CSF Single-cell Sequencing and Proteomics of Chronic Postsurgical Pain in Patients With Lower Limb Fractures

NCT06126289 | Unknown DMC

• 1 other identifier: XZXY-LK-20230530-084
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess the proteomics and transcriptomic differences between pain-free control subjects and patients with chronic postoperative pain through single-cell sequencing technology.

Conditions

Chronic Postsurgical Pain

Keywords

Chronic Postsurgical pain; Single-cell sequencing; Cerebrospinal Fluid

Outcome Measures

Primary Outcomes (2)

• Significantly different proteomics and transcriptomes between Chronic Postsurgical Pain and pain-free subjects

  Differences in the proteins in the fluid around the lumbar, between Chronic Postsurgical Pain and Pain-free subjects.，will be quantified using Mass spectrometry，for: neural cell adhesion molecule L1, complement C4-A, lysozyme C, receptor-type tyrosine-protein phosphatase zeta, apolipoprotein D, alpha-1-antichymotrypsin, granulins, calcium/calmodulin-dependent protein kinase type II subunit alpha, mast/stem cell growth factor receptor Kit, prolow-density lipoprotein receptor-related protein 1 and so on. These proteins may identify the disease and define its mechanism.

  Up to 3 months after fixation

• Inflammatory cytokines in Chronic Postsurgical Pain patients

  Biomarkers from CSF will be quantified using Meso Scale Discovery multiplex kit (K15210D), for: CRP, Eotaxin, Eotaxin-3, FGF (basic), ICAM-1, IFN-γ, IL-1α, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12/IL-23p40, IL-13, IL-15, IL-16, IL-17A, IP-10, MCP-1, MCP-4, MDC, MIP-1α, MIP-1β, PlGF, SAA, TARC, Tie-2, TNF-α, TNF-β, VCAM-1, VEGF-A, VEGF-C, VEGF-D, VEGFR-1/Flt-1. The levels of these biomarkers will be compared between the group between CPSP and pain-free subjects.

  Up to 3 months after fixation surgery

Study Arms (2)

Pain-free control subjects

According to the 11th Revision of International Classification of Diseases (ICD-11) of International Association for the Study of Pain(IASP) in 2019, diagnose whether patients have CPSP . Patients with no postoperative chronic pain after open reduction and internal fixation of lower limb fractures.

Patients with chronic postsurgical pain

According to the 11th Revision of International Classification of Diseases (ICD-11) of International Association for the Study of Pain(IASP) in 2019, diagnose whether patients have CPSP . Patients with postsurgical chronic pain after open reduction and internal fixation of lower limb fractures.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who had undergone open reduction and internal fixation of the lower limbs and planned to take out the internal fixation were interviewed before surgery to collect the basic data ( gender, age, BMI, etc. ) and previous surgical information. Selecting the patients with the chronic postoperative pain，for one-to-one case matching.All patients and control subjects were without any analgesic medicatio during the 24hours before the investigation,and were not using any daily mediciation.Routine blood and urine assessments were within the normal range.

You may qualify if:

• ASA physical status 1 to 3 (males and females)
• Undergone open reduction and internal fixation of the lower limbs and plan to take out the internal fixation under spinal anesthesia

You may not qualify if:

• Absence of written consent
• Contraindication to regional anaesthesia
• Known dementia at time of operation
• History or opioid abuse
• Unexpected conversion of general anesthesia or surgery is not carried out

Sponsors & Collaborators

• Xuzhou Central Hospital: lead

Related Publications (10)

• 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

• 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 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

• 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 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Patients undergoing hardware removal following open reduction internal fixation of lower limb fractures under spinal anesthesia will be enrolled in the study. The anesthesiologist retained cerebrospinal fluid during a subarachnoid puncture.

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Yang Zi D Zhu, Doctor

CONTACT

+86 18168779150; zhuyz@188.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 13, 2023
• Study Start: December 25, 2023
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: November 13, 2023

Record last verified: 2023-06