Background
Patients undergoing vaginal hysterectomy with native tissue pelvic reconstruction
typically have low pain levels overall in the postoperative period. Notwithstanding,
pain control immediately after surgery may be more challenging and a barrier to same-day
discharge. Intrarectal diazepam has been used for acute and chronic pelvic pain and
has a pharmacokinetic profile ideal for intermittent use. However, its use has not
been investigated after the surgical intervention.
Objective
This study aimed to evaluate the effect of diazepam rectal suppositories on early
postoperative pain after hysterectomy and vaginal reconstruction for pelvic organ
prolapse.
Study Design
This was a double-blind, randomized, placebo-controlled trial comparing postoperative
pain scores after vaginal hysterectomy with native tissue prolapse repairs. Patients
were randomized to receive either an intrarectal 10-mg diazepam suppository or an
identical placebo. Moreover, the participants completed the questionnaires at baseline,
the morning of postoperative day 1, and 2 weeks after the operation. Surveys included
visual analog scales for pain, a validated Surgical Satisfaction Questionnaire, and
queries regarding medication side effects and postoperative recovery. The primary
outcome was pain scores based on a visual analog scale approximately 3 hours after
surgery. The secondary outcomes included total morphine equivalents after surgery,
patient satisfaction with pain control, same-day discharge outcome, and overall satisfaction.
The chi-square, Fisher exact, and Mann-Whitney tests were used. Based on a 10-mm difference
in postoperative vaginal pain using the visual analog scale, sample size was calculated
to be 55 patients in each arm to achieve 80% power with an alpha of.05.
Results
From February 2020 to August 2021, 130 participants were randomized. Of those participants,
7 withdrew, and 123 were analyzed: 60 in the diazepam group and 63 in the placebo
group. The median age was 65 years (interquartile range, 27–80), the median body mass
index was 27.9 kg/m2 (interquartile range, 18.70–45.90), and 119 of 123 participants (96.7%) were White.
There was no difference in the baseline characteristics, prolapse stage, or types
of procedures performed between groups. Most participants had concurrent uterosacral
ligament suspension with anterior and posterior repairs. Of note, 50 of 123 participants
(41%) had midurethral slings. Moreover, 61 of 123 participants (50%) were discharged
on the day of surgery. There was no difference in the primary outcome of vaginal pain
3.5 to 6.0 hours postoperatively (25 vs 21 mm; P=.285). In addition, the amount of rescue narcotics used in the immediate postoperative
period (19.0 vs 17.0 MME; P=.202) did not differ between groups. At 2-weeks postoperatively, patients in the
placebo group reported higher satisfaction with pain control in the hospital (31 vs
43 mm; P=.006) and pain control at home (31 vs 42 mm; P=.022). No difference was noted between same-day discharges and those who were admitted
overnight.
Conclusion
The placement of a 10-mg diazepam rectal suppository immediately after pelvic reconstructive
surgery did not improve pain or narcotic usage in the early postoperative period.
Although the placebo group reported slightly higher satisfaction with pain control
2 weeks after surgery, overall pain levels were low. Therefore, we do not believe
that the addition of diazepam to the postoperative regimen is warranted.
