I LEIOMYOMAS ^580

Uterine leiomyomas (commonly known as fibroids) are the most com­mon solid pelvic tumors in women and the leading indication for hys­terectomy. When including direct costs, lost work-hour costs, and costs related to obstetric complications, uterine leiomyomas are estimated to cost the United States $5.9-34.4 billion annually.

Diagnosis

Leiomyomas are asymptomatic in most women and are an incidental find­ing on pelvic examination. Among women who seek treatment for their symptoms, abnormal genital bleeding and pelvic pressure are the most common. In affected women, not all abnormal bleeding is caused by the leiomyomas; therefore, other causes of abnormal bleeding in the pres­ence of leiomyomas should be ruled out (see also the “Abnormal Genital Bleeding” section earlier in Part 4). A number of tests may be used to confirm the diagnosis, including ultrasonography, hysteroscopy, hystero- salpingography, sonohysterography, and laparoscopy. Imaging tests, such as magnetic resonance imaging and computed tomography, may be used but rarely are needed.

Management

Treatment options for leiomyomas should be based on the type and sever­ity of symptoms, the size and location of the leiomyomas, and the patient’s age and future reproductive plans. Uterine leiomyomas are usually benign and do not appear to have a malignant potential. As benign neoplasms, uterine leiomyomas usually require treatment only when they cause symp­toms, lead to urinary obstruction, or appear to contribute to infertility.

Uterine size and symptoms may regress after menopause. Postmeno­pausal women with leiomyomas may have more bleeding problems, and some leiomyomas increase in size while hormone therapy is taken. How­ever, there appears to be no reason to withhold this treatment from women who desire or need such therapy.

Medical Interventions

Medical therapies for leiomyomas include contraceptive steroids, gonado­tropin-releasing hormone (GnRH) agonists, GnRH antagonists, aromatase inhibitors, and progesterone modulators.

Contraceptive Steroids

The use of hormonal contraceptive agents or hormone therapy (proges­tins alone or in combination with estrogen) may be useful for symptoms related to abnormal menstruation. However, treatment with contraceptive steroids tends to give only short-term relief, and the crossover rate to surgi­cal therapies is high.

Gonadotropin-Releasing Hormone Agonists

Gonadotropin-releasing hormone agonists have been used to treat uter­ine leiomyomas. Their use preoperatively is beneficial, especially when improvement of hematologic status and reduction in size of the uterus are important goals. These agents usually are given 2-3 months preop- eratively. Benefits of the use of GnRH agonists should be weighed against the cost and adverse effects for individual patients. Long-term use of these agents usually is not recommended. The use of steroid hormones as add- back therapy to attenuate bone loss has produced reasonable results and allowed longer treatment regimens. However, much of the reduction in uterine volume is regained by 24 months when add-back therapy is used (see also the “Endometriosis” section earlier in Part 4).

Gonadotropin-Releasing Hormone Antagonists

Although not approved by the U.S. Food and Drug Administration (FDA) for preoperative treatment of leiomyomas, GnRH antagonists have the advantage of not inducing an initial steroidal flare as seen with GnRH agonists.

Aromatase Inhibitors and Progesterone Modulators

Aromatase inhibitors and progesterone modulators have been found to be beneficial in small studies and case reports, although they are not FDA approved for the treatment of leiomyomas. Overall, few data exist about the use of these medications to treat uterine leiomyomas, and further research is necessary to elucidate their clinical use.

Surgical Interventions

Surgical options for treatment of leiomyomas include myomectomy, uter­ine artery embolization, endometrial ablation, magnetic resonance imag­ing-guided focused ultrasound surgery, and hysterectomy. Many women seek an alternative to hysterectomy for a variety of reasons, including a desire to preserve childbearing potential. As alternatives to hysterectomy become increasingly available, the efficacies of these treatments and their risks and potential problems become important considerations.

Myomectomy

Abdominal myomectomy is a safe and effective option for women who wish to retain their uterus. A woman who selects this option should be counseled preoperatively about the relatively high risk of reoperation. Laparoscopic myomectomy appears to be a safe and effective option for women with a small number of moderately-sized uterine leiomyomas. Hysteroscopic myomectomy is effective for controlling heavy menstrual bleeding in women with submucosal leiomyomas. The use of vasopressin at the time of myomectomy appears to limit blood loss.

