Introduction: Millions of women worldwide annually undergo manual vacuum aspiration (MVA) with no pain medication, which is a violation of their basic human dignity. We designed a novel device (Chloe SED®) to administer paracervical block (PCB) during MVA in countries where pain medication is not typically given due to the high cost of the necessary tools.

Methods: We conducted a single-blinded, randomized controlled non-inferiority trial including 61 patients at two hospitals in Kisumu, Kenya, to validate Chloe SED® for administration of PCB during MVA. PCB administered with Chloe SED® was compared to PCB administered with a standard spinal needle. Patients requiring MVA were block randomized in blocks of six, each provider completing six PCBs—three with the Chloe SED® and three with the standard spinal needle. The trial was registered with the Kenya Pharmacy and Poisons Board, ECCT/19/03/01 (https://ctr.pharmacyboardkenya.org/applications/index/protocol_no:RUNDVC8xOS8wMy8wMQ__/filter:/investigator:/sites:/pages:5/start_date:/end_date:/disease_condition:/users:/ercs:/stages). An intention-to-treat analysis was completed. The primary outcome was the non-inferiority of the pain score during uterine evacuation with a non-inferiority margin of 2 points on an 11-point numerical rating scale. Secondary outcomes included the non-inferiority of the pain score at four other time points and patient satisfaction.

Results: Chloe SED® showed non-inferiority of the primary outcome with a mean pain score during evacuation of 3.8 [90% confidence interval (CI): 3.1–4.6] compared with the spinal needle at 4.1 (90% CI: 3.5–4.7). Non-inferiority of the pain score was shown at all time points. Most patients expressed a desire for the continued use of the device to administer PCB for MVA. No adverse events were noted.

Conclusion: In summary, the Chloe SED® appears non-inferior to the spinal needle and desirable for the administration of PCB during MVA.@en

Manual vacuum aspiration (MVA) is a painful procedure often conducted without analgesia. The World Health Organization (WHO) recommends a paracervical block (PCB) as the mode of pain relief during MVA. Few studies have assessed patient perspectives on pain control during MVA. We investigated the perspectives of health workers and patients on MVA under PCB. This study was nested within a pilot randomized controlled trial (RCT) evaluating the Chloe SED (syringe extension device) for PCB provision. Eleven providers and 61 patients were enrolled. All providers had MVA experience. They had not provided pain relief on 20% of occasions, and only one had previously administered PCB for MVA. Both patients and providers indicated MVA was painful and deserving of analgesia. Pain was the most common reason for difficulty completing an MVA. Providers noted that PCB made the procedure more tolerable. For patients, efficacy, remaining conscious, and same-day discharge were key considerations when selecting pain relief. Notably, 84% of patients expressed satisfaction with MVA under PCB. PCB is a vital component of the MVA care package. Considering patient and provider perspectives is essential to optimizing a humane and effective procedural experience.@en