title: Randomized controlled trial of postoperative belladonna and opium rectal suppositories in vaginal surgery.
abstract: After vaginal surgery, oral and parenteral narcotics are used commonly for pain relief, and their use may exacerbate the incidence of sedation, nausea, and vomiting, which ultimately delays convalescence. Previous studies have demonstrated that rectal analgesia after surgery results in lower pain scores and less intravenous morphine consumption. Belladonna and opium rectal suppositories may be used to relieve pain and minimize side effects; however, their efficacy has not been confirmed.
  
  
  
  We aimed to evaluate the use of belladonna and opium suppositories for pain reduction in vaginal surgery.
  
  
  
  A prospective, randomized, double-blind, placebo-controlled trial that used belladonna and opium suppositories after inpatient or outpatient vaginal surgery was conducted. Vaginal surgery was defined as (1) vaginal hysterectomy with uterosacral ligament suspension or (2) posthysterectomy prolapse repair that included uterosacral ligament suspension and/or colporrhaphy. Belladonna and opium 16A (16.2/60 mg) or placebo suppositories were administered rectally immediately after surgery and every 8 hours for a total of 3 doses. Patient-reported pain data were collected with the use of a visual analog scale (at 2, 4, 12, and 20 hours postoperatively. Opiate use was measured and converted into parenteral morphine equivalents. The primary outcome was pain, and secondary outcomes included pain medication, antiemetic medication, and a quality of recovery questionnaire. Adverse effects were surveyed at 24 hours and 7 days. Concomitant procedures for urinary incontinence or pelvic organ prolapse did not preclude enrollment.
  
  
  
  Ninety women were randomly assigned consecutively at a single institution under the care of a fellowship-trained surgeon group. Demographics did not differ among the groups with mean age of 55 years, procedure time of 97 minutes, and prolapse at 51%. Postoperative pain scores were equivalent among both groups at each time interval. The belladonna and opium group used a mean of 57 mg morphine compared with 66 mg for placebo (P=.43) in 24 hours. Patient satisfaction with recovery was similar (P=.59). Antiemetic and ketorolac use were comparable among groups. Subgroup analyses of patients with prolapse and patients <50 years old did not reveal differences in pain scores. The use of belladonna and opium suppositories was uncomplicated, and adverse effects, which included constipation and urinary retention, were similar among groups.
  
  
  
  Belladonna and opium suppositories are safe for use after vaginal surgery. Belladonna and opium suppositories did not reveal lower pain or substantially lower narcotic use. Further investigation may be warranted to identify a population that may benefit optimally from belladonna and opium use.
authors.affiliation: Department of Gynecologic Surgery, Mayo Clinic Arizona, Phoenix, AZ. Electronic address: butler.kristina@mayo.edu.
authors.forename: Kristina
authors.initials: K
authors.lastname: Butler
authors.affiliation: Department of Gynecologic Surgery, Mayo Clinic Arizona, Phoenix, AZ.
authors.forename: John
authors.initials: J
authors.lastname: Yi
authors.affiliation: Department of Gynecologic Surgery, Mayo Clinic Arizona, Phoenix, AZ.
authors.forename: Megan
authors.initials: M
authors.lastname: Wasson
authors.affiliation: Academic Urology and Urogynecology of Arizona, Sun City, AZ.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Klauschie
authors.affiliation: Division of Health Sciences Research, Mayo Clinic Arizona, Phoenix, AZ.
authors.forename: Debra
authors.initials: D
authors.lastname: Ryan
authors.affiliation: Division of Health Sciences Research, Mayo Clinic Arizona, Phoenix, AZ.
authors.forename: Joseph
authors.initials: J
authors.lastname: Hentz
authors.affiliation: Department of Gynecologic Surgery, Mayo Clinic Arizona, Phoenix, AZ.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Cornella
authors.affiliation: Department of Gynecologic Surgery, Mayo Clinic Arizona, Phoenix, AZ.
authors.forename: Paul
authors.initials: P
authors.lastname: Magtibay
authors.affiliation: Obstetrics/Gynecology & Women's Health Institute Cleveland Clinic, Cleveland, OH.
authors.forename: Roseanne
authors.initials: R
authors.lastname: Kho
mesh_terms: D000701:Analgesics, Opioid / Q000008:administration & dosage*; D000932:Antiemetics / Q000008:administration & dosage; D001532:Atropa belladonna; D004311:Double-Blind Method; D004363:Drug Utilization / Q000706:statistics & numerical data; D005260:Female; D006801:Humans; D007045:Hysterectomy, Vaginal; D008875:Middle Aged; D009020:Morphine / Q000008:administration & dosage; D009892:Opium / Q000008:administration & dosage*; D010149:Postoperative Pain / Q000517:prevention & control*; D017060:Patient Satisfaction; D056887:Pelvic Organ Prolapse / Q000601:surgery; D008517:Phytotherapy; D010936:Plant Extracts / Q000627:therapeutic use*; D011184:Postoperative Period; D011446:Prospective Studies; D013488:Suppositories; D014621:Vagina / Q000601:surgery*; D064232:Visual Analog Scale
chemical_list: D000701:Analgesics, Opioid; D000932:Antiemetics; D010936:Plant Extracts; D013488:Suppositories; D009020:Morphine; D009892:Opium
keywords: belladonna; opium; suppository