Key words
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References
- Postoperative opioid prescribing after female pelvic medicine and reconstructive surgery.Female Pelvic Med Reconstr Surg. 2021; 27: 643-653
- Low pain score after total laparoscopic hysterectomy and same-day discharge within less than 5 hours: results of a prospective observational study.J Minim Invasive Gynecol. 2015; 22: 1293-1299
- A novel injection technique for extended-release local anesthetic after posterior colporrhaphy and perineorrhaphy: a randomized controlled study.Female Pelvic Med Reconstr Surg. 2021; 27: 344-350
- Outpatient vaginal hysterectomy: comparison of conventional suture ligature versus electrosurgical bipolar vessel sealing.J Gynecol Obstet Hum Reprod. 2017; 46: 399-404
- Randomized trial of preemptive local analgesia in vaginal surgery.Int Urogynecol J Pelvic Floor Dysfunct. 2009; 20: 5-10
- The effect of intravenous acetaminophen on postoperative pain and narcotic consumption after vaginal reconstructive surgery: a double-blind randomized placebo-controlled trial.Female Pelvic Med Reconstr Surg. 2017; 23: 80-85
- Liposomal bupivacaine during robotic colpopexy and posterior repair: a randomized controlled trial.Obstet Gynecol. 2018; 131: 39-46
- A comprehensive model for pain management in patients undergoing pelvic reconstructive surgery: a prospective clinical practice study.Am J Obstet Gynecol. 2020; 223: 262.e1-262.e8
- Optimizing perioperative pain control after ambulatory urogynecologic surgery.Female Pelvic Med Reconstr Surg. 2020; 26: 483-487
- Recovery at home after major gynecologic surgery: how do our patients fare?.Obstet Gynecol. 2012; 119: 780-784
- New topical treatment of vulvodynia based on the pathogenetic role of cross talk between nociceptors, immunocompetent cells, and epithelial cells.J Pain Res. 2016; 9: 757-762
- Multidisciplinary evaluation and treatment of vulvar disorders. Innovation Compounding Pharmacy.(Available at:)
- Vaginal diazepam use with urogenital pain/pelvic floor dysfunction: serum diazepam levels and efficacy data.Urol Nurs. 2011; 31 (299): 279-284
- Advances in the treatment of chronic pelvic pain: a multidisciplinary approach to treatment.Mo Med. 2017; 114: 47-51
- Retrospective chart review of vaginal diazepam suppository use in high-tone pelvic floor dysfunction.Int Urogynecol J. 2010; 21: 895-899
- Randomized controlled trial of postoperative belladonna and opium rectal suppositories in vaginal surgery.Am J Obstet Gynecol. 2017; 216: 491.e1-491.e6
- Effectiveness of a pre-emptive preoperative belladonna and opium suppository on postoperative urgency and pain after ureteroscopy.J Perianesth Nurs. 2019; 34: 594-599
- Preoperative belladonna and opium suppository for ureteral stent pain: a randomized, double-blinded, placebo-controlled study.Urology. 2017; 100: 27-32
- Validation of the surgical pain scales in women undergoing pelvic reconstructive surgery.Female Pelvic Med Reconstr Surg. 2012; 18: 198-204
- Quality of life and surgical satisfaction after vaginal reconstructive vs obliterative surgery for the treatment of advanced pelvic organ prolapse.Am J Obstet Gynecol. 2008; 198: 573.e1-573.e7
- Vaginal diazepam for nonrelaxing pelvic floor dysfunction: the pharmacokinetic profile.J Sex Med. 2019; 16: 763-766
Diazepam. In: Lexi-drugs online [database on the Internet]. Hudson (OH): Lexicomp, Inc.; 2022 [updated 16 May 2022]. Available at: http://online.lexi.com. Accessed November 8, 2019.
- Intra-vaginal diazepam for high-tone pelvic floor dysfunction: a randomized placebo-controlled trial.Int Urogynecol J. 2013; 24: 1915-1923
- Intravaginal diazepam for the treatment of pelvic floor hypertonic disorder: a double-blind, randomized, placebo-controlled trial.Female Pelvic Med Reconstr Surg. 2019; 25: 76-81
- Multimodal opioid-sparing postoperative pain regimen compared with the standard postoperative pain regimen in vaginal pelvic reconstructive surgery: a multicenter randomized controlled trial.Am J Obstet Gynecol. 2019; 221: 511.e1-511.e10
- Enhanced recovery program for minimally invasive and vaginal urogynecologic surgery.Int Urogynecol J. 2019; 30: 313-321
- The lancet handbook of essential concepts in clinical research.1st ed. The Lancet, England, United Kingdom2006
- Physiological and pharmaceutical considerations for rectal drug formulations.Front Pharmacol. 2019; 10: 1196
Article info
Publication history
Published online: May 09, 2022
Accepted:
May 2,
2022
Received in revised form:
April 25,
2022
Received:
December 21,
2021
Footnotes
The authors report no conflict of interest.
This study received funding from the TriHealth Medical Education Research Fund. The funding source had no role in the development, data collection or analysis, or writing of this report.
This study was registered on ClinicalTrials.gov (identification number: NCT04198233; https://clinicaltrials.gov/ct2/show/NCT04198233). The clinical trial date of registration was on December 13, 2019. The date of initial participant enrollment was on February 12, 2020.
Individual participant data will be available. All enrollment and collected data will be shared. Study protocol, informed consent document, data collection forms will be available. Data will be available on study publication. Data will be shared via secured messaging system with interested parties for secondary analyses.
Cite this article as: Aldrich ER, Tam TY, Saylor LM, et al. Intrarectal diazepam following pelvic reconstructive surgery: a double-blind, randomized placebo-controlled trial. Am J Obstet Gynecol 2022;227:302.e1-9.
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