Leiomyomas may be a factor in infertility for some patients and are pres­ent in as many as 5-10% of infertile couples. The issues are complex, and myomectomy should not be performed solely for an infertility indication without completion of a comprehensive fertility evaluation.

Uterine Artery Embolization

Uterine artery embolization for the treatment of patients with symptomatic uterine leiomyomas has become increasingly popular.

Endometrial Ablation

Endometrial ablation appears to be effective in controlling heavy men­strual bleeding in women with submucosal leiomyomas measuring up to 3 cm in diameter. For women with larger submucosal leiomyomas and heavy menstrual bleeding, hysteroscopic resection can be combined with endometrial ablation.

Magnetic Resonance Imaging-Guided Focused Ultrasound Surgery Magnetic resonance imaging-guided focused ultrasound surgery was approved by the FDA in 2004. It has been shown to be safe and moderately effective in short term-studies, but data on outcomes beyond 24 months are limited.

Hysterectomy

In women with symptomatic leiomyomas, hysterectomy provides a defini­tive cure. Approximately 600,000 hysterectomies are performed each year in the United States.

Bibliography

Alternatives to hysterectomy in the management of leiomyomas. ACOG Practice Bulletin No. 96. American College of Obstetricians and Gynecologists. Obstet Gynecol 2008;112:387-400. [PubMed] [Obstetrics & Gynecology]

Cardozo ER, Clark AD, Banks NK, Henne MB, Stegmann BJ, Segars JH. The estimat­ed annual cost of uterine leiomyomata in the United States. Am J Obstet Gynecol 2012;206:211.e1-9. [PubMed] [Full Text]

Endometrial ablation. ACOG Practice Bulletin No. 81. American College of Obstetricians and Gynecologists. Obstet Gynecol 2007;109:1233-48. [PubMed] [Obstetrics & Gynecology]

Gupta JK, Sinha A, Lumsden MA, Hickey M. Uterine artery embolization for symp­tomatic uterine fibroids. Cochrane Database of Systematic Reviews 2012, Issue 5. Art. No.: CD005073. DOI: 10.1002∕14651858.CD005073.pub3. [PubMed] [Full Text] Myomas and reproductive function. Practice Committee of American Society for Reproductive Medicine in collaboration with Society of Reproductive Surgeons. Fertil Steril 2008;90:S125-30.

Sharp HT. Assessment of new technology in the treatment of idiopathic menor­rhagia and uterine leiomyomata. Obstet Gynecol 2006;108:990-1003. [PubMed] [Obstetrics & Gynecology]

Supracervical hysterectomy. ACOG Committee Opinion No. 388. American College of Obstetricians and Gynecologists. Obstet Gynecol 2007;110:1215-7. [PubMed] [Obstetrics & Gynecology]

Resource

American College of Obstetricians and Gynecologists. Uterine fibroids. ACOG Patient Education Pamphlet AP074. Washington, DC: ACOG; 2009.

■ ACUTE AND CHRONIC PAIN

MANAGEMENT ^338 ^523 ^586 ^627

The heterogeneous patient population cared for by obstetricians and gyne­cologists results in a broad range of pain management challenges. The pain experienced by gynecologic patients ranges from acute pain, such as postoperative incisional pain, to chronic pain, such as chronic pelvic pain and pain experienced by many patients with cancer. Although the treat­ment of patients with acute postoperative pain is typically less challenging than the long-term management of chronic pain syndromes, studies have shown that even this acute pain often is not controlled optimally. Many patients respond adequately to the as-needed administration of an opioid, such as morphine or meperidine, whereas other patients require alternative medications, modification of the dosage, or different routes of administra­tion to achieve optimal results. Studies have documented that 25-70% of general surgical patients have unrelieved postoperative pain. Surveys of patients with chronic cancer pain have documented that approximately two thirds of these patients also have acute pain transiently. It is clear that even though the treatments required to provide adequate relief of pain are widely available, they often are not used adequately. The fear of regulatory scrutiny is the most common reason physicians give for failing to provide adequate medication for chronic pain.

Pain Management Guidelines and Quality­indicators

One of the first quality improvement programs for pain management was developed by the American Pain Society in 1995. These quality improve­ment guidelines for the treatment of acute pain and cancer pain were refined and expanded in 2005 based on a systematic review of pain man­agement quality improvement studies (Box 4-1). The emphasis has shifted from processes to outcomes.

