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Incidence of opioid-managed pelvic pain after hysteroscopic sterilization versus laparoscopic sterilization, US 2005-2012.

ABSTRACT: Compare incidence of opioid-managed pelvic pain within 12?months after hysteroscopic and laparoscopic sterilization.Using administrative claims, we identified women aged 18-49?years without recent history of childbirth who underwent hysteroscopic or laparoscopic sterilization between 2005 and 2012. We defined the outcome as ?2 diagnoses for pelvic pain and ?2 prescription fills for opioids. We calculated adjusted hazard ratios (HR) using Cox models and propensity score methods (matching and inverse-probability-of-treatment-weighting [IPTW]).We identified 71,875 eligible women (hysteroscopic n?=?26,927 [37.5%], laparoscopic n?=?44,948 [62.5%]). Of those, 236 (0.88%) hysteroscopic patients and 420 (0.93%) laparoscopic patients experienced the outcome (crude HR?=?0.97, 95%CI: [0.83, 1.14]). Adjusted analyses also yielded near-null results (matched HR?=?1.08, 95%CI [0.90, 1.31]; IPTW HR?=?0.97, 95%CI [0.80, 1.18]). While most sensitivity analyses generated results close to the null, hazard ratios estimated using propensity score matching ranged from 0.65 to 1.53.Among women without recent history of childbirth, we did not find compelling evidence of a clinically meaningful increase in the incidence of pelvic pain requiring opioids during the year after hysteroscopic sterilization. However, effects observed in sensitivity analyses may merit further investigation.

SUBMITTER: Conover MM

PROVIDER: S-EPMC4527877 | biostudies-literature | 2015 Aug

REPOSITORIES: biostudies-literature

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Incidence of opioid-managed pelvic pain after hysteroscopic sterilization versus laparoscopic sterilization, US 2005-2012.

Conover Mitchell M MM Howell Jennifer O JO Wu Jennifer M JM Wu Jennifer M JM Kinlaw Alan C AC Dasgupta Nabarun N Jonsson Funk Michele M

Pharmacoepidemiology and drug safety 20150331 8

<h4>Objective</h4>Compare incidence of opioid-managed pelvic pain within 12 months after hysteroscopic and laparoscopic sterilization.<h4>Methods</h4>Using administrative claims, we identified women aged 18-49 years without recent history of childbirth who underwent hysteroscopic or laparoscopic sterilization between 2005 and 2012. We defined the outcome as ≥2 diagnoses for pelvic pain and ≥2 prescription fills for opioids. We calculated adjusted hazard ratios (HR) using Cox models and propensit ...[more]

PMID: 25832014

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Project description:ObjectiveTo compare the safety and efficacy of hysteroscopic sterilization with the "Essure" device with laparoscopic sterilization in a large, all-inclusive, state cohort.DesignPopulation based cohort study.SettingsOutpatient interventional setting in New York State.ParticipantsWomen undergoing interval sterilization procedure, including hysteroscopic sterilization with Essure device and laparoscopic surgery, between 2005 and 2013.Main outcomes measuresSafety events within 30 days of procedures; unintended pregnancies and reoperations within one year of procedures. Mixed model accounting for hospital clustering was used to compare 30 day and 1 year outcomes, adjusting for patient characteristics and other confounders. Time to reoperation was evaluated using frailty model for time to event analysis.ResultsWe identified 8048 patients undergoing hysteroscopic sterilization and 44,278 undergoing laparoscopic sterilization between 2005 and 2013 in New York State. There was a significant increase in the use of hysteroscopic procedures during this period, while use of laparoscopic sterilization decreased. Patients undergoing hysteroscopic sterilization were older than those undergoing laparoscopic sterilization and were more likely to have a history of pelvic inflammatory disease (10.3% v 7.2%, P<0.01), major abdominal surgery (9.4% v 7.9%, P<0.01), and cesarean section (23.2% v 15.4%, P<0.01). At one year after surgery, hysteroscopic sterilization was not associated with a higher risk of unintended pregnancy (odds ratio 0.84 (95% CI 0.63 to 1.12)) but was associated with a substantially increased risk of reoperation (odds ratio 10.16 (7.47 to 13.81)) compared with laparoscopic sterilization.ConclusionsPatients undergoing hysteroscopic sterilization have a similar risk of unintended pregnancy but a more than 10-fold higher risk of undergoing reoperation compared with patients undergoing laparoscopic sterilization. Benefits and risks of both procedures should be discussed with patients for informed decisions making.

