Donna Mazloomdoost

Effects of dexamethasone on quality of recovery following vaginal surgery: a randomized trial

OBJECTIVE Dexamethasone is a corticosteroid with minimal side effects that may improve quality of recovery. We sought to evaluate standard use of this medication prior to vaginal reconstructive surgery. STUDY DESIGN This was a double-blind, randomized, placebo-controlled trial of women undergoing vaginal reconstructive surgery for pelvic organ prolapse. Patients scheduled for an intraperitoneal vaginal vault suspension, with general anesthesia and an overnight stay, were enrolled. The intervention arm received dexamethasone 60 minutes prior to surgery, and controls received placebo. Postoperative pain medications, antiemetics, and voiding trials were standardized. Our primary outcome was the difference in Quality of Recovery (QoR-40) scores on postoperative day 1. Secondary measures included Postoperative Nausea and Vomiting Intensity scores, and visual analog scales for nausea/vomiting, and pain. Our power calculation demonstrated 31 subjects in each group would be necessary to document difference in QoR-40 scores; to allow for attrition, a goal of 74 subjects was set. RESULTS Seventy-four women were enrolled and randomized. Two withdrew, 9 were excluded, and 63 were analyzed (36 placebo, 27 dexamethasone). The mean age was 63 years. No significant differences were noted among demographics other than American Society for Anesthesiologists class; there were greater numbers of dexamethasone subjects that were class 3 (5 vs 11; P = .030). Postoperatively, more patients in the placebo group required promethazine as a rescue antiemetic for control of their nausea/vomiting (11 vs 2; P = .029). Placebo subjects also failed their voiding trials more frequently, which remained following a logistic regression controlling for suburethral sling (30 vs 15; P = .037). Regarding the QoR-40 following surgery, the emotional state domain declined less in dexamethasone patients (-14.3, interquartile range [IQR], 16.8 vs -4.6, IQR, 20.1; P = .042), indicating better symptoms. Whereas pain scales were similar, the visual analog scales for nausea/vomiting was lower in dexamethasone subjects (0.7; IQR, 4.1 vs 0.4; IQR, 1.4; P = .042). Postoperative Nausea and Vomiting Intensity scores were not significantly different; nevertheless, twice as many placebo subjects had severe range symptoms (4 vs 2; P = .47). No adverse effects from the dexamethasone were noted. CONCLUSION Use of dexamethasone prior to vaginal reconstructive surgery was associated with less nausea/vomiting and need for antiemetics as well as greater success with voiding trials. Furthermore, quality of recovery was enhanced, suggesting use of dexamethasone should be considered for these patients.

The Effect of Intravenous Acetaminophen on Postoperative Pain and Narcotic Consumption After Vaginal Reconstructive Surgery: A Double-Blind Randomized Placebo-Controlled Trial

Objective 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. Methods 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. Results 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. Conclusions 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.

Liposomal bupivacaine decreases pain following retropubic sling placement: a randomized placebo-controlled trial

BACKGROUND: Midurethral slings are commonly used to treat stress urinary incontinence. Pain control, however, may be a concern. Liposomal bupivacaine is a local anesthetic with slow release over 72 hours, demonstrated to lower pain scores and decrease narcotic use postoperatively. OBJECTIVE: The purpose of this study was to examine the impact of liposomal bupivacaine on pain scores and narcotic consumption following retropubic midurethral sling placement. STUDY DESIGN: This randomized, placebo‐controlled trial enrolled women undergoing retropubic midurethral sling procedures with or without concomitant anterior or urethrocele repair. Subjects were allocated to receive liposomal bupivacaine (intervention) or normal saline placebo injected into the trocar paths and vaginal incision at the conclusion of the procedure. At the time of drug administration, surgeons became unblinded, but did not collect outcome data. Participants remained blinded to treatment. Surgical procedures and perioperative care were standardized. The primary outcome was the visual analog scale pain score 4 hours after discharge home. Secondary outcomes included narcotic consumption, time to first bowel movement, and pain scores collected in the mornings and evenings until postoperative day 6. The morning pain item assessed “current level of pain”; the evening items queried “current level of pain,” “most intense pain today,” “average pain today with activity,” and “average pain today with rest.” Likert scales were used to measure satisfaction with pain control at 1‐ and 2‐week postoperative intervals. Sample size calculation deemed 52 subjects per arm necessary to detect a mean difference of 10 mm on a 100‐mm visual analog scale. To account for 10% drop out, 114 participants were needed. RESULTS: One hundred fourteen women were enrolled. After 5 exclusions, 109 cases were analyzed: 54 women received intervention, and 55 women received placebo. Mean participant age was 52 years, and mean body mass index was 30.4 kg/m2. Surgical and demographic characteristics were similar, except for a slightly higher body mass index in the placebo group (31.6 vs 29.2 kg/m2; P=.050), and fewer placebo arm subjects received midazolam during anesthesia induction (44 vs 52; P=.015). For the primary outcome, pain score (millimeter) 4 hours after discharge home was lower in the intervention group (3.5 vs 13.0 millimeters; P=.014). Pain scores were also lower for subjects receiving liposomal bupivacaine at other time points collected during the first three postoperative days. Furthermore, fewer subjects in the intervention group consumed narcotic medication on postoperative day 2 (12 vs 27; P=.006). There was no difference in satisfaction with pain control between groups. Side‐effects experienced, rate of postoperative urinary retention, and time to first bowel movement were similar between groups. Finally, no serious adverse events were noted. CONCLUSION: Liposomal bupivacaine decreased postoperative pain scores following retropubic midurethral sling placement, though pain was low in both the intervention and placebo groups. Participants who received liposomal bupivacaine were less likely to use narcotics on postoperative day 2. For this common outpatient surgery, liposomal bupivacaine may be a beneficial addition. Given the cost of this intervention, however, future cost‐effective analyses may be useful.

A Comprehensive Review of the Clitoris and Its Role in Female Sexual Function.

INTRODUCTION The clitoris is often considered the female version of the penis and less studied compared to its male counterpart. Nonetheless, it carries the same importance in sexual functioning. While it has more recently been allocated the appreciation it deserves, the clitoris should be examined as a separate and unique entity. AIM To review clitoral anatomy, its role in sexual functioning, the controversies of vaginal eroticism and the female prostate, as well as address potential impacts of pelvic surgery on its function. METHODS We examined available evidence (from 1950 until 2015) relating to clitoral anatomy, the clitoral role in sexual functioning, vaginal eroticism, female prostate, female genital mutilation/cutting, and surgical implications for the clitoris. MAIN OUTCOME MEASURES Main outcomes included an historical review of the clitoral anatomy and its role in sexual functioning, the controversies regarding vaginal sources of sexual function, and the impact of both reconstructive and nonmedical procedures on the clitoris. RESULTS The intricate neurovasculature and multiplanar design of the clitoris contribute to its role in female sexual pleasure. Debate still remains over the exclusive role of the clitoris in orgasmic functioning. Normal sexual function may remain intact, however, after surgical procedures involving the clitoris and surrounding structures. CONCLUSIONS The clitoris is possibly the most critical organ for female sexual health. Its importance is highlighted by the fact that the practice of female genital cutting is often used to attenuate the female sexual response. While its significance may have been overshadowed in reports supporting vaginal eroticism, it remains pivotal to orgasmic functioning of most women. Donna Mazloomdoost and Rachel N. Pauls. A comprehensive review of the clitoris and its role in female sexual function.

To Pack or Not to Pack? A Randomized Trial of Vaginal Packing After Vaginal Reconstructive Surgery.

Objective Placement of vaginal packing after pelvic reconstructive surgery is common; however, little evidence exists to support the practice. Furthermore, patients have reported discomfort from the packs. We describe pain and satisfaction in women treated with and without vaginal packing. Methods This institutional review board–approved randomized-controlled trial enrolled patients undergoing vaginal hysterectomy with prolapse repairs. The primary outcome was visual analog scales (VASs) for pain on postoperative day 1. Allocation to “packing” (“P”) or “no-packing” (“NP”) arms occurred intraoperatively at the end of surgery. Visual analog scales regarding pain and satisfaction were completed early on postoperative day 1 before packing removal. Visual analog scale scores for pain, satisfaction, and bother attributable to packing were recorded before discharge. All packing and perineal pads were weighed to calculate a “postoperative vaginal blood loss.” Perioperative data were collected from the hospital record. Our sample size estimation required 74 subjects. Results Ninety-three women were enrolled. After exclusions, 77 were randomized (P, 37; NP, 40). No differences were found in surgical information, hemoglobin levels, or narcotic use between groups. However, “postoperative vaginal blood loss” was greater in packed subjects (P < 0.001). Visual analog scale scores for pain before removal of packing (P, 41.6 vs NP, 46.3; P = 0.43] and before discharge (P, 35.0 vs NP, 40.0; P = 0.43] were not significantly different between treatment arms. Likewise, VAS scores for satisfaction before removal of packing (P, 81.0 vs NP, 90.0; P = 0.08] and before discharge (P, 90.0 vs NP, 90.5; P = 0.60] were not significantly different. Packed patients noted lower nursing verbal pain scores (P = 0.04) and used less ketorolac (P = 0.01). Bother from packing was low overall. Conclusions Although there was no difference based on VAS, women receiving vaginal packing had lower nursing documented pain and used less ketorolac than packed women. Vaginal packing may provide benefit and can remain part of the surgical practice.

