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Syringe or mask? Loop electrosurgical excision procedure under local or general anesthesia: a randomized trial.
- Source :
-
American journal of obstetrics and gynecology [Am J Obstet Gynecol] 2020 Dec; Vol. 223 (6), pp. 888.e1-888.e9. Date of Electronic Publication: 2020 Jul 24. - Publication Year :
- 2020
-
Abstract
- Background: Loop electrosurgical excision procedure may be performed under local anesthesia or general anesthesia, and practice patterns differ worldwide. No randomized head-to-head comparison has been published to confirm or refute either practice.<br />Objective: This study aimed to compare loop electrosurgical excision procedure under local anesthesia vs general anesthesia regarding patient satisfaction and procedure-related outcomes such as rates of involved margins, complications, pain, and blood loss.<br />Study Design: Consecutive women referred to our colposcopy unit were recruited. Loop electrosurgical excision procedure was performed under local anesthesia with 4 intracervical injections of bupivacaine hydrochloride 0.5% or under general anesthesia with fentanyl, propofol, and a laryngeal mask with sevoflurane maintenance. The primary endpoint was patient satisfaction assessed on the day of surgery and 14 days thereafter using a Likert scale (score 0-100) and a questionnaire. Secondary endpoints included rates of involved margins, procedure-related complications, pain, blood loss, and surgeon preference. Results were compared using nonparametric and chi-square tests.<br />Results: Between July 2018 and February 2020, we randomized 208 women, 108 in the local anesthesia arm and 100 in the general anesthesia arm. In the intention-to-treat analysis, patient satisfaction did not differ between the study groups directly after surgery (Likert scale 100 [90-100] vs 100 [90-100]; P=.077) and 14 days thereafter (Likert scale 100 [80-100] vs 100 [90-100]; P=.079). In the per-protocol analysis, women in the local anesthesia arm had significantly smaller cone volumes (1.11 cm <superscript>3</superscript> [0.70-1.83] vs 1.58 cm <superscript>3</superscript> [1.08-2.69], respectively; P<.001), less intraoperative blood loss (Δhemoglobin, 0.2 g/dL [-0.1 to 0.4] vs 0.5 g/dL [0.2-0.9]; P<.001), and higher satisfaction after 14 days (100 [90-100] vs 100 [80-100]; P=.026), whereas surgeon preference favored general anesthesia (90 [79-100] vs 100 [90-100], respectively; P=.001). All other secondary outcomes did not differ between groups (resection margin status R1, 6.6% vs 2.1% [P=.26]; cone fragmentation, 12.1% vs 6.3% [P=.27]; procedure duration, 151.5 seconds [120-219.5] vs 180 seconds [117-241.5] [P=.34]; time to complete hemostasis, 60 seconds [34-97] vs 70 seconds [48.25-122.25] [P=.08]; complication rate, 3.3% vs 1.1% [P=.59]). In a multivariate analysis, parity (P=.03), type of transformation zone (P=.03), and cone volume (P=.02) and not study group assignment, age, body mass index, and degree of dysplasia independently influenced the primary endpoint.<br />Conclusion: Loop electrosurgical excision procedure under local anesthesia is equally well tolerated and offers patient-reported and procedure-related benefits over general anesthesia, supporting the preferred practice in some institutions and refuting the preferred practice in others.<br /> (Copyright © 2020 Elsevier Inc. All rights reserved.)
- Subjects :
- Adenocarcinoma in Situ pathology
Adenocarcinoma in Situ surgery
Adult
Anesthetics, Inhalation therapeutic use
Anesthetics, Intravenous therapeutic use
Anesthetics, Local therapeutic use
Anxiety
Attitude of Health Personnel
Blood Loss, Surgical
Bupivacaine therapeutic use
Carcinoma, Squamous Cell pathology
Carcinoma, Squamous Cell surgery
Conization methods
Female
Fentanyl therapeutic use
Gynecology
Humans
Laryngeal Masks
Margins of Excision
Pain, Postoperative physiopathology
Pain, Procedural
Postoperative Complications
Postoperative Hemorrhage
Propofol therapeutic use
Sevoflurane therapeutic use
Squamous Intraepithelial Lesions of the Cervix pathology
Squamous Intraepithelial Lesions of the Cervix surgery
Surgeons
Uterine Cervical Dysplasia pathology
Uterine Cervical Neoplasms pathology
Anesthesia, General methods
Anesthesia, Local methods
Colposcopy methods
Electrosurgery methods
Patient Satisfaction
Uterine Cervical Dysplasia surgery
Uterine Cervical Neoplasms surgery
Subjects
Details
- Language :
- English
- ISSN :
- 1097-6868
- Volume :
- 223
- Issue :
- 6
- Database :
- MEDLINE
- Journal :
- American journal of obstetrics and gynecology
- Publication Type :
- Academic Journal
- Accession number :
- 32585223
- Full Text :
- https://doi.org/10.1016/j.ajog.2020.06.041