scholarly journals The Intrathecal Morphine for Percutaneous Endoscopic Lumbar Discectomy (IMPELD) Study: Rationale and Protocol for a Double-blinded Randomized Placebo-controlled Trial

Author(s):  
Yue Lei ◽  
Zhang Feng ◽  
Mu Guanzhang ◽  
Shang Meixia ◽  
Sun Haolin ◽  
...  

AbstractBackgroundPercutaneous endoscopic lumbar discectomy (PELD), a minimally invasive spinal technique for lumbar disc herniation (LDH), has gained popularity globally and yielded satisfying results. However, PELD is often performed on awaking patients to avoid nerve injury, thus the intraoperative analgesia of PELD is sometimes insufficient. The effect of intrathecal morphine (ITM) has been well proved in various surgical specialties, and this study aims to investigate the effectiveness and safety of ITM on PELD.MethodsThe intrathecal morphine for percutaneous endoscopic lumbar discectomy (IMPELD) trial is a double-blind, randomized, placebo-controlled trial. The 90 eligible LDH patients undergoing PELD will be randomly assigned to receive either ITM or placebo during spinal anesthesia, at a 1:1 ratio, with a one-month follow-up period. Average intraoperative pain intensity will be the primary outcome. Secondary outcome measures include intraoperative pain intensity assessed at each 30 min intraoperatively, postoperative pain intensity, perioperative analgesia requirements, functional evaluation, radiographic characteristics, overall satisfaction, other characteristics and adverse events.DiscussionCurrently, there is a lack of scientific evidence to provide a reliable method to reduce intraoperative pain of PELD. The IMPELD trial was designed to provide evidence regarding whether 100 ug of ITM is an effective and safe coanalgesic approach for PELD procedure.Trial registrationThe trial was registered with the Chinese Clinical Trial Registry (identifier ChiCTR2000039842). Registered on November 11th, 2020.

2021 ◽  
Vol 103-B (8) ◽  
pp. 1392-1399
Author(s):  
Tae Wook Kang ◽  
Si Young Park ◽  
Hoonji Oh ◽  
Soon Hyuck Lee ◽  
Jong Hoon Park ◽  
...  

Aims Open discectomy (OD) is the standard operation for lumbar disc herniation (LDH). Percutaneous endoscopic lumbar discectomy (PELD), however, has shown similar outcomes to OD and there is increasing interest in this procedure. However despite improved surgical techniques and instrumentation, reoperation and infection rates continue and are reported to be between 6% and 24% and 0.7% and 16%, respectively. The objective of this study was to compare the rate of reoperation and infection within six months of patients being treated for LDH either by OD or PELD. Methods In this retrospective, nationwide cohort study, the Korean National Health Insurance database from 1 January 2007 to 31 December 2018 was reviewed. Data were extracted for patients who underwent OD or PELD for LDH without a history of having undergone either procedure during the preceding year. Individual patients were followed for six months through their encrypted unique resident registration number. The primary endpoints were rates of reoperation and infection during the follow-up period. Other risk factors for reoperation and infection were also evalulated. Results Out of 549,531 patients, 522,640 had undergone OD (95.11%) and 26,891 patients had undergone PELD (4.89%). Reoperation rates within six months were 2.28% in the OD group, and 5.38% in the PELD group. Infection rates were 1.18% in OD group and 0.83% in PELD group. The risk of reoperation was lower for patients with OD than for patients with PELD (adjusted hazard ratio (HR) 0.38). The risk of infection was higher for patients with OD than for patients undergoing PELD (HR, 1.325). Conclusion Compared with the OD group, the PELD group showed higher reoperation rates and lower infection rates. Cite this article: Bone Joint J 2021;103-B(8):1392–1399.


2018 ◽  
Vol 2018 ◽  
pp. 1-8 ◽  
Author(s):  
Manyoung Kim ◽  
Sol Lee ◽  
Hyeun-Sung Kim ◽  
Sangyoon Park ◽  
Sang-Yeup Shim ◽  
...  

Background. Among the surgical methods for lumbar disc herniation, open lumbar microdiscectomy is considered the gold standard. Recently, percutaneous endoscopic lumbar discectomy is also commonly performed for lumbar disc herniation for its various strong points. Objectives. The present study aims to examine whether percutaneous endoscopic lumbar discectomy and open lumbar microdiscectomy show better results as surgical treatments for lumbar disc herniation in the Korean population. Methods. In the present meta-analysis, papers on Korean patients who underwent open lumbar microdiscectomy and percutaneous endoscopic lumbar discectomy were searched, both of which are surgical methods to treat lumbar disc herniation. The papers from 1973, when percutaneous endoscopic lumbar discectomy was first introduced, to March 2018 were searched at the databases of MEDLINE, EMBASE, PubMed, and Cochrane Library. Results. Seven papers with 1254 patients were selected. A comparison study revealed that percutaneous endoscopic lumbar discectomy had significantly better results than open lumbar microdiscectomy in the visual analogue pain scale at the final follow-up (leg: mean difference [MD]=-0.35; 95% confidence interval [CI]=-0.61, -0.09; p=0.009; back: MD=-0.79; 95% confidence interval [CI]=-1.42, -0.17; p=0.01), Oswestry Disability Index (MD=-2.12; 95% CI=-4.25, 0.01; p=0.05), operation time (MD=-23.06; 95% CI=-32.42, -13.70; p<0.00001), and hospital stay (MD=-4.64; 95% CI=-6.37, -2.90; p<0.00001). There were no statistical differences in the MacNab classification (odds ratio [OR]=1.02; 95% CI=0.71, 1.49; p=0.90), complication rate (OR=0.72; 95% CI=0.20, 2.62; p=0.62), recurrence rate (OR=0.83; 95% CI=0.50, 1.38; p=0.47), and reoperation rate (OR=1.45; 95% CI=0.89, 2.35; p=0.13). Limitations. All 7 papers used for the meta-analysis were non-RCTs. Some differences (type of surgery (primary or revisional), treatment options before the operation, follow-up period, etc.) existed depending on the selected paper, and the sample size was small as well. Conclusion. While percutaneous endoscopic lumbar discectomy showed better results than open lumbar microdiscectomy in some items, open lumbar microdiscectomy still showed good clinical results, and it is therefore reckoned that a randomized controlled trial with a large sample size would be required in the future to compare these two surgical methods.


2020 ◽  
Author(s):  
Lei Kong ◽  
Wei-Zhi Zhang ◽  
Hong-Guang Xu

Abstract Background: Minimally invasive surgery includes percutaneous endoscopic lumbar discectomy and the microscopic tubular technique. This study aimed to compare the two techniques and evaluate the outcomes of the procedures.Methods: We retrospectively analyzed patients with far-lateral lumbar disc herniation (FLLDH) from June 2015 to October 2018. Twenty-six patients underwent paraspinal muscle-splitting microscopic-assisted discectomy (MD) and 30 patients underwent percutaneous endoscopic lumbar discectomy (PELD) surgery by the same surgical team. Data included the duration of the operation, duration of intraoperative radiation exposure, and average duration of hospitalization. Pre- and postoperative pain scores and neurological functions were recorded using a visual analog scale (VAS) score and Oswestry disability index (ODI).Results: 56 patients remained in the study over the 12–24 months period. The mean operating time was 65.83 ± 16.64 min in the PELD group, mean duration of radiation exposure was 2.87 ± 1.19 min, and average of hospitalization was 3.43 days. The mean operating time was 44.96 ± 16.87 min in the MD group, duration of radiation exposure was 0.78 ± 0.32 min, and duration of hospitalization was 4.12 days. There were two patients with postoperative transient dysesthesia and one underwent reoperation 7 months after surgery in the PELD group. One patient had postoperative transient dysesthesia in the MD group. Except low back pain at 3 months (p >0.05), all patients in both groups showed significant improvement in VAS and ODI scores compared with pre-operation and until final follow-up (p<0.05). Although the learning curve of MD is shorter compared with the PELD, beginners should practice on cadavers and receive teaching demonstrations from senior surgeons.Conclusion: Both techniques are minimally invasive, effective, and safe for treating far-lateral lumbar disc herniation in selected patients. Compared with the PELD technique, the MD procedure offers a wider field of vision during operation, shorter operation time, fewer postoperative complications, and shorter learning curve.


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