Survey of male perceptions regarding the vulva

OBJECTIVE The purpose of this study was to characterize male preferences of vulvar appearance, their awareness of labiaplasty, and their knowledge of genital anatomy. STUDY DESIGN Men 18-80 years old were recruited via emails sent by an Internet provider to participate in a 27-question web-based survey. The questionnaire included images and queried demographics, mens familiarity with vulvar anatomy, preferences regarding labial appearance, and awareness of labiaplasty. Two deployments to >150,000 email addresses were sent. Demographic data were described using frequencies for categoric variables and mean measures of central tendency for continuous variables. Logistic regression models were used to analyze associations between demographics and responses. RESULTS Two thousand four hundred three men responded to the survey. After excluding incomplete and ineligible surveys, 1847 surveys were analyzed. The median age of respondents was 55 years. The majority was white (87%), married (68%), employed (69%), and had completed high school or beyond (97%). One-third of the respondents lived in the South, with the other regions nearly equally represented. A significant majority, 95%, reported having been sexually active with women, and 86% felt comfortable labeling the vulvar anatomy. With regard to preferences, more respondents considered smaller labia attractive compared to large labia; yet 36% of the men remained neutral. Men also showed a preference for partially or completely groomed genitals compared to natural hair pattern. Whereas 51% of participants believed the appearance of a womans labia influenced their desire to engage in sexual activity, 60% denied it affected sexual pleasure. Only 42% of men were familiar with labiaplasty, and 75% of all respondents would not encourage a female partner to change her genital appearance. Multivariable analysis revealed younger age to be associated with preferences for small labia and complete genital hair removal, as well as familiarity with labiaplasty. CONCLUSION In this national survey, men demonstrated familiarity with the female anatomy, but many did not feel it impacted sexual desire or pleasure. Moreover, the majority lacked strong preferences for a specific vulvar appearance and would not encourage a female partner to alter her genital appearance surgically.

Histologic Anatomy of the Anterior Vagina and Urethra

Background Vaginal and urethral histology is important to understanding the pathophysiology of the pelvic floor. Methods En bloc removal of 4 female cadaveric pelvises was performed, with 18 to 25 serial sections obtained from each. The vaginal and urethral lengths were divided into distal and proximal sections; urethra was divided into anterior and posterior segments as well. Innervation and vasculature were qualified as small and large and quantified per high-power field. Results The mean vaginal length was 7.45 cm, and the mean urethral length was 3.38 cm. A distinct vaginal fibromuscular layer was noted, without evidence of a dense sheet of continuous collagen. An epithelial, lamina propria, and muscular layer surrounded the urethral lumen. Adipose and loose fibroconnective tissue separated the urethra from the anterior vagina in 41% of slides. Nerves and vasculature were concentrated in the lamina propria. More small nerves and vessels were grossly seen compared with larger counterparts in both the vagina and urethra. No significant differences in layer thickness, innervation, or vasculature were observed along the vaginal length. The posterior urethra had greater innervation than did the anterior (P = 0.012). The distal posterior urethra had more large vessels than did the proximal posterior urethra (P = 0.03). No other differences were noted in urethral sections. Conclusions A vaginal fibromuscular layer was confirmed, refuting a true fascia. Innervation and vasculature were quantitatively the same along the anterior vagina. However, the posterior urethra had greater innervation than did anterior and is most innervated proximally. Nerve and vascular histology may relate to pelvic floor disorder etiology.

Comparative Perioperative Pain and Recovery in Women Undergoing Vaginal Reconstruction Versus Robotic Sacrocolpopexy.

