Korean J Pain.  2019 Jul;32(3):196-205. 10.3344/kjp.2019.32.3.196.

Effectiveness of continuous hypertonic saline infusion with an automated infusion pump for decompressive neuroplasty: a randomized clinical trial

• Lee HJ
• Lee J
• Park YW
• Gil HY
• Choi E
• Nahm FS
• Lee PB

• KMID: 2455615
• DOI: http://doi.org/10.3344/kjp.2019.32.3.196

Abstract

BACKGROUND
Hypertonic saline (HS) injections for decompressive neuroplasty (DN) can cause pain. We assessed whether a continuous infusion of HS through an infusion pump would reduce injection-related pain compared with repeated bolus administrations.
METHODS
Fifty patients scheduled for DN were randomized to either the bolus injection or the continuous infusion group. After appropriately placing the epidural catheter, 4 mL of 5% NaCl was injected as four boluses of 1 mL each at 15-minute intervals or infused over 1 hour using an infusion pump. The severity of pain induced by HS injection, as measured by the 11-point numerical rating scale (NRS), was the primary outcome. The severity of low back or lower extremity pain, as measured by the 11-point NRS and Oswestry Disability Index (ODI), 3 months following the procedure, was the secondary outcome.
RESULTS
Data from 21 patients in the bolus group and 23 in the continuous infusion group were analyzed. No statistically significant difference in injection-related pain was identified between the two groups during the initial HS administration (P = 0.846). However, there was a statistically significant reduction in injection-related pain in the continuous infusion group compared to the bolus injection group from the second assessment onwards (P = 0.001, < 0.001, and < 0.001, respectively). No significant between-group differences in the NRS and ODI scores 3 months post-procedure were noted (P = 0.614 and 0.949, respectively).
CONCLUSIONS
Our study suggests that administering HS through a continuous infusion is a useful modality for reducing HS injection-related pain during DN.

Keyword

Chronic Pain; Infusion Pumps; Injections, Epidural; Low Back Pain; Pain, Procedural; Radiculopathy; Saline Solutions, Hypertonic; Spinal Stenosis

MeSH Terms

Catheters
Chronic Pain
Humans
Infusion Pumps*
Injections, Epidural
Low Back Pain
Lower Extremity
Radiculopathy
Saline Solution, Hypertonic
Spinal Stenosis
Saline Solution, Hypertonic

Figure

• 

  Fig. 1 Flow diagram of patients in this study. At 3 months post-procedure, 21 and 23 patients remained in each arm, respectively.

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  Fig. 2 The 11-point numeric rating scale (NRS) scores (0 = no pain, 10 = unbearable pain) of injection-related pain induced by hypertonic saline infusion. Data are shown in a box plot with the 95% confidence intervals (whiskers). aSignificant at P < 0.05, compared to the 1st injection NRS. bSignificant at P < 0.05, compared to the 2nd injection NRS.

• 

  Fig. 3 The 11-point numeric rating scale (NRS) scores (0 = no pain, 10 = unbearable pain) for the leg and lower back pain in patients receiving lumbar epidural adhesiolysis. Data are shown in a box plot with the 95% confidence intervals (whiskers). aSignificant at P < 0.05, compared to the baseline NRS.

• 

  Fig. 4 Oswestry Disability Index (ODI) scores in patients receiving lumbar epidural adhesiolysis. Data are shown in a box plot with the 95% confidence intervals (whiskers). aSignificant at P < 0.05, compared to the baseline ODI.

Reference

1. Lee F, Jamison DE, Hurley RW, Cohen SP. Epidural lysis of adhesions. Korean J Pain. 2014; 27:3–15. DOI: 10.3344/kjp.2014.27.1.3. PMID: 24478895. PMCID: 3903797.

2. Ross JS, Robertson JT, Frederickson RC, Petrie JL, Obuchowski N, Modic MT, et al. Association between peridural scar and recurrent radicular pain after lumbar discectomy: magnetic resonance evaluation. ADCON-L European Study Group. Neurosurgery. 1996; 38:855–61. DOI: 10.1227/00006123-199604000-00053. PMID: 8692415.

3. Igarashi T, Hirabayashi Y, Seo N, Saitoh K, Fukuda H, Suzuki H. Lysis of adhesions and epidural injection of steroid/local anaesthetic during epiduroscopy potentially alleviate low back and leg pain in elderly patients with lumbar spinal stenosis. Br J Anaesth. 2004; 93:181–7. DOI: 10.1093/bja/aeh201. PMID: 15194631.

4. Robertson JT. Role of peridural fibrosis in the failed back: a review. Eur Spine J. 1996; 5(Suppl 1):S2–6. DOI: 10.1007/BF00298565. PMID: 8915643.

5. Trescot AM, Chopra P, Abdi S, Datta S, Schultz DM. Systematic review of effectiveness and complications of adhesiolysis in the management of chronic spinal pain: an update. Pain Physician. 2007; 10:129–46. PMID: 17256027.

6. Racz GB, Heavner JE, Trescot A. Percutaneous lysis of epidural adhesions--evidence for safety and efficacy. Pain Pract. 2008; 8:277–86. DOI: 10.1111/j.1533-2500.2008.00203.x. PMID: 18503627.

