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

NCT06136663 | Unknown DMC

• 1 other identifier: XZXY-LK-20230530-085
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Post Operative Pain

Outcome Measures

Primary Outcomes (11)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Refusing to participate in this study.

Sponsors & Collaborators

• Xuzhou Central Hospital: lead

Study Sites (1)

Xuzhou Central Hospital

Xuzhou, Jiangsu, 221009, China

Location

Related Publications (12)

• 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.

  PMID: 30586071 BACKGROUND

• 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.

  PMID: 28707777 BACKGROUND

• 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.

  PMID: 30496104 BACKGROUND

• 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.

  PMID: 22518366 BACKGROUND

• 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.

  PMID: 27106969 BACKGROUND

• 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.

  PMID: 36367768 BACKGROUND

• 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.

  PMID: 12165466 BACKGROUND

• 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.

  PMID: 34062144 BACKGROUND

• 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.

  PMID: 34285154 BACKGROUND

• 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.

  PMID: 28134653 BACKGROUND

• 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.

  PMID: 31601595 RESULT

• 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.

  PMID: 35926071 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 18, 2023
• Study Start: December 1, 2023
• Primary Completion: February 28, 2024
• Study Completion: March 30, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-10

Locations

CN (1)