Project description:ImportanceSafety of hysteroscopic sterilization has been recently questioned following reports of general symptoms such as allergy, tiredness, and depression in addition to associated gynecological results such as pelvic pain, perforation of fallopian tubes or uterus, and unwanted pregnancy.ObjectiveTo compare the risk of reported adverse events between hysteroscopic and laparoscopic sterilization.Design, setting, and participantsFrench nationwide cohort study using the national hospital discharge database linked to the health insurance claims database. Women aged 30 to 54 years receiving a first hysteroscopic or laparoscopic sterilization between 2010 and 2014 were included and were followed up through December 2015.ExposuresHysteroscopic sterilization vs laparoscopic sterilization.Main outcomes and measuresRisks of procedural complications (surgical and medical) and of gynecological (sterilization failure that includes salpingectomy, second sterilization procedure, or pregnancy; pregnancy; reoperation) and medical outcomes (all types of allergy; autoimmune diseases; thyroid disorder; use of analgesics, antimigraines, antidepressants, benzodiazepines; outpatient visits; sickness absence; suicide attempts; death) that occurred within 1 and 3 years after sterilization were compared using inverse probability of treatment-weighted Cox models.ResultsOf the 105 357 women included (95.5% of eligible participants; mean age, 41.3 years [SD, 3.7 years]), 71 303 (67.7% ) underwent hysteroscopic sterilization, and 34 054 (32.3%) underwent laparoscopic sterilization. During the hospitalization for sterilization, risk of surgical complications for hysteroscopic sterilization was lower: 0.13% for hysteroscopic sterilization vs 0.78% for laparoscopic sterilization (adjusted risk difference [RD], -0.64; 95% CI, -0.67 to -0.60) and was lower for medical complications: 0.06% vs 0.11% (adjusted RD, -0.05; 95% CI, -0.08 to -0.01). During the first year after sterilization, 4.83% of women who underwent hysteroscopic sterilization had a higher risk of sterilization failure than the 0.69% who underwent laparoscopic sterilization (adjusted hazard ratio [HR], 7.11; 95% CI, 5.92 to 8.54; adjusted RD, 4.23 per 100 person-years; 95% CI, 3.40 to 5.22). Additionally, 5.65% of women who underwent hysteroscopic sterilization required gynecological reoperation vs 1.76% of women who underwent laparoscopic sterilization (adjusted HR, 3.26; 95% CI, 2.90 to 3.67; adjusted RD, 4.63 per 100 person-years; 95% CI, 3.38 to 4.75); these differences persisted after 3 years, although attenuated. Hysteroscopic sterilization was associated with a lower risk of pregnancy within the first year of the procedure but was not significantly associated with a difference in risk of pregnancy by the third year (adjusted HR, 1.04; 95% CI, 0.83-1.30; adjusted RD, 0.01 per 100 person-years; 95% CI, -0.04 to 0.07). Risks of medical outcomes were not significantly increased with hysteroscopic sterilization compared with laparoscopic sterilization.Conclusions and relevanceAmong women undergoing first sterilization, the use of hysteroscopic sterilization was significantly associated with higher risk of gynecological complications over 1 year and over 3 years than was laparoscopic sterilization. Risk of medical outcomes was not significantly increased over 1 year or over 3 years. These findings do not support increased medical risks associated with hysteroscopic sterilization.