Background In this study of patients undergoing vaginal hysterectomy with either robotic or vaginal prolapse repair, there was no difference in quality of life in the weeks following surgery; however, less narcotics were used, less pain was documented by nurses and Surgical Pain Scale (SPS), and better performance on voiding trials was noted in those undergoing robotic sacrocolpopexy. Objectives Minimally invasive surgery for pelvic organ prolapse is the preferred surgical route for optimal recovery. However, information regarding patient-centered outcomes among various techniques is lacking. We sought to describe pain and quality of life in patients undergoing vaginal hysterectomy with uterosacral ligament suspension (USLS) compared with robotic-assisted sacrocolpopexy (RSC). Methods This institutional review board–approved prospective cohort study enrolled consecutive patients undergoing vaginal hysterectomy with USLS or with RSC. The primary outcome was pain on postoperative day 1 using the SPS. Nursing verbal pain scores, narcotic usage, surgical data, and Short-Form Health Survey 12 at baseline and 2 and 6 weeks after surgery were collected. A sample size calculation revealed 37 subjects per group would be required. Results Seventy-eight women were enrolled (USLS, n = 39; RSC, n = 39). There were no significant differences in scores on the SPS between groups. Subjects undergoing RSC had lower nursing verbal pain scores (P = 0.04), less narcotic consumption (P = 0.02), and lower estimated blood loss (P = 0.01) and were less likely to fail voiding trials (P < 0.001); however, surgery duration was longer (P < 0.001). After controlling for age, regression analysis revealed SPS “worst pain” was lower in the robotic arm (P = 0.01), but not in other scales of the SPS. At 2 and 6 weeks postoperatively, Short-Form Health Survey 12 scores were not different between cohorts. Conclusions Both USLS and RSC are minimally invasive, with similar quality-of-life scores after surgery. However, the robotic approach may be associated with less pain, less narcotic use, and better performance in voiding trials. Surgeons should consider these findings when counseling patients regarding treatment options.

Gaining The Patient Perspective on Pelvic Floor Disorders’ Surgical Adverse Events

Background: The Institute for Healthcare Improvement defines an adverse event as an unintended physical injury resulting from or contributed to by medical care that requires additional monitoring, treatment, or hospitalization or that results in death. The majority of research has focused on adverse events from the providers perspective. Objective: The objective of this qualitative study was to describe patient perceptions on adverse events following surgery for pelvic floor disorders. Study Design: Women representing the following 3 separate surgical populations participated in focus groups: (1) preoperative (women <12 weeks prior to surgery); (2) short‐term postoperative (women up to 12 weeks after surgery); and (3) long‐term postoperative (women 1–5 years after surgery). Deidentified transcripts of audio recordings were coded and analyzed with NVivo 10 software to identify themes, concepts, and adverse events. Women were asked to rank patient‐identified and surgeon‐identified adverse events in order of perceived severity. Results: Eighty‐one women participated in 12 focus groups. Group demographics were similar between groups, and all groups shared similar perspectives regarding surgical expectations. Women commonly reported an unclear understanding of their surgery and categorized adverse events such as incontinence, constipation, nocturia, and lack of improvement in sexual function as very severe, ranking these comparably with intensive care unit admissions or other major surgical complications. Women also expressed a sense of personal failure and shame if symptoms recurred. Conclusion: Women consider functional outcomes such as incontinence, sexual dysfunction, and recurrence of symptoms as severe adverse events and rate them as similar in severity to intensive care unit admissions and death.

Liposomal Bupivacaine During Robotic Colpopexy and Posterior Repair: A Randomized Controlled Trial

OBJECTIVE To evaluate the effect of liposomal bupivacaine on postoperative pain among patients undergoing robotic sacrocolpopexy with posterior repair. METHODS This was a randomized, patient-blinded, placebo-controlled trial of women undergoing robotic sacrocolpopexy with posterior repair. Liposomal bupivacaine or normal saline placebo was injected into laparoscopic and vaginal incisions at completion of surgery. Perioperative care was standardized. Visual analog scales were collected at 4, 18, and 24 hours postoperatively in hospital. Starting on postoperative day 1, participants completed twice-daily pain scales and a pain medication diary up until the evening of postoperative day 3. The primary outcome was a 20-mm change in the visual analog scale 18 hours postoperatively. Secondary measures included additional pain scores, satisfaction, and narcotic use. Sample size calculation revealed that 32 patients per arm were required to detect the 20-mm difference with 90% power and an α of 0.05. To allocate for dropout, a goal of 70 was set. RESULTS Between March 2015 and April 2016, 100 women were screened and 70 women were enrolled: 35 women were randomized to liposomal bupivacaine and 35 to placebo, of whom 64 (91%) were included in the final analysis: 33 liposomal bupivacaine and 31 placebo. No difference in demographics, surgical data, or satisfaction between groups was noted. Median VAS at 18 hours after surgery was not statistically different in those who received liposomal bupivacaine compared with normal saline (15 mm compared with 20 mm; P=.52). Other pain scales and total morphine equivalents were also similar (P=.90). CONCLUSION In this study of robotic sacrocolpopexy with posterior repair, there were no differences in pain scores or narcotic use between liposomal bupivacaine and placebo injected into laparoscopic and vaginal incisions. Given its lack of clinical benefit, routine use of liposomal bupivacaine is not supported for this surgical intervention. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov, NCT02449915.