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Differential rates of intravascular uptake and pain perception during lumbosacral epidural injection among adults using a 22-gauge needle versus 25-gauge needle: a randomized clinical trial.

ABSTRACT: BACKGROUND:Inadvertent intravascular injection has been suggested as the most probable mechanism behind serious neurological complications during transforaminal epidural steroid injections. Authors believe a smaller gauge needle may lead to less intravascular uptake and less pain. Theoretically, there is less chance for a smaller gauge needle to encounter a blood vessel during an injection compared to a larger gauge needle. Studies have also shown smaller gauge needle to cause less pain. The aim of the study was to quantify the difference between a 22-gauge needle and 25-gauge needle during lumbosacral transforaminal epidural steroid injection in regards to intravascular uptake and pain perception. METHODS:This was a prospective single blind randomized clinical trial performed at outpatient spine practice locations of two academic institutions. One hundred sixty-two consecutive patients undergoing lumbosacral transforaminal epidural injections from February 2018 to June 2019 were recruited and randomized to each arm of the study - 84 patients were randomized to the 22-gauge needle arm and 78 patients to 25-gauge arm. Each transforaminal injection level was considered a separate incidence, hence total number of incidence was 249 (136 in 22-gauge arm and 113 in 25-gauge arm). The primary outcome measure was intravascular uptake during live fluoroscopy and/or blood aspiration. The secondary outcome measure was patient reported pain during the procedure on the numerical rating scale. RESULTS:Fisher exact test was used to detect differences between 2 groups in regards to intravascular uptake and paired t-tests were used to detect differences in pain scores. The incidence of intravascular uptake for a 22-gauge needle was 5.9% (95% confidence interval: 1.9 to 9.8%) and for a 25-gauge needle, 7.1% (95% confidence interval: 2.4 to 11.8%) [p?=?0.701]. Average numerical rating scale scores during the initial needle entry for 22-gauge and 25-gauge needle was 3.46 (95% confidence interval: 2.94 to 3.98) and 3.13 (95% confidence interval: 2.57 to 3.69) respectively [p?=?0.375]. CONCLUSIONS:The study showed no statistically significant difference in intravascular uptake or pain perception between a 22-gauge needle and 25-gauge needle during lumbosacral transforaminal epidural steroid injections. TRIAL REGISTRATION:ClinicalTrials.gov NCT04350307. Registered 4/17/2020. (Retrospectively registered).

SUBMITTER: Raju R

PROVIDER: S-EPMC7469311 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Differential rates of intravascular uptake and pain perception during lumbosacral epidural injection among adults using a 22-gauge needle versus 25-gauge needle: a randomized clinical trial.

Raju Robin R Mehnert Michael M Stolzenberg David D Simon Jeremy J Conliffe Theodore T Gehret Jeffrey J

BMC anesthesiology 20200903 1

<h4>Background</h4>Inadvertent intravascular injection has been suggested as the most probable mechanism behind serious neurological complications during transforaminal epidural steroid injections. Authors believe a smaller gauge needle may lead to less intravascular uptake and less pain. Theoretically, there is less chance for a smaller gauge needle to encounter a blood vessel during an injection compared to a larger gauge needle. Studies have also shown smaller gauge needle to cause less pain. ...[more]

