Randomized controlled trial of postoperative belladonna and opium rectal suppositories in vaginal surgery

Published:December 28, 2016DOI:


      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.

      Materials and Methods

      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.

      Key words

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


      Subscribe to American Journal of Obstetrics & Gynecology
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • Furlan A.D.
        • Sandoval J.A.
        • Mailis-Gagnon A.
        • Tunks E.
        Opiods for chronic noncancer pain: a meta-analysis of effectiveness and side effects.
        CMAJ. 2006; 174: 1589-1594
        • Dolin S.J.
        • Cashman J.N.
        Tolerability of acute postoperative pain management: nausea, vomiting, sedation, pruritus, and urinary retention.
        Br J Anaesth. 2005; 95: 584-591
        • Cobby T.F.
        • Crighton I.M.
        • Kyriakides K.
        • Hobbs G.J.
        Rectal paracetamol has a significant morphine-sparing effect after hysterectomy.
        Br J Anaesth. 1999; 83: 253-256
        • Ng A.
        • Parker J.
        • Toogood L.
        • Cotton B.R.
        • Smith G.
        Does the opioid-sparing effect of rectal diclofenac following total abdominal hysterectomy benefit the patient?.
        Br J Anaesth. 2002; 88: 714-716
        • Beaver W.T.
        • Feise G.A.
        A comparison of the analgesic effect of oxymorphone by rectal suppository and intramuscular injection in patients with postoperative pain.
        J Clin Pharmacol. 1977; 17: 276-291
        • Al-Husein M.O.
        Postoperative analgesia and rectal drug administration.
        Acta Anaesthesiol Scand. 2000; 44: 633-636
        • De Boer A.G.
        • Moolenaar F.
        • de Leede L.G.
        • Breimer D.D.
        Rectal drug administration: clinical pharmacokinetic considerations.
        Clin Pharmacokinet. 1982; 7: 285-311
        • Van Hoogdalem E.
        • de Boer A.G.
        • Breimer D.D.
        Pharmacokinetics of rectal drug administration: part I. general considerations and clinical applications of centrally acting drugs.
        Clin Pharmacokinet. 1991; 1: 11-26
        • Symmonds R.E.
        • Williams T.J.
        • Lee R.A.
        • Webb M.J.
        Posthysterectomy enterocele and vaginal vault prolapse.
        Am J Obstet Gynecol. 1981; 140: 852-859
        • Cruikshank S.H.
        • Kovac S.R.
        Preventing posthysterectomy vaginal vault prolapse and enterocele during vaginal hysterectomy.
        Am J Obstet Gynecol. 1987; 156: 1433-1440
        • Lee R.A.
        Atlas of gynecologic surgery.
        Saunders, Philadelphia1992: 124-130
        • Long J.B.
        • Eiland R.J.
        • Hentz J.G.
        • et al.
        Randomized trial of preemptive local analgesia in vaginal surgery.
        Int Urogynecol J Pelvic Floor Dysfunct. 2009; 20: 5-10
        • Caraceni A.
        • Cherny N.
        • Fainsinger R.
        • et al.
        Pain measurement tools and methods in clinical research in palliative care: recommendations of an expert working group of the European Association of Palliative Care.
        J Pain Symptom Manage. 2002; 23: 239-255
        • Williamson A.
        • Hoggart B.
        Pain: a review of 3 commonly used pain rating scales.
        J Clin Nurs. 2005; 14: 798-804
        • Idvall E.
        • Hamrin E.
        • Sjostrom B.
        • Unosson M.
        Patient and nurse assessment of quality of care in postoperative pain management.
        Quality Saf Health Care. 2002; 11: 327-334
        • Lukasewycz S.
        • Holman M.
        • Kozlowski P.
        • et al.
        Does a perioperative belladonna and opium suppository improve postoperative pain following robotic assisted laparoscopic radical prostatectomy? Results of a single institution randomized study.
        Can J Urol. 2010; 17: 5377-5382
        • Scavonetto F.
        • Lamborn D.R.
        • McCaffrey J.M.
        • et al.
        Prophylactic belladonna suppositories on anesthetic recovery after robotic assisted laparoscopic prostatectomy.
        Can J Urol. 2014; 20: 6799-6804
        • Brown C.R.
        • Moodie J.E.
        • Wild V.M.
        • Bynum L.J.
        Comparison of intravenous ketorolac tromethamine and morphine sulfate in the treatment of postoperative pain.
        Pharmacotherapy. 1990; 10: 116S-121S