Risk Model for Severe Rebound Pain After Lower Limb Orthopedic Surgery Involving Single-Shot Sciatic Nerve Blocks

NCT05018104 | Completed

• 1 other identifier: H20-01349
• Study Type: observational
• Target: 1,270
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Orthopedic Procedures; Pain, Postoperative; Surgery; Nerve Block; Ambulatory Surgical Procedures; Pain

Keywords

Rebound Pain; Continous Popliteal Sciatic Nerve Block Catheter; Orthopedic Surgery

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (4)

• Scaled Brier Score

  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

  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

  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

  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)

Study Arms (1)

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

Other: This is not an interventional study

Interventions

This is not an interventional study OTHER

This study utilizes data from the St. Paul's Hospital Peripheral Nerve Block Database.

Lower Limb Orthopedic Surgery Patients who Received Popliteal Sciatic Nerve Blocks

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who received a single-shot popliteal sciatic nerve block at St. Paul's Hospital in the study period.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Related Publications (1)

• 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.

  PMID: 35568510 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Cynthia Yarnold, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: August 24, 2021
• Study Start: January 4, 2016
• Primary Completion: July 26, 2022
• Study Completion: July 26, 2022
• Last Updated: November 1, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)