Box 4-1. American Pain Society's Pain Management Guidelines and Quality Indicators ^

Guidelines

• Recognize and treat pain promptly

• Involve patients and families in pain management plan

• Improve treatment patterns

• Reassess and adjust pain management plan as needed

• Monitor processes and outcomes of pain management

Quality Indicators

Quality indicators focus on appropriate use of analgesics and outcomes:

• Intensity of pain is documented using a numeric (0-10) or descriptive (mild, moderate, severe) rating scale

• Pain intensity is documented at frequent intervals

• Pain is treated by route other than intramuscular

• Pain is treated with regularly administered analgesics, and when possible, multimodal approach. (Includes a combination of pain control strategies, such as opioids, nonsteroidal antiinflammatory drugs, and nonpharmaco- logic interventions.)

• Pain is prevented and controlled to a degree that facilitates function and quality of life

• Patients are adequately informed and knowledgeable about pain management

Data from Gordon DB, Dahl JL, Miaskowski C, McCarberg B, Todd KH, Paice JA, et al. American pain society recommendations for improving the quality of acute and can­cer pain management: American Pain Society Quality of Care Task Force. Arch Intern Med 2005;165:1574-80 and Gordon DB, Pellino TA, Miaskowski C, McNeill JA, Paice JA, Laferriere D, et al. A 10-year review of quality improvement monitoring in pain man­agement: recommendations for standardized outcome measures. Pain Manag Nurs 2002;3:116-30.

Many hospitals have established comprehensive pain services, which often are directed by anesthesiologists and provide expert assessment and multimodality therapy for patients with acute and chronic pain. They should be used especially for patients who have a history of difficult-to­manage pain in the perioperative setting or for patients who may have a neurologic component to their pain.

The Joint Commission provides standards on pain assessment and treatment for accredited ambulatory care facilities, behavioral health care organizations, critical access hospitals, home care providers, hospitals, office-based surgery practices, and long-term health care providers. These standards address the assessment and management of pain and require organizations to do the following:

• Recognize the rights of patients to appropriate assessment and management of pain.

• Screen patients for pain during their initial assessment and, when clinically required, during ongoing, periodic reassessments.

• Educate patients suffering from pain and their families about pain management.

Approaches to Pain Management

The ability to manage pain optimally requires comprehensive assessment of pain and information regarding temporal characteristics (stable versus constant course, severity, location, quality, provocative factors, and pallia­tive factors). The clinician should be well versed in the various options for the management of pain. Whenever possible, therapy should be directed toward resolving the underlying condition.

Ideally, clinicians also should be familiar with the following approaches to pain management:

• Oral, intramuscular, and transdermal medications

— Nonsteroidal antiinflammatory medications

— Opioid medications

• Anesthesia administered

— Nerve blocks

— Continuous conduction anesthesia

• Neuromodulation

— Transcutaneous electrical nerve stimulation

— Acupuncture

— Massage

• Mood modification

— Aromatherapy

— Imagery

• Neurosurgery

The use of pain scales (eg, rating pain from 0 to 10) may be helpful. Clinicians also should be aware of the option for patient-controlled anal­gesia.

In general, nonsteroidal antiinflammatory drugs are overused and pro­vide minimal benefit to patients in severe acute and chronic pain, particu­larly patients experiencing pain secondary to metastatic cancer. Often these drugs are used instead of opioids with the concern that patients may become dependent. However, this class of medications generally does not control this pain, which can be severe, particularly at the end of life.

Guidelines for the treatment of patients with severe pain secondary to metastatic cancer suggest that long-acting opioids be administered around the clock and be supplemented with short-acting oral opioids for episodes of breakthrough pain. Opioid administration through oral, rectal, or transdermal routes can control 90% of cancer pain. Effective management requires recognition of drug pharmacokinetics and potential adverse effects that may be age-related.

Methods of neuromodulation, such as transcutaneous electrical nerve stimulation, acupuncture, and massage, are based on the gate theory of pain control. These treatments can be useful for pain control, particularly when the pain is severe. Imagery, aromatherapy, and other mood modifiers can provide an atmosphere of relaxation and comfort.

