Local Anesthetics on Postsurgical Analgesia Following Posterior Colporrhaphy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Exparel plus plain bupivacaine; Bupivacaine
Intervention description: 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy; 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy
Intervention MeSH terms: Bupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 120.0
Sex: Female
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No

Summary:

      Effective post-surgical pain management is a crucial component of a patient's postoperative
      course following posterior colporrhaphy. Narcotics are the cornerstone for postoperative
      analgesia with a frequent re-dosing requirement, a lengthy list of side effects and adverse
      reaction risks. The colorectal, orthopedic and general surgery literatures have reported on
      an extended-release bupivacaine liposomal injection, Exparel®, which remarkably reduces acute
      post-operative pain; however, literature regarding this medication specific to Urogynecology
      and Gynecology is limited.

      The investigators propose a prospective, randomized, double blind, trial with 120 subjects
      recruited from the Walter Reed National Military Medical Center (WRNMMC) Urogynecology Clinic
      to study postsurgical pain control after posterior repair. There will be two arms in the
      study; one arm with bupivacaine alone and a second arm with bupivacaine mixed with
      Exparel®(extended-release, liposomal bupivacaine) injected vaginally in patients undergoing
      posterior colporrhaphy. Subjects will be randomized to receive either 20 milliliter (mL) of
      plain bupivacaine or 20mL (10ml+10ml) mixture of bupivacaine plus Exparel®.

      The primary objective of the trial will be to evaluate the postsurgical vaginal pain using a
      visual analog pain scale at days 1, 2, 3 post-procedure. All subjects will have
      acetaminophen, a non-steroidal anti-inflammatory drug and narcotic pain medication available
      for pain control regardless of assignment, which is the usual postoperative pain control
      regimen. The investigators hypothesize a 30% difference in post-operative pain measurements
      between the two groups.

      Additional objectives of this study are to evaluate total medication usage on days 1, 2 and 3
      and any post-operative voiding and defecatory dysfunction, comparing the two groups
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females >18 years of age undergoing Urogynecologic surgery involving the posterior
             vaginal wall mucosa or muscularis including posterior colporrhaphy at Walter Reed
             National Military Medical Center.

          -  Patients must be able to read and understand written English or have an appropriate
             certified medical translator available.

        Exclusion Criteria:

          -  Known allergy to amide local anesthetics.

          -  Unstable cardiac arrhythmia.

          -  Hepatic impairment (including but not limited to patients under the care of their
             physician for severe hepatic disease, cirrhosis or hepatic cancer).

          -  Known pregnancy at time of surgery (pregnancy test morning of surgery if applicable).

          -  Regular use of narcotic pain medication, defined as use on most days of week at any
             time in the three months prior to surgery.

          -  Significant history of opioid or alcohol abuse or addiction (requiring treatment).

          -  Concurrent pain management requiring the use of epidural anesthesia.