Prevalence and Risk Factors for Postsurgical Pain After the Open Reduction and Internal Fixation of Lower Limbs.

November 14, 2023 updated by: Xuzhou Central Hospital

A Prospective Cohort Survey on Prevalence and Risk Factors for Persistent Postsurgical Pain After the Open Reduction and Internal Fixation of the Lower Limbs

The objective of this study is to specify the demographic and medical factors that most likely constitute a risk of developing CPSP in the patients with lower limb.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

Chronic pain,one of the most frequent causes for patients to seek medical care,is a recognized health problem.Chronic postsurgical pain (CPSP), commonly defined as pain that develops after a surgical procedure and persists at least 3 months, constitutes a widely underdiagnosed and often poorly treated medical problem affecting 10-50% of all postsurgical patients. According to the reports,in the United States alone,1.9 million persons abused or were dependent on prescription opioid analgesics for chronic pain in 2013,contributing to one of the worst public health crises the developed world has recently faced.Here,open reduction and internal fixation（ORIF） of lower limb fractures ,what the investigators focus, is a common surgical procedure in orthopedics and microscopic hand and foot surgery.The removal of the intramedullary nail can relieve anterior knee pain, but in a substantial number of patients, pain persists after nail removal.The most painful daily activities are kneeling and squatting.Therefore, it is increasingly important and urgent to solve the postoperative chronic pain of patients with lower extremity fractures surgery.

The underlying biology of chronic postoperative pain and genetic heritability is complex and not yet fully understood . A common feature of CPSP is that the painful sensations change from the familiar acute postoperative pain to a complex pain syndrome with nonaplastic characteristics，neuropathic characteristics, or both. Preclinical studies have revealed that neuroinflammation is one of pathological hallmarks of CPSP. The transition from acute to chronic pain starts early within the first 2 weeks after nonaplastic by peripheral and central inflammatory processes and activation of spinal glial cells.Repetitive nociception resulting from prolonged inflammatory and neuropathic responses to noxious stimuli causes a cascade of biochemical and structural changes to various pain pathways resulting in sensitization of the peripheral and central nervous system（CNS）. Cytokines and neurotrophic factors have been identified as pivotal mediators involved in neuroimmune activation pathways and cascades in various preclinical chronic pain models.

Although lower limb fracture is one of the most frequently reported triggering CPSP events, few large-scale studies have shown the occurrence of and factors associated with it.The objectives of investigators are to specify the demographic and medical factors that most likely constitute a risk of developing CPSP and to search for potential interventions to reduce the occurrence of CPSP in these limb fracture patients.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Xuzhou, Jiangsu, China, 221009
        • Xuzhou Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients admitted to trauma center for lower fracture (femur, tibia, patella, or foot/ankle) requiring open-reduction internal fixation were screened for inclusion between January 2020 and March 2023. Demographic questions are completed at the time of consent, and the mechanism of injury, primary injury location, body mass index, blood and urine assessments are extracted from each individual's medical record. Additionally, at 3 months each participant was asked whether they had developed chronic pain and completed a validated measure of self-reported pain intensity.

Description

Inclusion Criteria:

  • Underwent surgical repair including fracture of the lower leg, fracture of the foot and fractures involving multiple regions of the lower limbs.

Exclusion Criteria:

  • Refusing to participate in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Pain-free control subjects
Patients with no postoperative chronic pain after open reduction and internal fixation of lower limb fractures.
Patients with chronic postsurgical pain
Patients with postsurgical chronic pain after open reduction and internal fixation of lower limb fractures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative chronic pain：pain score
Time Frame: Through study completion, an average of 1 year
  1. Postoperative chronic pain assessed by the Numerical Rating Scale (NRS). Pain score >=3 at operational areas (minimum 0, maximum 10, higher score indicates greater pain).
  2. Pain developed after a surgical procedure or increased in intensity after the surgical procedure.
  3. Pain should be of at least 3 months duration with a significant negative effect on the quality of life.
  4. Pain is a continuation of acute postoperative pain or may develop after an asymptomatic period and pain is localized to the surgical field or to a referred area (eg, innervation territory, referred dermatome for visceral surgery).
  5. Other possible causes for the pain have been excluded (eg, infection, cancer recurrence)
Through study completion, an average of 1 year
Perioperative inflammatory state
Time Frame: Up to 10 days
The inflammatory factors，C-reactive protein（CRP）, white blood cell count, and lymphocyte ratio of the subjects were counted.
Up to 10 days
Lifestyle and behaviour of the subjects
Time Frame: Baseline
Through the electronic medical record system and telephone follow-up, to understand whether there is a history of smoking, drinking, physical activity.
Baseline
Preoperative complications of the participants
Time Frame: Baseline
Including cardiovascular and cerebrovascular diseases (such as hypertension, coronary heart disease), respiratory diseases (such as chronic obstructive pulmonary disease), endocrine system diseases (such as diabetes, hyperthyroidism) and so on.
Baseline
Medical interventions history
Time Frame: Up to 10 days
The use of the analgesic drugs， including the past and this perioperative period
Up to 10 days
Surgery details
Time Frame: Baseline
Including specific surgical site (femur, tibia or fibula or multiple injuries) ，the time of operation, the amount of bleeding during operation，etc.
Baseline
Anesthesia during surgery
Time Frame: Baseline
The types of anesthesia (general anesthesia, spinal anesthesia and whether to use nerve block, etc. )
Baseline
Age
Time Frame: Baseline
The age of each subject in the operating room was counted.
Baseline
Body mass index (BMI)
Time Frame: Baseline
The BMI of each subject in the operating room was counted and compared.
Baseline
Gender
Time Frame: Baseline
The gender ratio of the CPSP group and pain-free group was recorded and compared.
Baseline
Cultural background
Time Frame: Baseline
Record the highest academic qualifications of the subjects.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuzhou Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

February 28, 2024

Study Completion (Estimated)

March 30, 2024

Study Registration Dates

First Submitted

October 31, 2023

First Submitted That Met QC Criteria

November 14, 2023

First Posted (Estimated)

November 17, 2023

Study Record Updates

Last Update Posted (Estimated)

November 17, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XZXY-LK-20230530-085

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Post Operative Pain

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe