Decreasing Postoperative Pain Following Endometrial Ablation
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      To determine whether paracervical injection of long acting local anesthesia decreases
      postoperative pain following endometrial ablation under general anesthesia.
    

Detailed description: 
      Destruction of the endometrial lining to control bothersome uterine bleeding has been
      implemented since 1937. Currently there are various different 'second generation' energy
      sources to avert such bleeding, five of which are now approved in the United States. These 5
      second generation devices include: Thermachoice/Cavaterm, which use high temperature fluid
      within a balloon; Microsulis, which applies microwaves; Novasure, which uses bipolar energy;
      Hydrothermablator, which uses free fluid at high temperatures; ELITT, which uses laser
      thermotherapy; and HerOption, which uses cryoablation. Patient selection for endometrial
      ablation is crucial, as it is intended for premenopausal women with normal uterine cavities
      and no desire for future fertility that are affected by heavy menstrual bleeding. Since the
      introduction of the initial 'second generation' device in 1997 these modalities have
      overtaken the industry mostly due to their ease of use and shorter operative times.
      Regardless, a Cochrane review finds insufficient evidence to prove superiority of these newer
      modalities over the traditional 'gold standard' resectoscopic technique.

      Endometrial ablation has been demonstrated in a variety of settings including outpatient
      surgical centers as well as physician's offices. Evidence suggests that microwave endometrial
      ablation under local anesthesia is a safe and acceptable practice. Very often, when
      endometrial ablation is performed as an outpatient procedure, patients are pre-medicated and
      then receive a paracervical injection of local anesthesia to control pain intraoperatively.
      When endometrial ablations are performed as an outpatient procedure through a surgical
      center, a variety of anesthesia techniques are employed depending on the infrastructure and
      human and institutional resources available. These techniques may vary from conscious
      sedation to general anesthesia, all of which have been proven to be acceptable methods.

      In this center endometrial ablations are performed as an outpatient procedure under general
      anesthesia with a variety of induction techniques and intraoperative pain management
      practices. According to physician preference, patients may receive an additional paracervical
      injection of local anesthetic before the procedure, immediately after, or not at all. To
      date, there are no studies evaluating the efficacy of local anesthetic in addition to general
      anesthesia for patients receiving endometrial ablation to guide physician practice. The
      purpose of this study is to evaluate the efficacy of local anesthetic, in addition to general
      anesthesia, in our large, community-based patient population, in meaningfully decreasing
      postoperative pain.
    

Intervention name(s): Bupivacaine; Normal Saline
Intervention type(s): Drug; Other
Intervention description(s): Paracervical injection of 20 mL 0.25% Bupivacaine at the completion of the procedure; Equal volume injection of normal saline with the same paracervical technique
Other intervention name(s): Marcaine, Sensorcaine
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment