scholarly journals Challenges in the Analysis of Longitudinal Pain Data: Practical Lessons from a Randomized Trial of Annular Closure in Lumbar Disc Surgery

2019 ◽  
Vol 2019 ◽  
pp. 1-6
Author(s):  
Gerrit J. Bouma ◽  
Martin Barth ◽  
Larry E. Miller ◽  
Sandro Eustacchio ◽  
Charlotte Flüh ◽  
...  

Purpose. To analyze leg pain severity data from a randomized controlled trial (RCT) of lumbar disc surgery using integrated approaches that adjust pain scores collected at scheduled follow-up visits for confounding clinical events occurring between visits. Methods. Data were derived from an RCT of a bone-anchored annular closure device (ACD) following lumbar discectomy versus lumbar discectomy alone (Control) in patients with large postsurgical annular defects. Leg pain was recorded on a 0 to 100 scale at 6 weeks, 3 months, 6 months, 1 year, and 2 years of follow-up. Patients with pain reduction ≥20 points relative to baseline were considered responders. Unadjusted analyses utilized pain scores reported at follow-up visits. Since symptomatic reherniation signifies clinical failure of lumbar discectomy, integrated analyses adjusted pain scores following a symptomatic reherniation by baseline observation carried forward for continuous data or classification as nonresponders for categorical data. Results. Among 550 patients (272 ACD, 278 Control), symptomatic reherniation occurred in 10.3% of ACD patients and in 21.9% of controls (p < 0.001) through 2 years. There was no difference in leg pain scores at the 2-year visit between ACD and controls (12 versus 14; p = 0.33) in unadjusted analyses, but statistically significant differences favoring ACD (19 versus 29; p < 0.001) in integrated analyses. Unadjusted nonresponder rates were 6.0% with ACD and 6.7% with controls (p = 0.89), but 15.7% and 27.8% (p = 0.001) in integrated analyses. The probability of nonresponse was 16.4% with ACD and 18.3% with controls (p = 0.51) in unadjusted analysis, and 23.7% and 31.2% (p = 0.04) in integrated analyses. Conclusion. In an RCT of lumbar disc surgery, an integrated analysis of pain severity that adjusted for the confounding effects of clinical failures occurring between follow-up visits resulted in different conclusions compared to an unadjusted analysis of pain scores reported at follow-up visits only.

2016 ◽  
Vol 2016 ◽  
pp. 1-5 ◽  
Author(s):  
Melek Demiroglu ◽  
Canan Ün ◽  
Dilsen Hatice Ornek ◽  
Oya Kıcı ◽  
Ali Erdem Yıldırım ◽  
...  

Aim.To investigate the effect of magnesium administered to the operative region muscle and administered systemically on postoperative analgesia consumption after lumbar disc surgery.Material and Method.The study included a total of 75 ASA I-II patients aged 18–65 years. The patients were randomly allocated into 1 of 3 groups of 25: the Intravenous (IV) Group, the Intramuscular (IM) Group, and the Control (C) Group. At the stage of suturing the surgical incision site, the IV Group received 50 mg/kg MgSO4intravenously in 150 mL saline within 30 mins. In the IM Group, 50 mg/kg MgSO4in 30 mL saline was injected intramuscularly into the paraspinal muscles. In Group C, 30 mL saline was injected intramuscularly into the paraspinal muscles. After operation patients in all 3 groups were given 100 mg tramadol and 10 mg metoclopramide and tramadol solution was started intravenously through a patient-controlled analgesia device. Hemodynamic changes, demographic data, duration of anesthesia and surgery, pain scores (NRS), the Ramsay sedation score (RSS), the amount of analgesia consumed, nausea- vomiting, and potential side effects were recorded.Results.No difference was observed between the groups. Nausea and vomiting side effects occurred at a rate of 36% in Group C, which was a significantly higher rate compared to the other groups (p<0.05). Tramadol consumption in the IM Group was found to be significantly lower than in the other groups (p<0.05).Conclusion.Magnesium applied to the operative region was found to be more effective on postoperative analgesia than systemically administered magnesium.