PMID: 32883241

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Project description:Background and Objectives: Endoscopic ultrasound (EUS) fine needle biopsy (FNB) needles were designed to improve histologic yield, while maintaining the flexibility to permit ease of use. However, the diagnostic benefit of EUS-FNB needles as compared to the conventional fine needle aspiration (FNA) needles remains unclear. This study aimed to identify the diagnostic accuracy of combined needle use of a new 20-gauge ProCore FNB needle and a 25-gauge FNA needle. Methods: For this study, cases were selected in which both the 20-gauge ProCore FNB needle and the 25-gauge FNA needle were used during a single EUS procedure for sampling of a solid pancreatic mass, lymph node, or submucosal mass. Tissue acquisition was performed in the course of the ASPRO trial, a multicenter randomized study comparing the diagnostic value of 20-gauge ProCore FNB and 25-gauge FNA needles (ClinicalTrials.gov: NCT02167074). The protocol allowed additional sampling with the nonassigned needle, at the discretion of an endosonographer. Results: Of all 615 patients who were randomized for the ASPRO study, 74 were sampled with both needle types. In these combined needle cases, FNA was used first in 24 and ProCore FNB in 50 cases. Target lesions encompassed 39 solid pancreatic lesions, 18 submucosal masses, and 17 lymph nodes. Most pancreatic lesions were located in the head (25/39), lymph nodes were mainly located in the abdomen (15/18), and submucosal lesions were located in the stomach (8/20), esophagus (4/20), small intestines (3/20), and rectum (3/20). The main reason to use ProCore in addition to FNA was to collect more tissue for ancillary testing (79%). FNA was generally used in addition to ProCore to allow for on-site pathological assessment (76%). The regimen of FNA followed by ProCore resulted in 100% accuracy, while for ProCore followed by FNA, 88% was reached (P = 0.086). The type of target lesion, either pancreatic or nonpancreatic, did not affect the diagnostic accuracy of the two sampling regimens (odds ratio 1.2, 95% confidence interval 0.22–6.61, P = 0.834). Conclusion: FNA followed by ProCore FNB provides for a 100% diagnostic accuracy and tends to outperform ProCore FNB followed by FNA. Accuracy rates were independent of the type of target lesion.

Project description:Background and Objectives: This pilot study aimed to evaluate the clinical effectiveness, cost-effectiveness, and safety of acupotomy combined with epidural steroid injection (ESI) in lumbosacral radiculopathy and examine its feasibility for the main study. Materials and Methods: This randomized, controlled, two-arm, parallel, assessor-blinded, pragmatic study included 50 patients with severe lumbosacral radiculopathy who had insufficient improvement after an ESI. Patients were randomized (1:1 ratio) into a combined treatment (acupotomy + ESI, experimental) and an ESI single treatment (control) group. Both groups underwent a total of two ESIs once every 2 weeks; the experimental group received eight additional acupotomy treatments twice a week for 4 weeks. Types of ESI included interlaminar, transforaminal, and caudal approaches. Drugs used in ESI comprised a 5-10 mL mixture of dexamethasone sodium phosphate (2.5 mg), mepivacaine (0.3%), and hyaluronidase (1500 IU). The primary outcome was the difference in changes from baseline in the Oswestry Disability Index (ODI) scores between the groups at weeks 4 and 8. The incremental cost-utility ratio (ICUR) was calculated to evaluate the cost-effectiveness between the groups. Adverse events (AEs) were assessed at all visits. Results: Mean ODI scores for the experimental and control groups were -9.44 (95% confidence interval [CI]: -12.71, -6.17) and -2.16 (95% CI: -5.01, 0.69) at week 4, and -9.04 (95% CI: -12.09, -5.99) and -4.76 (95% CI: -7.68, -1.84) at week 8, respectively. The difference in ODI score changes was significant between the groups at week 4 (p = 0.0021). The ICUR of the experimental group versus the control group was as economical as 18,267,754 won/quality-adjusted life years. No serious AEs were observed. Conclusions: These results demonstrate the potential clinical effectiveness and cost-effectiveness of acupotomy combined with ESI for lumbosacral radiculopathy and its feasibility for a full-scale study. Larger, long-term follow-up clinical trials are needed to confirm these findings.

Dataset Information

Differential rates of intravascular uptake and pain perception during lumbosacral epidural injection among adults using a 22-gauge needle versus 25-gauge needle: a randomized clinical trial.

Publications

Differential rates of intravascular uptake and pain perception during lumbosacral epidural injection among adults using a 22-gauge needle versus 25-gauge needle: a randomized clinical trial.

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