By Rebecca H. Allen, MD, MPH, Editor
SYNOPSIS: In this randomized controlled trial comparing local anesthesia and general anesthesia for loop electrosurgical excision procedure of the cervix, there was no difference in patient satisfaction. However, women in the local anesthesia group had significantly smaller cone volumes and less blood loss than those in the general anesthesia group.
SOURCE: Rezniczek GA, Hecken JM, Rehman S, et al. Syringe or mask? Loop electrosurgical excision procedure under local anesthesia: A randomized trial. Am J Obstet Gynecol 2020;223:888.e1-888.e9.
This randomized controlled trial was conducted from July 2018 to February 2020 in Germany. All women presenting for loop electrosurgical excision procedure (LEEP) of the cervix were offered participation. Exclusion criteria included pregnancy, prior LEEP or conization, language barrier, concomitant oncological disease, known thrombophilia, or anticoagulant use. In the local anesthesia group, the cervix was injected with 2 mL of 0.5% bupivacaine at the two o’clock, four o’clock, seven o’clock, and 11 o’clock positions without any vasoconstrictor and one minute was allowed for the anesthesia to take effect.
The transformation zone was graded into three types: type 1 (fully visible), type 2 (partially visible), and type 3 (not visible; dilute acetic acid was used to identify the lesion). The LEEP was performed with the electrocautery on full cut and bypassing the loop from top (12 o’clock) to bottom (six o’clock). Any fragmentation of the specimen was noted. No endocervical curettage was performed, and hemostasis was obtained with a ball electrode. In the general anesthesia group, anesthesia was induced by intravenous fentanyl. Propofol and a laryngeal mask airway was inserted using sevoflurane for maintenance. Only three surgeons performed the procedure. Previous to this study, LEEPs were performed only under general anesthesia at this institution; therefore, each surgeon performed three LEEPs under local anesthesia for training prior to study initiation. The primary endpoint was patient satisfaction on the day of surgery and two weeks after surgery, assessed on a scale of 0 to 10. Other data collected included pain level after surgery on a scale of 0 to 10, margin status, cone volume, intraoperative blood loss measured by change in hemoglobin between the day before the LEEP and four to five hours after the LEEP, procedure time, complications, bleeding after surgery, and satisfaction of the surgeon.
The authors approached 229 women for the study. Five did not meet inclusion criteria, seven declined to participate, and nine were used for training LEEPs, leaving 208 women to be randomized. The majority of subjects were undergoing LEEP for a high-grade biopsy of the cervix. In the intention to treat analysis, there was no difference in patient satisfaction immediately after the surgery (100 vs. 100; P = 0.077) nor in pain level after surgery (10 local anesthesia vs. 20 general anesthesia; P = 0.75). Two weeks after surgery, there was no difference in patient satisfaction, pain level on the first day, duration of pain, and bleeding severity on the first day. However, subjects in the local anesthesia group reported significantly fewer total days of bleeding (7.5 vs. 13; P = 0.026) compared to the general anesthesia group. Similar proportions would choose the same type of anesthesia again (84% local anesthesia vs. 82% general anesthesia; P = 0.179).
However, 15 patients randomized to local anesthesia crossed over to the general anesthesia group because of fear of pain. Therefore, in the per-protocol analysis, positive margins were present in 6.6% of the local anesthesia group and 2.1% of the general anesthesia group (P = 0.258). Cone volume was significantly less in the local anesthesia group compared to the general anesthesia group (1.11 cm3 vs. 1.58 cm3; P = 0.001). Fragmentation was similar (12% local anesthesia vs. 6.4% general anesthesia; P = 0.276), as was procedure duration (151.5 seconds local anesthesia vs. 180 seconds general anesthesia; P = 0.342). Change in hemoglobin was lower at 0.2 in the local anesthesia group compared to 0.5 in the general anesthesia group, P = 0.001. There was no significant difference in adverse effects or complication rates between the two groups. In a multivariable analysis of patient satisfaction, only parity, type of transformation zone, and cone volume influenced patient satisfaction, but study group allocation did not.
COMMENTARY
LEEP conization of the cervix is one of the most common methods to treat cervical dysplasia worldwide.1 The authors of this study wanted to compare, in a randomized fashion, local anesthesia to general anesthesia for LEEP procedures, given that practice patterns vary across gynecologists, hospitals, and countries. According to the authors, LEEP is more commonly performed under local anesthesia in English-speaking countries (e.g., the United States, the United Kingdom, and Australia) and more commonly under general anesthesia in Europe and Asia. The organization that guides colposcopy practice in the United States, the American Society for Colposcopy and Cervical Pathology (ASCCP), does not specify guidelines for LEEP procedures or anesthesia choice.
The authors chose to focus on patient satisfaction as their primary outcome and did not find much of a difference. However, they did find significantly smaller cone volumes in the local anesthesia arm. I suspect this might be the result of surgeon concern over patient comfort during the procedure, perhaps in terms of hesitating to perform a larger cone in the local anesthesia subjects. However, it is possible that this could be because of the fact that the surgeons in this study had performed only three LEEPs under local anesthesia prior to beginning the study protocol. The smaller cone volumes could be either an advantage in terms of future childbearing or a disadvantage in terms of margin status and fragmentation. Although there was no statistical difference between the two groups in terms of these variables, there was a trend toward more positive margins and more fragmentation of the specimen in the local anesthesia group. The decreased blood loss as measured by the change in hemoglobin and the shorter duration of bleeding post-procedure in the local anesthesia group also could be directly related to the cone volume. Given that the usual practice in the authors’ home country is general anesthesia, they concluded that local anesthesia was a safe and effective alternative associated with similar levels of patient satisfaction.
One component of this study that makes it less generalizable to the United States is that endocervical curettage was not performed after the LEEP. This often is a component of LEEPs in the United States to ascertain the superior margin and it may add more discomfort to the procedures under local anesthesia. Additionally, a vasoconstrictor agent was not used at all, which often is done in the United States for both local anesthesia patients and women undergoing procedures under general anesthesia for purposes of hemostasis.2 Nevertheless, the fact that the study was randomized is a significant strength. It is impressive that the investigators were able to randomize so many participants to vastly different types of anesthesia. I doubt this would be feasible in the United States. Interestingly, only 15 women crossed over from local anesthesia to general anesthesia because of fear of pain.
In many U.S. practices, local anesthesia is the standard of care because of decreased costs and increased efficiencies in practice compared to general anesthesia, which requires an outpatient surgicenter or hospital operating room.2 Patient selection for local anesthesia in the office is important. Frequently, patients may opt for higher levels of anesthesia because of anxiety and fear of pain. The surgeon may opt for general anesthesia as a result of the anticipated difficulty of the procedure. In our practice, patients generally are given the choice of an office procedure or a procedure in the operating room if they are deemed a candidate for an office procedure based on their anatomy, visualization, size of the lesion, and ability to cooperate with the procedure. Therefore, although this study is reassuring that patients will be satisfied with either method of anesthesia, I do not see the results changing my current clinical practice.
REFERENCES
- Santesso N, Mustafa RA, Schunemann HJ, et al. World Health Organization guidelines for treatment of cervical intraepithelial neoplasia 2-3 and screen-and-treat strategies to prevent cervical cancer. Int J Gynaecol Obstet 2016;132:252-258.
- Pierce JG Jr., Bright S. Performance of a colposcopic examination, a loop electrosurgical procedure, and cryotherapy of the cervix. Obstet Gynecol Clin North Am 2013;40:731-757.