2021 ◽  
Author(s):  
Hai-Chao He ◽  
Xiao-qiang LV ◽  
Yong-Jin Zhang

Abstract Background In recent decades, endoscopic techniques to treat lumbar disc herniation (LDH) have gained popularity in clinical practice. However, there is little literature on the use of percutaneous endoscopic lumbar discectomy (PELD) to treat cauda equina syndrome (CES) due to LDH. This study aims to evaluate the feasibility and clinical efficacy of PELD for treating CES caused by disc herniation, and as well as to report some technical strategies. Methods Between October 2012 and April 2018, 15 patients with CES caused by LDH at the early and intermediate stages of Shi’s classification were selected as the subjects of study, and underwent PELD. All patients were followed up for at least two years. The patients’ back pain and leg pain were evaluated using visual analogue scale (VAS) scores and the Oswestry Disability Index (ODI). Patient satisfaction was evaluated using the MacNab outcome scale. Clinical outcomes were measured preoperatively and at 3 days, 3 months, 6 months and the last follow-up. Results The VAS score for back pain, leg pain and ODI score significantly decreased from preoperatively scores of 6.67 ± 1.05, 7.13 ± 1.19 and 62.0 ± 6.85 respectively, to postoperatively cores of 1.80 ± 0.41, 1.47 ± 0.52 and 12.93 ± 1.03 at the last follow-up postoperatively. These postoperative scores were all significantly different compared with preoperative scores (P < 0.01). According to the modified MacNab outcome scale, 86.67% of these patients had excellent and good outcomes at the final follow-up. Complications included one patient with cerebrospinal fluid leakage and one patient who developed recurrent herniation; the latter patient finally achieved satisfactory results after reoperation. Conclusion PELD could be used as an alternative surgical method for the treatment of CES due to LDH in properly selected cases and appropriate patient selection. However, the operator should pay attention to foraminoplasty to enlarge the working space.


2016 ◽  
Vol 10 (1) ◽  
pp. 85-89 ◽  
Author(s):  
Voitto Järvimäki ◽  
Hannu Kautiainen ◽  
Maija Haanpää ◽  
Seppo Alahuhta ◽  
Merja Vakkala

ABSTRACTPurposeTo investigate the effect of obesity on outcome in lumbar discectomy.MethodsA cross-sectional postal survey; a self-made questionnaire, Beck depression inventory IA (BDI IA) and the Oswestry low back disability questionnaire (ODI) were sent to the patients, who had undergone lumbar disc surgery in the Oulu University Hospital between June 2005 and May 2008. Patients were divided into three groups according to BMI: normal, pre-obese and obese. The ODI was also examined in the framework of the international classification of functioning, disability and health (ICF) to investigate its ability to describe various dimensions of functioning (body structure and functions, activities and participation).Results The postal survey was sent to 642 patients, of whom 355 (55%) replied. Males dominated in the pre-obese (66%) and obese (62%) groups (p = 0.01). Normal-weighted and pre-obese patients had lower BDI scores compared to obese patients (mean BDI: 8.0, 7.6,11.2, respectively, p = 0.035). Total ODI score was highest in the obese group compared to normal-weighted or pre-obese (20.3,18.6,26.4, respectively, p = 0.011). When ODI was linked to the ICF there were significant differences in all activity domains (mobility, self-care and interpersonal interactions and relationships) and the mobility component of the participation domain between the weight groups.Conclusions and implicationsObesity has an impact on outcome in lumbar discectomy. Obese patients had higher scores in BDI and ODI indicating mild mood disturbances and moderate functional disability. According to ICF, functional disability of obese patients was observed to some extent in all activity domains. Obese patients will be more frequently present for disc surgery and increased morbidity risk must be recognized. We need a strategy to rehabilitate and activate obese patients pre- and postoperatively.


