Office-Based Endometrial Cryoablation: Evaluating Anesthesia Considerations

Endometrial ablation offers a highly effective and lower-risk treatment alternative to a hysterectomy for patients suffering from heavy menstrual bleeding (HMB).¹ Due to the reduced pain and fewer complications associated with endometrial ablation, these procedures can be successfully performed in the office setting.1 Compared to a hospital or surgery center, the gynecology practice can be a favorable site of service, as the patient’s familiarity and comfort in the office may enhance her treatment experience and even improve her ablation outcomes (due to decreased preoperative anxiety).² In fact, 70% of women would opt for an office-based procedure if given the choice, according to market research.³

Endometrial cryoablations are especially suited for the office setting, as the cryotherapy used to gently freeze and dehydrate endometrial cells also delivers a natural analgesic effect during the procedure by numbing local sensory nerves.⁴ The Cerene Cryotherapy Device® specifically uses nitrous oxide to administer the cryotherapy treatment, creating a procedure that is not only safe and effective but also well-tolerated by patients.

The advantage of cryotherapy is that patients do not need general anesthesia or IV sedation to tolerate the procedure. While cryotherapy offers an effective solution for pain control for office-based ablations, OBGYNs may offer additional medications, including analgesics, anxiolytics, prostaglandin, and other forms of anesthesia, to maximize tolerability and ensure a positive treatment experience for their patients.

Seven Anesthesia Protocols Gynecologists Use to Administer Cerene Cryotherapy in the Office Setting

Cerene is a well-studied cryotherapy treatment in the office setting. According to a 2020 prospective clinical trial evaluating office-based Cerene Cryotherapy, over 97% of patients completed treatment without IV sedation (with 0% of patients needing general anesthesia).⁵ The following medication protocols were used:⁴

• 8.3% of cases only used a paracervical block (PCB)
• 19.8% of cases used a PCB with a non-steroidal anti-inflammatory drug (NSAID)
• 69% of cases used a PCB with an oral narcotic and/or anxiolytic

With the variety of medication combinations used for Cerene treatment, we consulted seven gynecologists who use Cerene Cryoablation in their practices to outline the different protocols that a physician could use to successfully provide cryotherapy in their practice.

Regimen 1: Howard Curlin, MD

Starting one to two hours before treatment, the patient takes 600 mg of Ibuprofen. Patients are not automatically given oral anxiolytics, but if they are feeling especially anxious about their procedure, they can take 5 mg of Valium or 1 mg of Ativan upon arrival. If the patient has a very narrow endocervix and/or a low pain tolerance, the gynecologist can administer 200 mcg of sublingual Misoprostol to help soften the cervix and potentially reduce pain when the Cerene device is routed through the cervix.

The anesthesia protocol begins with a PCB containing 10 cc of 1% plain (no Epinephrine) Lidocaine. The block is injected approximately 1 cm deep in two positions around the cervix: the 4-5 o’clock and the 7-8 o’clock positions. If the patient feels increased pain, the gynecologist can administer an additional 10 cc. Once the anesthetic is placed, the gynecologist should wait between one to two minutes before beginning the dilation process.

Regimen 2: Shannon Smith, MD

To help soften the cervix for the ablation treatment, all patients take 200 mcg of vaginal Misoprostol the night before their procedure. Patients also take 600 mg of Ibuprofen at this time. When the patient arrives at the office, she receives 15 mg of intramuscular Toradol approximately 15 to 20 minutes before treatment begins. This regimen does not include oral anxiolytics for any patients.

A PCB is the designated form of anesthesia in this regimen. The gynecologist administers 20 cc of 1% Lidocaine via the following protocol: 2 cc at 12 o’clock, 8 cc at 8 o’clock, and 10 cc at 4 o’clock. Once the block is injected, the gynecologist waits ten minutes before dilating the cervix.

Regimen 3: Gerard Reilly, MD

All patients are instructed to take 600 mg of Motrin the night before their procedure. If a patient has already mentioned concerns about low pain tolerance to her doctor, she may take the following combination of analgesics: one to two Percocet tablets and 10 mg of Phenergan one hour before treatment, as well as 30 mg of intramuscular Toradol as soon as they arrive to the office. All patients take 10 mg of Valium to help with any anxiety about the procedure.