Project description:Female sterilization is the second most commonly used method of contraception in the United States. Female sterilization can now be performed through laparoscopic, abdominal, or hysteroscopic approaches. The hysteroscopic sterilization may be a safer option than sterilization through laparoscopy or laparotomy because it avoids invading the abdominal cavity and undergoing general anaesthesia. Hysteroscopic sterilization mainly includes chemical agents and mechanical devices. Common issues related to the toxicity of the chemical agents used have raised concerns regarding this kind of contraception. The difficulty of the transcervical insertion of such mechanical devices into the fallopian tubes has increased the high incidence of device displacement or dislodgment. At present, Essure® is the only commercially available hysteroscopic sterilization device being used clinically. The system is irreversible and is not effective immediately.Our new hysteroscopic sterility system consists of nickel-titanium (NiTi) shape memory alloy and a waterproof membrane. The NiTi alloy is covered with two coatings to avoid toxic Ni release and to prevent stimulation of epithelial tissue growth around the oviducts. Because of the shape memory effect of the NiTi alloy, the device works like an umbrella: it stays collapsed at low temperature before placement and opens by the force of shape memory activated by the body temperature after it is inserted hysteroscopically into the interstitial tubal lumen. The rim of the open device will incise into interstitial myometrium during the process of unfolding. Once the device is fixed, it blocks the tube completely. When the patient no longer wishes for sterilization, the device can be closed by perfusing liquid with low temperature into the uterine cavity, followed by prospective hysteroscopic removal. After the device removal, the fallopian tube will revert to its physiological functions.Currently, experimental and clinical studies are needed to attest the safety, efficiency and reversibility of the novel sterilization device.If our hypothesis is confirmed, appropriate and reversible contraceptive can be achieved with the device we have designed, which may have significant repercussions for numerous women worldwide.

Project description:ImportancePatients with a surgically managed fracture are commonly discharged from the hospital with a strong opioid prescription, but limited evidence exists to support this practice.ObjectiveTo test the hypothesis that strong opioids provide greater analgesia than mild opioids over the first week postdischarge from hospital after fracture surgical treatment.Design, setting, and participantsThis double-blind, superiority, randomized clinical trial was conducted at a single-center, major trauma hospital in Sydney, Australia. Participants were inpatients who had sustained an acute nonpathological facture of a long bone or the pelvis, patella, calcaneus, or talus who were treated with surgical fixation and enrolled from July 27, 2016, to August 22, 2017. Data were analyzed from June through October 2018.InterventionsInitiation at discharge of oxycodone hydrochloride 5 mg of 10 mg (ie, 1 or 2 tablets) or combination acetaminophen and codeine 500 mg and 8 mg or 1000 mg and 16 mg (ie, 1 or 2 tablets) 4 times daily for a maximum duration of 3 weeks.Main outcomes and measuresThe primary outcome was the mean of daily pain scores collected during week 1 of treatment measured using the Numerical Pain Rating Scale (NRS). Participants were asked to rate their mean pain over the previous 24 hours daily using an NRS score from 0 to 10, with 0 representing no pain and 10 representing the worst pain imaginable. The key secondary outcomes were EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) responses, worst pain, medication adverse events, global perceived effect, and return to work.ResultsA total of 120 patients with 1 or more acute orthopedic fractures requiring surgical fixation were randomized, including 59 patients in the strong-opioid group (43 [72.9%] men; mean [SD] age, 36.0 [14.1] years; mean oral morphine equivalent for days 1-7 of 32.9 mg) and 61 patients in the mild opioid group (47 [77.1%] men; mean [SD] age, 38.2 [13.5] years; mean oral morphine equivalent for days 1-7 of 5.5 mg). From days 1 to 7 postdischarge, the mean daily NRS mean pain score was 4.04 (95% Cl, 3.67 to 4.41) in the strong opioid group and 4.54 (95% Cl, 4.17 to 4.90) in the mild opioid group. The between-group difference of the primary outcome was not statistically significant (-0.50 [95% Cl, -1.11 to 0.12]; P = .11) despite a 6-fold increased dose of opioids being delivered in the strong opioid group.Conclusions and relevanceThis study found that treatment with strong opioid medication subacutely was not superior to treatment with milder medication for treatment of pain among patients with surgically managed orthopedic fractures. These findings suggest that ongoing first-line strong opioid use after discharge from the hospital should not be supported.Trial registrationAustralia New Zealand Clinical Trial Registry No.: ACTRN12616000941460.

Dataset Information

Incidence of opioid-managed pelvic pain after hysteroscopic sterilization versus laparoscopic sterilization, US 2005-2012.

Publications

Incidence of opioid-managed pelvic pain after hysteroscopic sterilization versus laparoscopic sterilization, US 2005-2012.

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