Neurosurgery ◽  
1991 ◽  
Vol 29 (2) ◽  
pp. 301-308 ◽  
Author(s):  
Joel N. Abramovitz ◽  
Samuel R. Neff

Abstract The Prospective Lumbar Discectomy Study enrolled 740 patients in a multiphysician, multicenter, consecutive patient protocol to evaluate the indications and efficacy of lumbar discectomy. Five hundred and thirteen patients could be evaluated at 3 months after surgery. Stepwise logistic regression showed that the factors of fraction of pain referred to the back, work-related injury, absence of back pain on straight leg-raise examination, correspondence of leg pain to typical radicular patterns, leg pain on straight leg-raise examination, and reflex asymmetry were independently predictive of good outcome from surgery. Univariate analysis of the cases with different numbers of predictive factors present showed that use of the operating microscope, sensory deficit, central disc bulge, and free disc fragment were correlated with outcome only in subgroups. An analysis of unsatisfactory outcomes showed two patterns: one of failure as a result of mechanical back pain and one of failure as a result of radiculopathy. Factors predictive of outcome did not influence the type of failure, In a stepwise logistic regression analysis, facetectomy and preoperative sensory deficit were associated with increased likelihood of mechanical back pain failure, while preoperative motor deficit was associated with an increased likelihood of radicular failure. The results support several intuitively derived and commonly believed principles of lumbar disc surgery.


2020 ◽  
Vol 2;23 (4;2) ◽  
pp. E211-E218
Author(s):  
Ding-Jun Hao

Background: Percutaneous endoscopic lumbar discectomy (PELD) can only relieve mechanical compression but cannot directly reduce the inflammatory reaction of the adjacent nerve root, which contributes to persistent pain and physical disabilities postoperatively. Numerous studies have explored the application of epidural steroids after an open lumbar discectomy in relieving pain by reducing local inflammatory reactions and further peridural scar formation. Objectives: To explore that whether “cocktail treatment” in which a gelatin sponge was impregnated with ropivacaine, dexamethasone, and vitamin B12 promoted early postoperative recovery after PELD. Study Design: Retrospective, case-controlled study. Setting: All data were from Hong-Hui Hospital in Xi’an. Methods: Between January 2016 and January 2017, 100 patients of single-level lumbar disc herniation were treated with PELD in our hospitals. The cocktail treatment was applied in the first 50 patients (group cocktail), and an equal size gelatin sponge without drugs was used in the other 50 patients as control (group noncocktail). The clinical outcome evaluation included the Visual Analog Scale (VAS) score for back and leg pain and Oswestry Disability Index (ODI) score. Results: There was a significant difference in the mean periods of return to work (4.25 ± 1.88 weeks in the cocktail group and 5.18 ± 2.19 weeks in the noncocktail group) (P < 0.01). Compared with the preoperative data, a significant improvement in VAS scores of back pain and sciatica and ODI were observed in each follow-up interval (P < 0.05, respectively). In the noncocktail group, there were visible fluctuations in the 3 indicators within the first week after surgery. This phenomenon was not observed in the cocktail group, a difference that was statistically significant (P < 0.05, respectively). In further follow-up, no significant differences were observed between the 2 groups (P > 0.05, respectively). Limitations: The nonrandomized, single-center, retrospective design is a major limitation of this study. Conclusions: The “cocktail treatment” with a gelatin sponge impregnated with ropivacaine, dexamethasone, and vitamin B12 promotes early and satisfactory back and leg pain relief and fast functional recovery after PELD. Key words: Endoscopic lumbar discectomy, lumbar disc herniation, steroids, nerve root block, gelatin sponge


1999 ◽  
Vol 13 (2) ◽  
pp. 178-184 ◽  
Author(s):  
V. GRAVER ◽  
A. K. HAALAND ◽  
B. MAGNAS ◽  
M. LOEB

Neurosurgery ◽  
2003 ◽  
Vol 53 (2) ◽  
pp. 331-337 ◽  
Author(s):  
Matthias Karst ◽  
Tanja Kegel ◽  
Anne Lukas ◽  
Wolf Lüdemann ◽  
Samii Hussein ◽  
...  

