Incidence of Neuraxial and Non-neuraxial Hematoma Complications From Spinal Cord Stimulator Surgery: Systematic Review and Proportional Meta-Analysis



      The goal of this meta-analysis was to estimate the incidence of total hematomas, neuraxial hematomas, and non-neuraxial hematomas in patients who underwent temporary spinal cord stimulator (SCS) lead trial placement and permanent implantation of SCS leads and internal pulse generator (IPG).

      Materials and Methods

      A comprehensive search was conducted of databases of any publications before October 21, 2021. Eligible study designs included randomized control trials and prospective or retrospective observational studies with more than ten patients. The primary outcome variables were the incidences of total hematomas, neuraxial hematomas, and non-neuraxial hematomas in patients with SCS. These dichotomous categorical outcomes were abstracted from studies after Freeman-Tukey arcsine square root transformation using random-effects meta-analysis (DerSimonian and Laird method). Pooled incidence rates and 95% CIs were calculated for each outcome variable.


      A total of 40 studies met the inclusion criteria. Included in the neuraxial and non-neuraxial hematoma analyses were 4751 patients and 3862 patients, respectively. The pooled incidence of any hematoma in patients with SCS was 0.81% (95% CI, 0.45%–1.27%). The pooled incidence of neuraxial hematoma in patients with SCS was 0.32% (95% CI, 0.18%–0.50%). This included primarily epidural hematomas (11/4751) but also comprised an intracranial hemorrhage in a patient on enoxaparin bridge therapy from warfarin and one patient not on anticoagulation with an intracranial subdural hematoma that resulted in death. The pooled incidence of non-neuraxial hematomas in patients with SCS was 0.59% (95% CI, 0.29%–1.00%).


      The overall incidence of hematomas in patients with temporary SCS trial lead placement and permanent SCS/IPG implantations is less than 1%. Furthermore, the incidence of neuraxial hematomas is less than 0.5%, which is of particular interest given the potential devastating consequences of this complication. The results of this study can be used to inform patients and implanting physicians on hematoma complications from SCS and highlight that the benefits of SCS outweigh the hematoma risks if anticoagulation is appropriately managed perioperatively.


      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


      Subscribe to
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • Rock A.K.
        • Truong H.
        • Park Y.L.
        • Pilitsis J.G.
        Spinal cord stimulation.
        Neurosurg Clin N Am. 2019; 30: 169-194
        • Bates D.
        • Schultheis B.C.
        • Hanes M.C.
        • et al.
        A comprehensive algorithm for management of neuropathic pain.
        Pain Med. 2019; 20: S2-S12
        • Lee A.W.
        • Pilitsis J.G.
        Spinal cord stimulation: indications and outcomes.
        Neurosurg Focus. 2006; 21: E3
        • Hagedorn J.M.
        • Pittelkow T.P.
        • Hunt C.L.
        • D'Souza R.S.
        • Lamer T.J.
        Current perspectives on spinal cord stimulation for the treatment of cancer pain.
        J Pain Res. 2020; 13: 3295-3305
        • D'Souza R.S.
        • Langford B.
        • Dombovy-Johnson M.
        • Abd-Elsayed A.
        Neuromodulation interventions for the treatment of painful diabetic neuropathy: a systematic review.
        Curr Pain Headache Rep. 2022; 26: 365-377
        • Christelis N.
        • Simpson B.
        • Russo M.
        • et al.
        Persistent spinal pain syndrome: a proposal for failed back surgery syndrome and ICD-11.
        Pain Med. 2021; 22: 807-818
      1. D'Souza RS, Barman RA, Joseph A, Abd-Elsayed A. Evidence-based treatment of painful diabetic neuropathy: a systematic review. Curr Pain Headache Rep. Published online June 18, 2022.

        • D'Souza R.S.
        • Hunt C.L.
        A rare case of anchor fracture manifesting with new-onset neuropathic pain after spinal cord stimulator implantation.
        Neuromodulation. 2022; 25: 783-785
        • D'Souza R.S.
        • Olatoye O.O.
        • Butler C.S.
        • Barman R.A.
        • Ashmore Z.M.
        • Hagedorn J.M.
        Adverse events associated with 10-kHz dorsal column spinal cord stimulation: a 5-year analysis of the Manufacturer and User Facility Device Experience (MAUDE) database.
        Clin J Pain. 2022; 38: 320-327
        • Eldabe S.
        • Buchser E.
        • Duarte R.V.
        Complications of spinal cord stimulation and peripheral nerve stimulation techniques: a review of the literature.
        Pain Med. 2016; 17: 325-336
        • Hagedorn J.M.
        • Lam C.M.
        • D'Souza R.S.
        • et al.
        Explantation of 10 kHz spinal cord stimulation devices: a retrospective review of 744 patients followed for at least 12 months.
        Neuromodulation. 2021; 24: 499-506
        • Page M.J.
        • McKenzie J.E.
        • Bossuyt P.M.
        • et al.
        The PRISMA 2020 statement: an updated guideline for reporting systematic reviews.
        BMJ. 2021; 372: n71
        • Page M.J.
        • Shamseer L.
        • Tricco A.C.
        Registration of systematic reviews in PROSPERO: 30,000 records and counting.
        Syst Rev. 2018; 7: 32
        • Shamseer L.
        • Moher D.
        • Clarke M.
        • et al.
        Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation.
        BMJ. 2015; 350: g7647
        • Freeman M.F.
        • Tukey J.W.
        Transformations related to the angular and the square root.
        Ann Math Statist. 1950; 21: 607-611
        • DerSimonian R.
        • Laird N.
        Meta-analysis in clinical trials.
        Control Clin Trials. 1986; 7: 177-188
      2. Hagedorn JM, Romero J, Ha CT, D'Souza RS. Patient satisfaction with spinal cord stimulation and dorsal root ganglion stimulation for chronic intractable pain: a systematic review and meta-analysis. Neuromodulation. Published online June 8, 2022.

        • Al-Kaisy A.
        • Royds J.
        • Costanzi M.
        • et al.
        Effectiveness of “transgrade” epidural technique for dorsal root ganglion stimulation. A retrospective, single-center, case series for chronic focal neuropathic pain.
        Pain Phys. 2019; 22: 601-611
        • Amirdelfan K.
        • Vallejo R.
        • Benyamin R.
        • et al.
        High-Frequency spinal cord stimulation at 10 kHz for the treatment of combined neck and arm pain: results from a prospective multicenter study.
        Neurosurgery. 2020; 87: 176-185
        • Amrani J.
        A novel technique for the implantation of paddle leads in the cervical spine.
        Neuromodulation. 2013; 16 ([discussion: 550]): 546-550
        • Barolat G.
        Experience with 509 plate electrodes implanted epidurally from C1 to L1.
        Stereotact Funct Neurosurg. 1993; 61: 60-79
        • Rigoard P.
        • Billot M.
        • Ingrand P.
        • et al.
        How should we use multicolumn spinal cord stimulation to optimize back pain spatial neural targeting? A prospective, multicenter, randomized, double-blind, controlled trial (ESTIMET study).
        Neuromodulation. 2021; 24: 86-101
        • Burgher A.
        • Kosek P.
        • Surrett S.
        • et al.
        Ten kilohertz SCS for treatment of chronic upper extremity pain (UEP): results from prospective observational study.
        J Pain Res. 2020; 13: 2837-2851
        • Colombo E.V.
        • Mandelli C.
        • Mortini P.
        • et al.
        Epidural spinal cord stimulation for neuropathic pain: a neurosurgical multicentric Italian data collection and analysis.
        Acta neurochir. 2015; 157: 711-720
        • De Andres J.
        • Monsalve-Dolz V.
        • Fabregat-Cid G.
        • et al.
        Prospective, randomized blind effect-on-outcome study of conventional vs high-frequency spinal cord stimulation in patients with pain and disability due to failed back surgery syndrome.
        Pain Med. 2017; 18: 2401-2421
        • Deer T.
        • Bowman R.
        • Schocket S.M.
        • et al.
        The prospective evaluation of safety and success of a new method of introducing percutaneous paddle leads and complex arrays with an epidural access system.
        Neuromodulation. 2012; 15 ([discussion: 29–30]): 21-29
        • Deer T.R.
        • Levy R.M.
        • Kramer J.
        • et al.
        Dorsal root ganglion stimulation yielded higher treatment success rate for complex regional pain syndrome and causalgia at 3 and 12 months: a randomized comparative trial.
        Pain. 2017; 158: 669-681
        • Deer T.R.
        • Falowski S.M.
        • Moore G.A.
        • et al.
        Passive recharge burst spinal cord stimulation provides sustainable improvements in pain and psychosocial function: 2-year results from the TRIUMPH Study.
        Spine (Phila Pa 1976). 2022; 47: 548-556
        • Donas K.P.
        • Schulte S.
        • Ktenidis K.
        • Horsch S.
        The role of epidural spinal cord stimulation in the treatment of Buerger’s disease.
        J Vasc Surg. 2005; 41: 830-836
        • Falowski S.M.
        • Sharan A.
        • McInerney J.
        • Jacobs D.
        • Venkatesan L.
        • Agnesi F.
        Nonawake vs awake placement of spinal cord stimulators: a prospective, multicenter study comparing safety and efficacy.
        Neurosurgery. 2019; 84: 198-205
        • Fiume D.
        • Sherkat S.
        • Callovini G.M.
        • Parziale G.
        • Gazzeri G.
        Treatment of the failed back surgery syndrome due to lumbo-sacral epidural fibrosis.
        Acta neurochir Suppl. 1995; 64: 116-118
        • Gatzinsky K.
        • Baardsen R.
        • Buschman H.P.
        Evaluation of the effectiveness of percutaneous octapolar leads in pain treatment with spinal cord stimulation of patients with failed back surgery syndrome During a 1-year follow-up: a prospective multicenter international study.
        Pain Pract. 2017; 17: 428-437
        • Geurts J.W.
        • Smits H.
        • Kemler M.A.
        • Brunner F.
        • Kessels A.G.H.
        • van Kleef M.
        Spinal cord stimulation for complex regional pain syndrome type I: a prospective cohort study with long-term follow-up.
        Neuromodulation. 2013; 16 ([discussion: 529]): 523-529
        • Hagedorn J.M.
        • Deer T.R.
        • Falowski S.M.
        • et al.
        An observational study of intraoperative neuromonitoring as a safety mechanism in placement of percutaneous dorsal root ganglion stimulation and spinal cord stimulation systems.
        J Pain Res. 2020; 13: 3349-3353
        • Kapural L.
        • Yu C.
        • Doust M.W.
        • et al.
        Novel 10-kHz high-frequency therapy (HF10 therapy) is superior to traditional low-frequency spinal cord stimulation for the treatment of chronic back and leg pain: the SENZA-RCT randomized controlled trial.
        Anesthesiology. 2015; 123: 851-860
        • Khan H.
        • Kumar V.
        • Ghulam-Jelani Z.
        • et al.
        Safety of spinal cord stimulation in patients who routinely use anticoagulants.
        Pain Med. 2018; 19: 1807-1812
        • Kleiber J.C.
        • Marlier B.
        • Bannwarth M.
        • Theret E.
        • Peruzzi P.
        • Litre F.
        Is spinal cord stimulation safe? A review of 13 years of implantations and complications.
        Rev neurol (Paris). 2016; 172: 689-695
        • Kumar K.
        • Hunter G.
        • Demeria D.
        Spinal cord stimulation in treatment of chronic benign pain: challenges in treatment planning and present status, a 22-year experience.
        Neurosurgery. 2006; 58 ([discussion: 481–496]): 481-496
        • Lillemäe K.
        • Järviö J.A.
        • Silvasti-Lundell M.K.
        • Antinheimo J.J.-P.
        • Hernesniemi J.A.
        • Niemi T.T.
        Incidence of postoperative hematomas requiring surgical treatment in neurosurgery: a retrospective observational study.
        World Neurosurg. 2017; 108: 491-497
        • Moeschler S.M.
        • Warner N.S.
        • Lamer T.J.
        • et al.
        Bleeding complications in patients undergoing percutaneous spinal cord stimulator trials and implantations.
        Pain Med. 2016; 17: 2076-2081
        • Moufarrij N.A.
        Epidural hematomas after the implantation of thoracic paddle spinal cord stimulators.
        J Neurosurg. 2016; 125: 982-985
        • Nissen M.
        • Ikäheimo T.M.
        • Huttunen J.
        • Leinonen V.
        • Von Und Zu Fraunberg M.
        Long-term outcome of spinal cord stimulation in failed back surgery syndrome: 20 years of Experiencewith 224 consecutive patients.
        Neurosurgery. 2019; 84: 1011-1018
        • Oakley J.C.
        • Krames E.S.
        • Prager J.P.
        • et al.
        A new spinal cord stimulation system effectively relieves chronic, intractable pain: a multicenter prospective clinical study.
        Neuromodulation. 2007; 10: 262-278
        • Petersen E.A.
        • Stauss T.G.
        • Scowcroft J.A.
        • et al.
        Effect of high-frequency (10-kHz) spinal cord stimulation in patients With painful diabetic neuropathy: a randomized clinical trial.
        JAMA Neurol. 2021; 78: 687-698
        • Piedade G.S.
        • Vesper J.
        • Chatzikalfas A.
        • Slotty P.J.
        Cervical and high-thoracic dorsal root ganglion stimulation in chronic neuropathic pain.
        Neuromodulation. 2019; 22: 951-955
        • Rigoard P.
        • Basu S.
        • Desai M.
        • et al.
        Multicolumn spinal cord stimulation for predominant back pain in failed back surgery syndrome patients: a multicenter randomized controlled trial.
        Pain. 2019; 160: 1410-1420
        • Schoen N.
        • Chieng L.O.
        • Madhavan K.
        • Jermakowicz W.J.
        • Vanni S.
        The use of intraoperative electromyogram During spinal cord stimulator placement surgery: a case series.
        World Neurosurg. 2017; 100: 74-84
        • Simopoulos T.
        • Sharma S.
        • Aner M.
        • Gill J.S.
        A temporary vs. permanent anchored percutaneous lead trial of spinal cord stimulation: a comparison of patient outcomes and adverse events.
        Neuromodulation. 2018; 21: 508-512
        • Slangen R.
        • Schaper N.C.
        • Faber C.G.
        • et al.
        Spinal cord stimulation and pain relief in painful diabetic peripheral neuropathy: a prospective two-center randomized controlled trial.
        Diabetes Care. 2014; 37: 3016-3024
        • Spincemaille G.H.
        • Klomp H.M.
        • Steyerberg E.W.
        • van Urk H.
        • Habbema J.D.
        • ESES study group
        Technical data and complications of spinal cord stimulation: data from a randomized trial on critical limb ischemia.
        Stereotact Funct Neurosurg. 2000; 74: 63-72
        • Van Gorp E.J.
        • Teernstra O.P.
        • Gültuna I.
        • et al.
        Subcutaneous stimulation as ADD-ON therapy to spinal cord stimulation is effective in treating low back pain in patients with failed back surgery syndrome: a multicenter randomized controlled trial.
        Neuromodulation. 2016; 19: 171-178
        • Velásquez C.
        • Tambirajoo K.
        • Franceschini P.
        • Eldridge P.R.
        • Farah J.O.
        Upper cervical spinal cord stimulation as an alternative treatment in trigeminal neuropathy.
        World Neurosurg. 2018; 114: e641-e646
        • Wan C.F.
        • Song T.
        Efficacy of pulsed radiofrequency or short-term spinal cord stimulation for acute/subacute zoster-related pain: a randomized, double-blinded, controlled trial.
        Pain Phys. 2021; 24: 215-222
        • Wesselink W.A.
        • Holsheimer J.
        • King G.W.
        • Torgerson N.A.
        • Boom H.B.
        Quantitative aspects of the clinical performance of transverse tripolar spinal cord stimulation.
        Neuromodulation. 1999; 2: 5-14
        • Wolter T.
        • Kieselbach K.
        Cervical spinal cord stimulation: an analysis of 23 patients with long-term follow-up.
        Pain Phys. 2012; 15: 203-212
        • Zan E.
        • Kurt K.N.
        • Yousem D.M.
        • Christo P.J.
        Spinal cord stimulators: typical positioning and postsurgical complications.
        AJR Am J Roentgenol. 2011; 196: 437-445
        • van Bussel C.M.
        • Stronks D.L.
        • Huygen F.J.P.M.
        Dorsal Column Stimulation vs. Dorsal Root Ganglion Stimulation for Complex Regional Pain Syndrome Confined to the Knee: patients' Preference Following the Trial Period.
        Pain Pract. 2018; 18: 87-93
        • Deer T.R.
        • Narouze S.
        • Provenzano D.A.
        • et al.
        The Neurostimulation Appropriateness Consensus Committee (NACC): recommendations on bleeding and coagulation management in neurostimulation devices.
        Neuromodulation. 2017; 20: 51-62
        • Narouze S.
        • Benzon H.T.
        • Provenzano D.
        • et al.
        Interventional Spine and Pain Procedures in Patients on Antiplatelet and Anticoagulant Medications (Second Edition): guidelines from the American Society of Regional Anesthesia and Pain Medicine, the European Society of Regional Anaesthesia and Pain Therapy, the American Academy of Pain Medicine, the International Neuromodulation Society, the North American Neuromodulation Society, and the World Institute of Pain.
        Reg Anesth Pain Med. 2018; 43: 225-262
        • D'Souza R.S.
        • Hagedorn J.M.
        Anticoagulation use during dorsal column spinal cord stimulation trial.
        Pain Med. 2020; 21: 2595-2598
        • Tafur A.J.
        • Clark N.P.
        • Spyropoulos A.C.
        • et al.
        Predictors of bleeding in the perioperative anticoagulant use for surgery evaluation study.
        J Am Heart Assoc. 2020; 9e017316
        • Abd-Elsayed A.
        • D'Souza R.S.
        Peripheral nerve stimulation: the evolution in pain medicine.
        Biomedicines. 2021; : 10
        • Strand N.H.
        • D'Souza R.
        • Wie C.
        • et al.
        Mechanism of action of peripheral nerve stimulation.
        Curr Pain Headache Rep. 2021; 25: 47
        • Bos E.M.E.
        • Haumann J.
        • de Quelerij M.
        • et al.
        Haematoma and abscess after neuraxial anaesthesia: a review of 647 cases.
        Br J Anaesth. 2018; 120: 693-704
        • Takawira N.
        • Han R.J.
        • Nguyen T.Q.
        • Gaines J.D.
        • Han T.H.
        Spinal cord stimulator and epidural haematoma.
        Br J Anaesth. 2012; 109: 649-650
        • Buvanendran A.
        • Young A.C.
        Spinal epidural hematoma after spinal cord stimulator trial lead placement in a patient taking aspirin.
        Reg Anesth Pain Med. 2014; 39: 70-72
        • Harrison C.
        • Epton S.
        • Bojanic S.
        • Green A.L.
        • FitzGerald J.J.
        The efficacy and safety of dorsal root ganglion stimulation as a treatment for neuropathic pain: a literature review.
        Neuromodulation. 2018; 21: 225-233
        • D'Souza R.S.
        • D'Souza S.
        • Sharpe E.E.
        YouTube as a source of medical information about epidural analgesia for labor pain.
        Int J Obstet Anesth. 2021; 45: 133-137
        • Langford B.
        • Hooten W.M.
        • D'Souza S.
        • Moeschler S.
        • D'Souza R.S.
        YouTube as a source of medical information about spinal cord stimulation.
        Neuromodulation. 2021; 24: 156-161
        • Dowell D.
        • Ragan K.
        • Jones C.
        • Baldwin G.
        • Chou R.
        CDC Clinical Practice Guideline for Prescribing Opioids-United States.
        Centers for Disease Control and Prevention, 2022