters utilizes additional health care resources; hence, a targeted approach where continuous perineural catheters are offered to patients at the highest risk of severe rebound pain could potentially offer the biggest benefit.
The aim of the study is to derive and validate a multivariable prediction model for severe rebound pain after lower limb surgery involving popliteal blockade, to assist with risk stratification and shared decision making.
The primary model endpoint is severe rebound pain, defined by transition from well-controlled pain (numerical rating scale [NRS] 3 or less or patient report of satisfactory pain control) in the post anesthetic care unit (PACU) while the block is working to severe pain (NRS pain score 7 or greater) within 48 h of block performance. This definition is modified from that of Barry et al., 2020 as clinically, the investigators have noted some patients having sensory blocks lasting more than 24 hours with the use of adjuncts.
- Conditions
- Orthopedic Procedures, Pain, Postoperative, Surgery, Nerve Block, Ambulatory Surgical Procedures, Pain
- Being tested
- This is not an interventional study
- Keywords
- Rebound Pain, Continous Popliteal Sciatic Nerve Block Catheter, Orthopedic Surgery
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is not an interventional studyOther
This study utilizes data from the St. Paul's Hospital Peripheral Nerve Block Database.
| Study group | Role | What they receive |
|---|---|---|
| Lower Limb Orthopedic Surgery Patients who Received Popliteal Sciatic Nerve Blocks | All patients undergoing lower limb surgery who received popliteal sciatic nerve blocks (with or without other peripheral nerve blocks) at St. Paul's Hospital from January 4, 2016 to November 1, 2019 Receives: Other: This is not an interventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Not a time dependent outcome (retrospective participant pain data up to 48 hours after a nerve block was administered)
Calibration Slope
To evaluate the the degree to which numerical predictions are too high or too low compared to outcomes.
Measured: 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 outcomes (4)
Scaled Brier Score
A proper score function that measures the accuracy of probabilistic predictions.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start4 Jan 2016
- Primary completion26 Jul 2022
- Study completion26 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orthopedic ProceduresStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 1,270 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cynthia Yarnold, University of British Columbia
- Investigators
- Cynthia Yarnold, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05018104
- Sponsor's protocol ID
- H20-01349
- Status last verified
- Oct 2022
- First submitted
- 10 Aug 2021
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jen TTH, Ke JXC, Wing KJ, Denomme J, McIsaac DI, Huang SC, Ree RM, Prabhakar C, Schwarz SKW, Yarnold CH. Development and internal validation of a multivariable risk prediction model for severe rebound pain after foot and ankle surgery involving single-shot popliteal sciatic nerve block. Br J Anaesth. 2022 Jul;129(1):127-135. doi: 10.1016/j.bja.2022.03.030. Epub 2022 May 12.
PubMed 35568510
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05018104
- Acronym / sponsor ID
- H20-01349
- Conditions
- Orthopedic Procedures, Pain, Postoperative, Surgery, Nerve Block, Ambulatory Surgical Procedures, Pain
- Keywords
- Rebound Pain, Continous Popliteal Sciatic Nerve Block Catheter, Orthopedic Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,270 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 4 Jan 2016 (actual)
- Primary completion
- 26 Jul 2022 (actual)
- Study completion
- 26 Jul 2022 (actual)
- First posted
- 24 Aug 2021 (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.
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.
Detailed description
Rebound pain is a well-recognized phenomenon after the resolution of peripheral nerve blocks. Severe rebound pain is prevalent after ambulatory surgery, with potential resultant increased health-care utilization and cost. Risk factors for severe rebound pain may include younger age, female sex, high preoperative pain score, bone surgeries, and upper limb surgeries. Use of tourniquet for lower limb procedures is also associated with worse postoperative pain compared to without. Protective factors may include continuous perineural catheter, regional anesthesia adjuncts, and multimodal oral pain management prior to resolution of peripheral nerve blockade. However, placement of continuous peripheral nerve block catheters utilizes additional health care resources; hence, a targeted approach where continuous perineural catheters are offered to patients at the highest risk of severe rebound pain could potentially offer the biggest benefit.
The aim of the study is to derive and validate a multivariable prediction model for severe rebound pain after lower limb surgery involving popliteal blockade, to assist with risk stratification and shared decision making.
The primary model endpoint is severe rebound pain, defined by transition from well-controlled pain (numerical rating scale [NRS] 3 or less or patient report of satisfactory pain control) in the post anesthetic care unit (PACU) while the block is working to severe pain (NRS pain score 7 or greater) within 48 h of block performance. This definition is modified from that of Barry et al., 2020 as clinically, the investigators have noted some patients having sensory blocks lasting more than 24 hours with the use of adjuncts.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lower Limb Orthopedic Surgery Patients who Received Popliteal Sciatic Nerve Blocks | – | Other: This is not an interventional studyAll patients undergoing lower limb surgery who received popliteal sciatic nerve blocks (with or without other peripheral nerve blocks) at St. Paul's Hospital from January 4, 2016 to November 1, 2019 |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who received a single-shot popliteal sciatic nerve block at St. Paul's Hospital in the study period.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| This is not an interventional studyThis study utilizes data from the St. Paul's Hospital Peripheral Nerve Block Database. | Other | Lower Limb Orthopedic Surgery Patients who Received Popliteal Sciatic Nerve Blocks |
Primary outcome
Area Under the Receiver Operating Characteristic (ROC) Curve
Time frame: Not a time dependent outcome (retrospective participant pain data up to 48 hours after a nerve block was administered)
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.
Calibration Slope
Time frame: Not a time dependent outcome (model validation test based on retrospective participant pain data up to 48 hours after a nerve block was administered)
To evaluate the the degree to which numerical predictions are too high or too low compared to outcomes.
4 secondary outcomes
Scaled Brier Score
Time frame: 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)
Nagelkerke R2
Time frame: 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)
Decile Calibration Plots
Time frame: 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)
Decision Curve Analysis
Time frame: 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)
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 1 Nov 2022.
- Derived from this study: PubMed 35568510Jen TTH, Ke JXC, Wing KJ, Denomme J, McIsaac DI, Huang SC, Ree RM, Prabhakar C, Schwarz SKW, Yarnold CH. Development and internal validation of a multivariable risk prediction model for severe rebound pain after foot and ankle surgery involving single-shot popliteal sciatic nerve block. Br J Anaesth. 2022 Jul;129(1):127-135. doi: 10.1016/j.bja.2022.03.030. Epub 2022 May 12.
- Individual participant dataSharing planned: No
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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.
Cynthia Yarnold, MD principal investigator
University of British Columbia
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 Orthopedic Procedures and Pain, Postoperative, run by University of British Columbia at 1 site in Canada.
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 1 inclusion and 2 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 1 Nov 2022. 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 Canada. 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?
Area Under the Receiver Operating Characteristic (ROC) Curve (time frame: Not a time dependent outcome (retrospective participant pain data up to 48 hours after a nerve block was administered)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05018104, which also lists 1 linked publication.
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 1 Nov 2022.