Efficacy and Ease of Use of a Newly Designed Pencil-Point Epidural Needle Compared to Conventional Tuohy Epidural Needle: A Randomized Single-Blind Pilot Study.

Background and objective Accidental dural puncture (ADP) and consequent post-dural puncture headache (PDPH) related to epidural needle use have prompted the design of a pencil-point epidural needle. The aim of this prospective, randomized, single-blind pilot study was to assess the efficacy, ease of use, patient satisfaction, and adverse events associated with this newly designed pencil-point epidural needle compared to a Tuohy conventional epidural needle in parturients receiving combined spinal-epidural (CSE) anesthesia for labor. Methods After obtaining the Institutional Research Board approval, 100 parturients were randomized to receive CSE anesthesia with either the new pencil-point epidural needle (Gertie Marx, IMD Inc., Huntsville, UT) (P group) or Tuohy needle (T group). We documented patients' height, weight, loss of resistance (LOR), number of attempts required, onset time of spinal anesthesia, difficulties with insertion of spinal needle, difficulties with insertion of the epidural needle and catheter, duration of the procedure, overall satisfaction of the provider and patient, ADP, PDPH, paresthesia, and pain. Results There was no difference in body mass index (BMI), LOR, number of attempts, and onset time of spinal anesthetic between the study groups. Success in obtaining cerebrospinal fluid (CSF) on the first attempt was 50/51 (98%) in the T group vs. 44/49 (89.8%) in the P group (p=0.108). The need for subsequent epidural needle readjustment to obtain CSF was higher in the P group (16/49, 32.7%) vs. the T group (3/51, 5.9%, p<0.001). Success on the first attempt with epidural catheter threading was lower with the pencil-point epidural needle compared to the Tuohy needle (69% vs. 98%, p<0.001). The anesthesiologist switched from the assigned pencil-point epidural needle to the Tuohy needle due to technical difficulties in 8/49 (16.3%) cases. The duration of the procedure was longer in the P group (16.43 ±6.33 minutes) compared to the T group (11.49 ±1.87 minutes) (p<0.001). User satisfaction was lower in the P group compared to the T group (34.7% vs. 90.2%, p<0.001). Patient satisfaction was lower with the pencil-point epidural needle compared to the Tuohy needle (75.5% vs. 92.2%, p0.03). There was no difference in complication rates from the CSE procedure between groups (pain, paresthesia, ADP, and PDPH). Conclusion In this pilot study, the use of the pencil-point epidural needle for CSE was associated with less successful epidural catheter placement as well as low user and patient satisfaction compared to the Tuohy epidural needle. Modifications in the pencil-point epidural needle design are needed to improve efficacy and enhance user acceptance before a larger study can be conducted to evaluate the rates of ADP and PDPH.