A Prospective Cohort Survey on Prevalence and Risk Factors for Persistent Postsurgical Pain After the Open Reduction and Internal Fixation of the Lower Limbs
Sponsor study identifier
observational
1,000
1 country
1
Study Start
December 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
February 28, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 31, 2023
Actual (reported)November 18, 2023
Actual (reported)December 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 28, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Postoperative chronic pain：pain score
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
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
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
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
The use of the analgesic drugs， including the past and this perioperative period
Up to 10 days
Surgery details
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
The types of anesthesia (general anesthesia, spinal anesthesia and whether to use nerve block, etc. )
Baseline
Age
The age of each subject in the operating room was counted.
Baseline
Body mass index (BMI)
The BMI of each subject in the operating room was counted and compared.
Baseline
Gender
The gender ratio of the CPSP group and pain-free group was recorded and compared.
Baseline
Cultural background
Record the highest academic qualifications of the subjects.
Baseline
Patients with no postoperative chronic pain after open reduction and internal fixation of lower limb fractures.
Patients with postsurgical chronic pain after open reduction and internal fixation of lower limb fractures.
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.
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221009, China
Scholz J, Finnerup NB, Attal N, Aziz Q, Baron R, Bennett MI, Benoliel R, Cohen M, Cruccu G, Davis KD, Evers S, First M, Giamberardino MA, Hansson P, Kaasa S, Korwisi B, Kosek E, Lavand'homme P, Nicholas M, Nurmikko T, Perrot S, Raja SN, Rice ASC, Rowbotham MC, Schug S, Simpson DM, Smith BH, Svensson P, Vlaeyen JWS, Wang SJ, Barke A, Rief W, Treede RD; Classification Committee of the Neuropathic Pain Special Interest Group (NeuPSIG). The IASP classification of chronic pain for ICD-11: chronic neuropathic pain. Pain. 2019 Jan;160(1):53-59. doi: 10.1097/j.pain.0000000000001365.
van Ransbeeck A, Budilivski A, Spahn DR, Macrea L, Giuliani F, Maurer K. Pain Assessment Discrepancies: A Cross-Sectional Study Highlights the Amount of Underrated Pain. Pain Pract. 2018 Mar;18(3):360-367. doi: 10.1111/papr.12612. Epub 2017 Sep 20.
First Submitted
October 31, 2023
First Posted
November 18, 2023
Study Start
December 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
February 28, 2024
Estimated (date passed)Effect of Perioperative Dexmedetomidine on Chronic Post-Surgical Pain
Contact the study team to confirm eligibility.
GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8.
Clay FJ, Watson WL, Newstead SV, McClure RJ. A systematic review of early prognostic factors for persisting pain following acute orthopedic trauma. Pain Res Manag. 2012 Jan-Feb;17(1):35-44. doi: 10.1155/2012/935194.
Friesgaard KD, Gromov K, Knudsen LF, Brix M, Troelsen A, Nikolajsen L. Persistent pain is common 1 year after ankle and wrist fracture surgery: a register-based questionnaire study. Br J Anaesth. 2016 May;116(5):655-61. doi: 10.1093/bja/aew069.
Leliveld MS, Van Lieshout EMM, Polinder S, Verhofstad MHJ; TRAVEL Study Investigators. Effect of Transverse Versus Longitudinal Incisions on Anterior Knee Pain After Tibial Nailing (TRAVEL): A Multicenter Randomized Trial with 1-Year Follow-up. J Bone Joint Surg Am. 2022 Dec 21;104(24):2160-2169. doi: 10.2106/JBJS.22.00389. Epub 2022 Oct 25.
Wyss-Coray T, Mucke L. Inflammation in neurodegenerative disease--a double-edged sword. Neuron. 2002 Aug 1;35(3):419-32. doi: 10.1016/s0896-6273(02)00794-8.
Fitzcharles MA, Cohen SP, Clauw DJ, Littlejohn G, Usui C, Hauser W. Nociplastic pain: towards an understanding of prevalent pain conditions. Lancet. 2021 May 29;397(10289):2098-2110. doi: 10.1016/S0140-6736(21)00392-5.
Hankerd K, McDonough KE, Wang J, Tang SJ, Chung JM, La JH. Postinjury stimulation triggers a transition to nociplastic pain in mice. Pain. 2022 Mar 1;163(3):461-473. doi: 10.1097/j.pain.0000000000002366.
Lavand'homme P. Transition from acute to chronic pain after surgery. Pain. 2017 Apr;158 Suppl 1:S50-S54. doi: 10.1097/j.pain.0000000000000809. No abstract available.
Rees S, Tutton E, Achten J, Bruce J, Costa ML. Patient experience of long-term recovery after open fracture of the lower limb: a qualitative study using interviews in a community setting. BMJ Open. 2019 Oct 9;9(10):e031261. doi: 10.1136/bmjopen-2019-031261.
Van Wyngaarden JJ, Archer KR, Pennings JS, Matuszewski PE, Noehren B. Psychosocial Predictors of Chronic Pain 12 Months After Surgical Fixation for Lower Extremity Fracture: A Prospective Study. Phys Ther. 2022 Oct 6;102(10):pzac101. doi: 10.1093/ptj/pzac101.
Zhu Y, Wu Y, Gao K, Sun Y, Hu J, Wang L, Cao JL. Risk Factors and Prediction of Chronic Postsurgical Pain Among Patients With Distal Lower Extremity Fracture: Cohort Analysis. Anesth Analg. 2026 Sep 1;143(3):614-624. doi: 10.1213/ANE.0000000000007902. Epub 2026 Jan 14.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 18, 2023
Record last verified: 2023-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: