Rafik Sedra, an advanced pain trainee from Oxford school of anaesthesia, and Dr Pradeep Desai, chronic pain consultant at Wexham Park Hospital, discuss their research – a retrospective study and case series about epiduroplasty
Background: Chronic lower back pain (LBP) and radicular pain following failed back surgery and spinal canal stenosis is not uncommon. Percutaneous epidural adhesiolysis with hypertonic saline as a three-day or one-day procedure has been established (8). We present retrospective cases using normal saline as one-day protocol.
Objectives: To retrospectively assess the efficacy of one-day epiduroplasty using normal saline instead of hypertonic saline to improve pain, function and quality of life (QOL) in patients with failed back surgery syndrome (FBSS) and spinal stenosis.
Method: Retrospective data collection.
Results: Our study shows the range of duration of pain control is between one month and 48 months, with improvement of quality of life and function.
Conclusion: One-day protocol epiduroplasty using normal saline can be an effective and safe procedure for patients of FBSS and spinal canal stenosis with lower back pain (LBP) and radicular leg pain.
Limitation: Non-randomised, non-blinded, retrospective small study.
Chronic back and leg pain is triggered from various structures in the spine. The pain generators can be intervertebral discs, nerve roots, dura, facet joints, ligaments, fascia and muscles as tissues capable of transmitting pain in the low back and lower extremity (7,8). The aetiology and pathophysiology of LBP and radicular pain has been comprehensively discussed in literature such as vascular compromise, inflammation, biochemical influences, post lumbar laminectomy syndrome, spinal stenosis and disc herniation or compression (13). The painful symptoms in “failed back surgery syndrome” (FBSS) following surgical spinal procedures can happen in up to 40 per cent of patients (1). Among post lumbar laminectomy syndrome patients, epidural fibrosis is seen in approximately 60 per cent of the patients with recurring symptoms, along with instability (12). Epidural fibrosis may develop as well without surgical intervention, secondary to annular tear, hematoma and infection (1,12).
There are two systematic reviews showing that in patients with previous back surgery, fluoroscopically-guided epidural (caudal/lumbar, translaminar or transforaminal) steroid injection will spread to reach the level of pathology in only 26 per cent of cases. The inability to reach and effectively spread to the affected nerve roots is considered to be due to the surrounding adhesions (2).
The hypothesis of the current study was that the targeted epidural medication delivery near the desired nerve root after adhesiolysis may result in better pain relief using normal saline as a one-day protocol. The goal of the current study was to look for improvement in pain scores, level of function improvement and quality of life change using the global pain assessment scoring system explained by John T Farrar (6). In our study we compare the outcomes where we used normal saline for epiduroplasty as one-day procedure versus three days protocol where hypertonic saline been used.
In this case study we present 32patients whounderwent caudal epiduroplasty. 29 patients with a diagnosis of FBSS and three cases with spinal canal stenosis. The study was conducted over 32, months between January 2017 and September 2019. We used the global assessment of pain, which includes the quality of pain control, quality of life change and functional improvement following epiduroplasty. The global assessment is used, as suggested by John T Farrar, as it can combine multiple important outcomes, it allows patients to integrate factors and answers important clinical questions. The scale is explained as change expressed in the following terms; much worse, worse, a little worse, no change, a little better, better, much better.
Patients were consented and received an information leaflet prior to the procedure. All patients were discussed in multidisciplinary team meetings with spinal surgeons, radiologists and physiotherapists. The patients considered suitable for psychology input also received one-to-one psychology support.
Inclusion and exclusion criteria
Inclusion criteria – Patients aged between 18 and 85 years, with a history of chronic low back pain and/or lower extremity pain of at least 6 months and have shown an absence of facet joint pain by controlled comparative local anaesthetic blocks or facet joint injections. They also had failed to respond to other conservative treatment including fluoroscopically guided epidural injections.
Exclusion criteria – Large contained or sequestered herniation, cauda equina syndrome, compressive radiculopathy, drug addiction and uncontrolled major psychiatric disorders, local and global infections, coagulopathy and patients who are suitable for spinal surgery.
32 Patients were included in this study, 20 female and 12 males, age group between 37– 86 years.
All patients were given sedation by an anaesthetist and had appropriate monitoring throughout the procedure. They received one dose of antibiotic at the beginning of sedation.
A 16 G RK needle (Epimed international) was introduced into the caudal epidural space guided by fluoroscopy. Once the needle placement was confirmed to be in the epidural space, an epidurogram was obtained, utilising contrast, Omnipaque 300. Then an RACZ -STF catheter was advanced via the caudal epidural space to appropriate target level and spread of contrast viewed for filling defects. The RACZ catheter was advanced to the areas where the suspected adhesions were to be targeted at the filling defect areas.
Normal saline was pushed through the catheter 2ml to 5ml each time at levels of adhesions to about 20-25ml total followed by hyaluronidase 1500 I.U. diluted to 5ml with normal saline. Contrast was injected again to check improved spread afterwards, identified by nerve root filling as well as ventral and lateral epidural filling. If it appeared that the catheter was not advancing in spite of multiple gentle pushing, no force was applied. Also if there appeared a kink at the catheter tip, the catheter was withdrawn and a fresh one inserted. Additionally, the absence of subdural, subarachnoid, and intravascular uptake of contrast was confirmed. Then Triamcinolone 80mg (after preservative aspirated and discarded) diluted with 5ml of normal saline was injected in the target area. The total volume of contrast Omnipaque 300 used was between 15-20ml. All patients transferred to recovery in supine position.
Postoperatively appropriate analgesia was prescribed for pain control in recovery. Most patients in this study were discharged home on the same day without any complications, except two patients who had significant pain immediately following the procedure, which was managed by appropriate analgesia. One patient stayed overnight for analgesia management.
Our study shows that duration of range of pain control is between one month and a maximum of 48 months. Seven patients had repeat injections. The average interval for repeat injections was 5.16 months (minimum three months and maximum nine months). In terms of quality of pain control; 42 per cent of patients felt much better, 37 per cent better, 12 per cent a little better, no change for 6 per cent and a little worse for 3 per cent. Quality of life improvement reported by patients where 52 per cent reported as better, 37 per cent much better, 1 per cent little better, no change for 7 per cent and 3 per cent a little worse. Improvement of function described by patients as 55 per cent better, 31 per cent much better while 1 per cent little better, 7 per cent showed no change and a little worse in 6 per cent.
FBSS is a poorly defined, heterogeneous disorder with surgical and nonsurgical pathologies when patients fail to improve after back surgery (2). Adhesions surrounding nerve roots may interfere with their nutrition and blood supply and are likely contributors to radicular pain. Impairment of blood flow to the neural structures is probably the final common pathway leading to abnormalities in nerve conduction and pain generation (1).
It is postulated that epiduroplasty may allow room for the restoration of blood supply and nerve root nutrition, resulting in improvement of nerve dysfunction and pain relief (8). In our study we used one-day protocol versus the standard three days RACZ procedure. This avoids the potential for introducing infection due to longer siting of catheter in caudal epidural space and repeated injections (4). Also a longer hospital stay increased the risk of hospital-acquired infections, deep venous thrombosis and more demand on precious hospital resources. In our study we used normal saline instead of hypertonic saline used in standard RACZ procedure, this was to avoid potential complications of hypertonic saline such as severe pain during injection, paresthesia, and chemical arachnoiditis and also lack of ready availability of hypertonic saline (5,9-11). Normal saline is readily available and has no significant risks.
Racz et al and Haevner et al reported the percentage of patients receiving pain relief for 1-4 weeks is 83 per cent, while 49 per cent got relief for three months, 43 per cent for six months and 49 per cent for one year. While Manchikanti et al reported results for one-day procedure adhesionlysis using hypertonic saline as 72 per cent of patients showing improvement in pain scores (a reduction of more than 50 per cent) at three, six and 12 months. Manchikanti et al reported results of adhesiolysis using normal saline (one-day procedure) after three, six and 12 month as 64 per cent, 60 per cent and 60 per cent of patients consecutively got a reduction of pain by >50 per cent (8).
Epiduroplasty using normal saline as a one-day procedure shows encouraging results in improvement of pain scores (between one month and 48 months), quality of life and function.
In our study the main postoperative complication was temporary worsening of pain immediately after the procedure, which was managed with appropriate analgesia. From our small retrospective study we can conclude that epiduroplasty using normal saline rather than hypertonic saline can achieve acceptable pain relief.
Epidural adhesiolysis used to treat chronic LBP by eliminating fibrous tissues from the epidural space. There is fairly good evidence that it is a safe and effective intervention in relieving low back and leg pain.It is recommended to be used not as initial treatment but after simple procedures have failed.Our results show that epiduroplasty using normal saline, hyaluronidase, triamcinolone is an effective treatment for chronic low back and leg pain (especially for FBSS) that failed to respond to other measures.
This is just to confirm there are no conflicts of interest
regarding our study.
- Anderson SR. A rationale for the treat- ment algorithm of failed back surgery syn- drome. Curr Rev Pain 2000; 4:395-406.
- Bosscher H., Heavner J. Incidence and severity of epidural fibrosis after back surgery: an endoscopic study, Pain Practice 2010;10:18—24
- Bressler HB, Keyes WJ, Rochon PA et al. The prevalence of low back pain in the el- derly. A systemic review of the literature. Spine 1999; 24:1813-1819
- El Molla A, epiduroplasty in failed back surgery syndrome with and without epiduroscope, a randomized control trial, The Journal of scientific articles “Health and Education Millennium”, 2016. Vol. 18. No 7.
- Isao Aoi, Huan-Chieh Chen, Tai-Ngar Lui1 and Tien-Jen Lin. Outcomes of Epidural Neuroplasty Utilizing adhesiolysis by Means of Hydraulic and Mechanical force. Journal of biomedicine. 2018; 3: 26
- John T Farrar, Global assessment of pain symptoms presentation.
- Lawrence RC, Helmick CG, Arnett FC. Es- timates of the prevalence of arthritis and selected musculoskeletal disorders in the United States. Arthritis Rheum 1998; 41: 778-799.
- Manchikanti L, Rivera JJ, Pampati V, et al. one day lumbar epidural adhesiolysis and hypertonic saline neurolysis in treatment of chronic low back pain: a randomized, double-blind trial. Pain Physician, 2004; 7(2): 177–86.
- Manchikanti L, Pampati V, Fellows B, Rivera JJ, Beyer CD, and Damron KS, “Role of one day epidural adhesiolysis in management of chronic low back pain: A randomized clinical trial”. Pain Physician. 2001; 4(2):153-166.
- Manchikanti L, Pakanati R, Bakhit CE, and Pampati V, “Role of adhesiolysis and hypertonic saline neurolysis in management of low back pain: evaluation of modification of the Racz protocol”. Pain Digest. 1999; 9(9): 91-96.
- Manchikanti L, Pampati V, Bakhit CE, Pakanati RR. “Non-endoscopic and endoscopic adhesiolysis in post-lumbar laminectomy syndrome: a one-year outcome study and cost effectiveness analysis”. Pain Physician. 1999; 2(3): 52-58.
- Phillips FM, Cunningham B. Managing chronic pain of spinal origin after lumbar surgery. Spine 2002; 27:2547-2553.
- Wheeler AH, Murrey DB. Chronic lumbar spine and radicular pain: Pathophysiolo- gy and treatment. Curr Pain Headache Rep 2002; 6:97-105.1999; 2(3): 52-58.