Atraumatic Needles in Hematology LP: SPPLAASH Study

Postdural-puncture headache (PDPH) is a prevalent complication following LP, potentially arising from cerebrospinal fluid (CSF) leakage into the epidural space. Occurring within 8 days, PDPH severely impacts quality of life (QoL), lacking robust preventive or therapeutic measures. Needle tip shape, a proposed risk factor, influences diagnostic lumbar puncture (LP) scenarios, particularly in leukemia and lymphoma.

Yann Guillermin and his team aimed to evaluate PDPH incidence using conventional (cutting-type) versus atraumatic (pencil-point) spinal needles in hematological patients. The objective was to determine if traumatic needles could mitigate severe PDPH incidence and duration, offering a safer alternative in LP procedures within this vulnerable population.

The study performed an inclusive analysis through a randomized, double-blind approach involving 68 adult patients slated for diagnostic and/or therapeutic LP as part of the SPPLAASH study (NCT03126045). Participants were randomly allocated to receive a 22-gauge cutting needle (n=36) or a 26-gauge atraumatic needle (n=32). LP and CSF collection adhered to standardized procedures. The primary outcome, severe headache (≥4 out of 10 on the numerical rating scale (NRS)), was assessed through interviews conducted for 8 days post-LP and repeated until headache resolution. Secondary outcomes encompassed maximum intensity and duration of PDPH and procedural failure evaluation.

The median age at the time of LP was 60 years (Q1-Q3, 46-70), with 40% of the participants being women. Demographic and procedural characteristics indicated no statistically significant differences between the two treatment groups, except for LP indication. The overall rate of severe PDPH was 19.7% (95% CI – 10.9-31.3).

Significantly, the incidence of severe PDPH exhibited a notable reduction from 31.3% (95% CI – 16.9-49.3) in the conventional needle group to 6.5% (95% CI – 0.8-21.4) in the atraumatic group (P=0.011). Factors associated with a lower risk of PDPH included a high body mass index (OR 0.72, 95% CI 0.57-0.91) and male sex (OR 0.29, 95% CI 0.08-1).

Means of the maximum intensity of PDPH at 8 days was estimated to be 2.3 (sd 3.1) in the conventional needle group and 0.7 (sd 1.31) in the atraumatic group. Statistically significant differences were observed in median intensities (P=0.032) and the number of days with NRS ≥4 (P=0.030). The Sankey flow mapped trajectories of PDPH intensities during the 8-day follow-up.

First-attempt LP success, failure rate, the mean number of attempts, and the frequency of analgesic prescriptions did not statistically differ between the two needle groups.

The study concluded that LP, integral to hematologic clinical care and research, decreases severe PDPH incidence and duration when utilizing atraumatic needles. 

The findings supported the safety and feasibility of atraumatic needle usage. Recognizing the significant impact of PDPH on the QoL, especially amid hematological treatments, and considering potential differential diagnoses (e.g. cerebral sinus venous thrombosis due to Asparaginase in acute lymphoblastic leukemia), the study advocates for the encouragement of atraumatic needle adoption in this patient population, frequently undergoing multiple LP.

The study is sponsored by Centre Hospitalier Universitaire de Saint Etienne

Source: https://ash.confex.com/ash/2023/webprogram/Paper180601.html

Clinical Trial: https://clinicaltrials.gov/study/NCT03126045

Guillermin Y, Biostat S M, Thévenet U, et al. (2023). “Spplaash Study: A Randomized Study to Evaluate the Incidence of Postdural Puncture Headache with the Use of Atraumatic Needles in Hematology.” Presented at ASH 2023 (Abstract 129).