7. Helm Ii S, Benyamin RM, Chopra P, Deer TR, Justiz R. Percutaneous adhesiolysis in the management of chronic low back pain in post lumbar surgery syndrome and spinal stenosis: a systematic review. Pain Physician. 2012; 15:E435–62. PMID: 22828693.

8. Waldman SD. Atlas of interventional pain management. 4th ed. Philadelphia: Elsevier Saunders;2014. p. 568–76.

9. Birkenmaier C, Redeker J, Sievers B, Melcher C, Jansson V, Mayer-Wagner S. An evaluation of medications commonly used for epidural neurolysis procedures in a human fibroblast cell culture model. Reg Anesth Pain Med. 2011; 36:140–4. DOI: 10.1097/AAP.0b013e31820d41c4. PMID: 21270726.

10. Manchikanti L, Rivera JJ, Pampati V, Damron KS, McManus CD, Brandon DE, 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; 7:177–86. PMID: 16868590.

11. Erdine S, Talu GK. Precautions during epidural neuroplasty. Pain Pract. 2002; 2:308–14. DOI: 10.1046/j.1533-2500.2002.02038.x. PMID: 17156038.

12. Baraniuk JN, Ali M, Yuta A, Fang SY, Naranch K. Hypertonic saline nasal provocation stimulates nociceptive nerves, substance P release, and glandular mucous exocytosis in normal humans. Am J Respir Crit Care Med. 1999; 160:655–62. DOI: 10.1164/ajrccm.160.2.9805081. PMID: 10430743.

13. Leffler AS, Kosek E, Hansson P. Injection of hypertonic saline into musculus infraspinatus resulted in referred pain and sensory disturbances in the ipsilateral upper arm. Eur J Pain. 2000; 4:73–82. DOI: 10.1053/eujp.1999.0160. PMID: 10833557.

14. Bennell K, Hodges P, Mellor R, Bexander C, Souvlis T. The nature of anterior knee pain following injection of hypertonic saline into the infrapatellar fat pad. J Orthop Res. 2004; 22:116–21. DOI: 10.1016/S0736-0266(03)00162-1. PMID: 14656669.

15. Choi EJ, Yoo YJ, Lee PB, Kim YC, Lee SC, Moon JY. A retrospective study to evaluate the effect of concentration of hypertonic saline on efficacy and safety of epidural adhesiolysis. Anesth Analg. 2017; 124:2021–9. DOI: 10.1213/ANE.0000000000001925. PMID: 28448392.

16. Jankovic D, Peng P. Regional nerve blocks in anesthesia and pain therapy: traditional and ultrasound-guided techniques. Cham: Springer;2015. p. 655–70.

17. Kim J, Shin W. How to do random allocation (randomization). Clin Orthop Surg. 2014; 6:103–9. DOI: 10.4055/cios.2014.6.1.103. PMID: 24605197. PMCID: 3942596.

18. Kim JH, Jung HJ, Nahm FS, Lee PB. Does improvement in epidurography following percutaneous epidural neuroplasty correspond to patient outcome? Pain Pract. 2015; 15:407–13. DOI: 10.1111/papr.12197. PMID: 24750546.

19. H Seo. J Yoo. Piezo-electric actuated infusion pump. Korea patents. KR101127126B1. 2012. Mar. 21.

20. Scarfone RJ, Jasani M, Gracely EJ. Pain of local anesthetics: rate of administration and buffering. Ann Emerg Med. 1998; 31:36–40. DOI: 10.1016/S0196-0644(98)70278-1. PMID: 9437339.

21. Cardoso MM, Carvalho JC. Epidural pressures and spread of 2% lidocaine in the epidural space: influence of volume and speed of injection of the local anesthetic solution. Reg Anesth Pain Med. 1998; 23:14–9. PMID: 9552773.

22. Son WG, Jang M, Yoon J, Lee LY, Lee I. The effect of epidural injection speed on epidural pressure and distribution of solution in anesthetized dogs. Vet Anaesth Analg. 2014; 41:526–33. DOI: 10.1111/vaa.12147. PMID: 24628876.

23. Usubiaga JE, Wikinski JA, Usubiaga LE. Epidural pressure and its relation to spread of anesthetic solutions in epidural space. Anesth Analg. 1967; 46:440–6. DOI: 10.1213/00000539-196707000-00017. PMID: 4952222.

24. Ho KY, Manghnani P. Acute monoplegia after lysis of epidural adhesions: a case report. Pain Pract. 2008; 8:404–7. DOI: 10.1111/j.1533-2500.2008.00229.x. PMID: 18721177.

25. Graven-Nielsen T, Arendt-Nielsen L, Svensson P, Jensen TS. Quantification of local and referred muscle pain in humans after sequential i.m. injections of hypertonic saline. Pain. 1997; 69:111–7. DOI: 10.1016/S0304-3959(96)03243-5. PMID: 9060020.

26. Lee JH, Lee SH. Clinical effectiveness of percutaneous adhesiolysis using Navicath for the management of chronic pain due to lumbosacral disc herniation. Pain Physician. 2012; 15:213–21. PMID: 22622905.