Pain Perception During Chorionic Villus Sampling
Condition: Chorionic Villi Sampling
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Chorionic villous sampling is a frequent procedure used for antenatal genetic testing. This
      procedure is associated with anxiety and fear of pain that can be expected during the
      procedure, often prejudicing patients against this definitive antenatal testing. It is
      important to determine if different approaches to pain and anxiety reduction are effective.
      Currently there is no randomized study to evaluate the efficacy of analgesia for pain
      reduction during chorionic villous sampling. Multiple studies have been published suggesting
      that analgesia during the similar procedure of amniocentesis does not significantly reduce
      pain scores.
    

Detailed description: 
      Chorionic villous sampling (CVS) is a frequent procedure used for antenatal genetic testing.
      This procedure is associated with anxiety and fear of pain that can be expected during the
      procedure, often prejudicing patients against this definitive antenatal testing. It is
      important to determine if different approaches to pain and anxiety reduction are effective.
      Previous studies have not shown that local anesthesia affects pain experience during
      amniocentesis (1-5). There are no randomized studies evaluating interventions for pain
      reduction during chorionic villous sampling which constitutes an important evidence gap.

      The study will be offered to women at <13 weeks gestation, with a singleton fetus who are
      seen at Mount Sinai Medical Center for chorionic villous sampling. The eligible women will be
      randomized to one of two groups: use of analgesia using injectable lidocaine or ethyl
      chloride topical anesthetic spray. This study intends to show that local anesthesia during
      chorionic villous sampling will not decrease the perception of pain in patients undergoing
      this procedure.

      This trial is trying to determine perception of pain based on use of injectable lidocaine or
      ethyl chloride anesthetic spray; it is noted that the form of anesthesia may be a factor in
      perception of pain. The investigators do not know if there is a difference in perception for
      topical or injectable. If the perceived pain is comparable in topical and injectable, this
      trial could conclude that both are viable options, and while both present minimal risk to
      patients, topical is less invasive.
    

Intervention name(s): Lidocaine injection; Gebauer Ethyl Chloride Spray
Intervention type(s): Drug; Drug
Intervention description(s): Injectable anesthesia is 1-2mL of 2% lidocaine via a 22 gage needle, given at the anticipated site of CVS needle puncture immediately before procedure.; Gebauer Ethyl Chloride Spray is a topical anesthetic spray which is sprayed continuously for 3-7 seconds from a distance of 3-9 inches at the site where the chorionic villus sampling is expected to take place.
Intervention MeSH terms: Lidocaine; Ethyl Chloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chorionic villus sampling; Pain; Anxiety