Pharmacy and Poisons Board
Protocol No: ECCT/21/10/03 Date of Protocol: 11-08-2021
Study Title:

Validation of Chloe SED, a reusable, low-cost syringe extension device for the provision of paracervical analgesia during gynecologic procedures 
Study Objectives:

Objectives

Primary Aim: To validate the functionality of Chloe SED, a novel, low-cost, non-invasive syringe extension device for provision of paracervical analgesia during MVA in a single-blind block randomized controlled clinical trial.  Functionality will be assessed via measurement of patient pain levels during MVA utilizing either the syringe extension device (experimental arm) or standard spinal needle (control arm) to administer paracervical analgesia.

 

Secondary Aims:

  1. To assess safety of the syringe extension device via data collection on adverse outcomes.
  2. To assess provider’s experiences and opinions regarding use of the syringe extension device compared with the standard spinal needle administered block.
  3. To gather feedback on device design and improve upon the current model.
  4. To understand the acceptability and feasibility of device use and testing in western Kenya, including acceptance of the study population of randomization and blinding.
  5. To establish and strengthen research collaborations with the UIC School of Public Health and with community partners at Nyanza Reproductive Health Society in Kenya. These partnerships will be critical in further device testing, and for development of new future women’s health innovations.
  6. To assess patients’ experiences and preferences during MVA
Laymans Summary:

In many rural clinics providing women’s health services, paracervical block is impossible to perform due to the high cost of necessary tools (spinal needle, needle extender).  In these situations, women undergo manual vacuum aspiration (MVA) and other gynecologic procedures without paracervical analgesia.  We have developed a low-cost, reusable syringe extension device for the provision of paracervical analgesia during MVA.  Our initial pilot study of the device revealed that in a small sample size of 60, it is safe and non-inferior in efficacy to the standard spinal needle which is the current gold standard tool in administration of paracervical block.  We propose to further validate functionality of the device and collect user feedback from women’s health providers and patients at two sites in Western, Kenya.
Abstract of Study:

Objectives

Primary Aim: To validate the functionality of Chloe SED, a novel, low-cost, non-invasive syringe extension device for provision of paracervical analgesia during MVA in a single-blind block randomized controlled clinical trial.  Functionality will be assessed via measurement of patient pain levels during MVA utilizing either the syringe extension device (experimental arm) or standard spinal needle (control arm) to administer paracervical analgesia.

 

Secondary Aims:

  1. To assess safety of the syringe extension device via data collection on adverse outcomes.
  2. To assess provider’s experiences and opinions regarding use of the syringe extension device compared with the standard spinal needle administered block.
  3. To gather feedback on device design and improve upon the current model.
  4. To understand the acceptability and feasibility of device use and testing in western Kenya, including acceptance of the study population of randomization and blinding.
  5. To establish and strengthen research collaborations with the UIC School of Public Health and with community partners at Nyanza Reproductive Health Society in Kenya. These partnerships will be critical in further device testing, and for development of new future women’s health innovations.
  6. To assess patients’ experiences and preferences during MVA