Before the PCB is administered, the patient receives 0.4 mg of intramuscular Atropine or 0.2 mg of intramuscular Glycopyrrolate to lower the risk of a vagal response. After administering this first medication, the gynecologist injects a PCB with 20 cc of 1% Lidocaine in the following order: 2 cc at 12 o’clock, 8 cc at 8 o’clock, and 10 cc at 4 o’clock. The waiting period between anesthetic delivery and cervical dilation is ten minutes.

Regimen 4: Randall Kahan, MD

This medication protocol begins half an hour before treatment with Cerene Cryotherapy. 30 minutes before the procedure, the patient takes 1 mg of Xanax and three 200 mg Ibuprofen tablets. When the patient is 15 minutes away from the procedure, she is given 60 mg of intramuscular Toradol. No further anesthesia is used for the duration of the procedure.

Regimen 5: Richard Salter, MD

Both the night before and the morning of the procedure, the patient takes 200 mcg of Misoprostol (a total of 400 mcg). She is pretreated with 800 mg of Motrin 8 hours before the procedure, followed by one 7.5 mg hydrocodone tablet (for pain relief) and 2 mg of Valium (for preoperative anxiety) one hour before the procedure. The patient is given a PCB containing 10 mL of 2% Lidocaine with Epinephrine immediately before the Cerene treatment. At the end of the procedure, she receives 30 mg of intramuscular Toradol for postoperative pain relief.

Regimen 6: Douglas Gearity, MD

Similar to Regimen 5, this regimen instructs patients to take Misoprostol orally both the night before and the morning of the procedure — however, the doses are 400 mcg each, for a total of 800 mcg. When the patient arrives at the office, she receives 60 mg of intramuscular Toradol 15 minutes before treatment begins. For the PCB, the gynecologist injects 5 cc of Lidocaine at two positions — 4 o’clock and 8 o’clock — for a total of 10 cc. During the procedure, the patient receives nitrous gas to help with procedural anxiety and reduce any sensations of discomfort or pain.

Regimen 7: Non-Profit Academic Medical Center Physician

This regimen instructs the patient to take 400 mcg of Misoprostol for the two nights preceding her procedure to ensure successful cervical dilation. On the morning of the procedure, the patient takes 600 mg of Motrin. When the patient is prepped and ready for treatment, the gynecologist administers a PCB with 16 cc of 1% Lidocaine (no Epinephrine), waiting three to five minutes before beginning the dilation process.

(Note: Channel Medsystems does not recommend or endorse a specific anesthesia regimen to be used with the Cerene treatment. Be sure to take into consideration allergies, contraindications, and approved labeling for medication.)

Learn More About Using Cerene Cryotherapy in Your Office

With Cerene, gynecologists can provide a safe, office-based endometrial ablation procedure that achieves 90% patient satisfaction while maintaining patient tolerability and delivering a positive treatment experience.^† Find out how Cerene can benefit your practice and your patients at https://cerene.com/healthcare-professionals/.

† Patient-reported data are 1 year after treatment with durable results at 3 years

Key Takeaways:

• Because endometrial ablations are highly effective for HMB and pose fewer risks than hysterectomy, these procedures can be successfully performed in the office setting.1
• Cryotherapy is especially suited for an office-based procedure, as the cooling technology used to ablate endometrial tissue also delivers a natural pain-relieving effect during the procedure.
• This natural analgesic effect makes it possible to perform cryotherapy without general anesthesia, and gynecologists may use a variety of protocols to maximize procedural tolerability, including anxiolytics, analgesics, prostaglandin, and anesthetics.

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Sources

1. Kumar, V., Chodankar, R., Gupta, J.K. (2016). Endometrial Ablation for Heavy Menstrual Bleeding. Women’s Health (London) 12(1), 45-52.
2. Kassahun, W. T., Mehdorn, M., Wagner, T.C., Babel, J., Danker, H., & Gockel, I. (2022). The effect of preoperative patient-reported anxiety on morbidity and mortality outcomes in patients undergoing major general surgery. Scientific Reports, 12(1), 6312.
3. Data on file. Channel Medsystems Market Research Iris Survey 2014.
4. Cryotherapy vs. Heat-Based Thermal: Assessing Options for Endometrial Ablation Blog: https://cerene.com/cryotherapy-vs-heat-based-thermal-assessing-options-for-endometrial-ablation/
5. Curlin, H.L., Cintron, L.C., Anderson, T.L. (2021). A Prospective, Multicenter, Clinical Trial Evaluating the Safety and Effectiveness of the Cerene Device to Treat Heavy Menstrual Bleeding. Journal of Minimally Invasive Gynecology 28(4), 899-908.