More invasive neurostimulation approaches to pain management may be used in patients with neuropathic pain that has been refractory to typical medical management. These approaches include peripheral nerve stimulation, nerve root stimulation, spinal cord stimulation, deep brain stimulation, and motor cortex stimulation. Use of these approaches has been validated for several conditions, including pelvic and perineal pain and chronic headache (peripheral nerve stimulation); pain secondary to brain lesions (deep brain stimulation); and chronic pain syndromes, such as failed back surgery syndrome (spinal cord stimulation). Consultation with pain management and neurosurgery specialists is imperative when considering these approaches.

Pain Management Legislation and Regulations

Clinicians should be familiar with any relevant pain treatment legisla­tion adopted in their state. They also should be aware of requirements regarding the use of controlled substances. For example, under the Food and Drug Administration Amendments Act of 2007, the U.S. Food and Drug Administration (FDA) has the authority to require a manufacturer to develop a risk evaluation and mitigation strategy when further mea­sures are needed to ensure that a drug’s benefits outweigh its risks. The 2012 risk evaluation and mitigation strategy for extended-release and long-acting opioid analgesics requires extended-release and long-acting opioid analgesic companies to make available training on proper prescrib­ing practices for health care providers who prescribe these analgesics and also to distribute educational materials to prescribers and patients on the safe use of these powerful pain medications. Health care providers should be aware of, and in compliance with, risk evaluation and mitiga­tion strategy requirements. Current risk evaluation and mitigation strategy information is available from the FDA web site (see www.fda.gov/Drugs/ DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ ucm111350.htm?utm_campaign=Google2&utm_source=fdaSearch&utm_ medium=website&utm_term=rems&utm_content=1). For more informa­tion on preventing prescription drug abuse, see the “Substance Use and Abuse” section in Part 3).

Bibliography

American Pain Society. Pain: current understanding of assessment, management, and treatments. Chicago (IL): APS; 2012. Available at: http://www.americanpain society.org/education/content/enduringmaterials.html. Retrieved July 31, 2013.

Current world literature. Curr Opin Anaesthesiol 2012;25:629-38. [PubMed]

Food and Drug Administration. Risk Evaluation and Mitigation Strategy (REMS) for extended-release and long-acting opioids. Available at: http://www.fda.gov/Drugs/ DrugSafety∕InformationbyDrugClass∕ucm163647.htm. Retrieved July 26, 2013.

Gordon DB, Dahl JL, Miaskowski C, McCarberg B, Todd KH, Paice JA, et al. American pain society recommendations for improving the quality of acute and cancer pain management: American Pain Society Quality of Care Task Force. Arch Intern Med 2005;165:1574-80. [PubMed] [Full Text]

Gordon DB, Pellino TA, Miaskowski C, McNeill JA, Paice JA, Laferriere D, et al. A 10-year review of quality improvement monitoring in pain management: recom­mendations for standardized outcome measures. Pain Manag Nurs 2002;3:116-30. [PubMed]

Optimizing the treatment of pain in patients with acute presentations. Policy statement. American Society for Pain Management Nursing (ASPMN), Emergency Nurses Association (ENA), American College of Emergency Physicians (ACEP), American Pain Society (APS). Ann Emerg Med 2010;56:77-9. [PubMed]

Quality improvement guidelines for the treatment of acute pain and cancer pain. American Pain Society Quality of Care Committee. JAMA 1995;274:1874-80. [PubMed]

The Joint Commission. Facts about pain management. Oakbrook Terrace (IL): Joint Commission; 2012. Available at: http://www.jointcommission.org/assets/1/18/ pain_management.pdf. Retrieved July 31, 2013.

Resources

Federation of State Medical Boards of the United States. Model policy for the use of controlled substances for the treatment of pain. Euless (TX): FSMB; 2004. Available at: http://www.fsmb.org/pdf/2004_grpol_Controlled_Substances.pdf. Retrieved July 31, 2013.

Food and Drug Administration. FDA blueprint for prescriber education for extended- release and long-acting opioid analgesics. Silver Spring (MD): FDA; 2013. Available at: http://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/ UCM277916.pdf. Retrieved August 9, 2013.

Management of endometriosis. Practice Bulletin No. 114. American College of Obstetricians and Gynecologists. Obstet Gynecol 2010;116:223-36. [PubMed] [Obstetrics & Gynecology]

Martino AM. In search of a new ethic for treating patients with chronic pain: what can medical boards do? J Law Med Ethics 1998;26:332-49, 263. [PubMed]

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National Vulvodynia Association. Vulvodynia treatment registry. Available at: http://www.nva.org/treatmentregistry.html. Retrieved August 9, 2013.

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