This study aimed to determine the effect of intravenous acetaminophen versus placebo on postoperative pain, satisfaction with pain control, and narcotic use after vaginal reconstructive surgery.
This was an institutional review board-approved, double-blind placebo-controlled randomized trial. Women scheduled for reconstructive surgery including vaginal hysterectomy and vaginal vault suspension were enrolled. Subjects received 1000 mg of intravenous acetaminophen or 100 mL placebo every 6 hours for 24 hours. Pain and satisfaction with pain control were assessed using visual analog scales and a numeric rating scale. Visual analog scales were collected at 18 and 24 hours postoperatively and at discharge. A sample size calculation determined 90 subjects would be required to detect a 30% reduction in postoperative narcotic use with 80% power and significance level of 0.05.
One hundred subjects were enrolled. There were no differences in demographics or surgical data and no difference in narcotic consumption at multiple evaluation points. At 18 hours postoperative, median pain scores at rest were 27.0 (interquartile range, 35.0) for acetaminophen and 35.0 (interquartile range, 44.5) for placebo, finding no difference (P = 0.465). Furthermore, pain with activity and numeric rating scale-assessed pain scales were similar (P = 0.328; P = 0.597). Although satisfaction with pain control was high overall (91.5), no difference was noted.
Patients undergoing vaginal reconstructive surgery receiving perioperative intravenous acetaminophen did not experience a decrease in narcotic requirements or postoperative pain when compared with placebo. Reassuringly, pain scores were low and satisfaction with pain control was high for all subjects. The general use of this medication is not supported in these surgical patients.
From the *Division of Urogynecology and Female Reconstructive Surgery, †Department of Obstetrics and Gynecology; and ‡Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, TriHealth Good Samaritan Hospital, Cincinnati, OH.
Reprints: Catrina C. Crisp, MD, MSC, FACOG, FPMRS, TriHealth, Division of Urogynecology and Reconstructive Surgery, Good Samaritan Hospital, 375 Dixmyth Ave, Cincinnati, OH 45040. E-mail: Catrina_crisp@trihealth.com.
This study was supported by an educational grant received from the Good Samaritan Hospital Medical Education Research Fund, Cincinnati, OH.
The authors have declared they have no conflicts of interest.
Clinicaltrials.gov no. NCT02043704.