Abstract OBJECTIVE This study was designed to assess the efficacy of perioperative administration of celecoxib (Celebrex; Pharmacia GmbH, Erlangen, Germany) in reducing pain and opioid requirements after single-level lumbar microdiscectomy. METHODS We studied 34 patients (mean age, 44.26 yr; standard deviation [SD], 13.09 yr) allocated randomly to receive celecoxib 200 mg twice a day for 72 hours starting on the evening before surgery or placebo capsules in a double-blind study. Fourteen patients received 20 to 80 mg dexamethasone intravenously during surgery (mean, 40 mg; SD, 19.22 mg) because of visible signs of compression of the affected nerve root. After lumbar disc surgery, patients were monitored for visual analog scores for pain at rest and on movement, patient-controlled analgesia (PCA) piritramide requirements, and von Frey thresholds in the wound area. RESULTS Pain scores decreased and wound von Frey thresholds increased continuously until discharge, with no intergroup differences. Mean 24-hour PCA piritramide requirements were 22.63 mg (SD, 23.72 mg) and 26.14 mg (SD, 22.57 mg) in the celecoxib and placebo groups, respectively (P = not significant). However, patients with intraoperative dexamethasone (n = 14) required only 10.29 mg (SD, 8.55 mg) 24-hour PCA piritramide, in contrast to the 34.25 mg (SD, 24.69 mg) needed in those who did not receive intraoperative dexamethasone (P = 0.001). In addition, 24 hours after the operation, pain scores on movement were significantly lower in the dexamethasone subgroup (P = 0.003). CONCLUSION Celecoxib has no effect on postoperative pain scores and PCA piritramide requirements. The intraoperative use of 20 to 80 mg dexamethasone is able to significantly decrease postoperative piritramide consumption and pain scores on the first day after surgery.


2011 ◽  
pp. 40-44
Author(s):  

Objectives: The aim of this study is to evaluate analgesic effect of local Solu-Medrol in following lumbar disc surgery. Methods: A prospective, randomized case-control study included 49 patients, divided into 2 groups (24: control group, 25: steroid group). After discectomy, a piece of gelfoam soaked with 40 mg Solu-Medrol was left on the affected root in the steroid group. In the control group, saline soaked gelfoam was applied to the nerve root. T test to compare VAS between the two groups. Results: 24 patients (15 males, 9 females) average age of 30.2 in the control group, 25 patients (18 males, 7 females) average aged 29.8 in the steroid group. Average follow-up time 14.5 months for the control group, 14.2 months for the steroid group. Statistically significant back pain and leg pain relief (p<0.01) was observed at 1 week, 2 weeks and 1 month, but it became insignificant after 3 months. Without any complications could be related to the steroid. Conclusions: Local Solu-Medrol 40 mg is a safe and effective method in reducing back pain and radicular leg pain in early postoperative period. Key words: Local Solu-Medrol; Lumbar disc surgery.


2010 ◽  
Vol 12 (6) ◽  
pp. 666-670 ◽  
Author(s):  
Ahmed Bakhsh

Object The author conducted a study to determine the long-term outcome of lumbar disc surgery on relief of sciatic leg pain. Methods This was a retrospective observational study conducted at Fauji Foundation Hospital, Rawalpindi, Pakistan. The author reviewed medical records of 68 patients who underwent lumbar disc surgery for sciatic pain during the period 1995–2004. All patients were physically examined and interviewed. Results Lumbar disc surgery yielded complete pain relief in 79.41% of the cases. In 14.7% of the cases surgery failed to give any pain relief, and in 5.88% it yielded partial pain relief. At up to 10 years postoperatively, 27.77% of patients remained absolutely pain free. Pain recurred in 12.82% of cases after 1 year, in 35.89% during the first 5 years, and in 51.28% after 10 years. Pain recurred in the same leg in 63.88%, in the contralateral leg in 19.44%, and in both legs in 16.66%. Neurological deficits did not improve in any case except in 1 case of foot drop. New neurological deficits developed postoperatively in 8.82% of cases in the form of foot drop and calf muscle weakness. Conclusions Surgery provided immediate pain relief in 79.41% of cases, but the long-term outcome of lumbar disc surgery was not satisfactory.


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