Anesthesia on Postoperative Pain After Loop Electrosurgical Excision Procedure

Not Applicable

Completed

• Conditions: Procedure, Gynecologic Surgical
• Interventions: Procedure: LEEP

• Registration Number: NCT04984122
• Lead Sponsor: Erzincan Military Hospital

Brief Summary

The loop electrosurgical excision procedure (LEEP) is a modified cervical conization that is performed with an electrosurgical loop. It may be performed under local anesthesia (LA) or under general anesthesia (GA), and practice patterns differ widely. In some countries, specific guidelines for the choice of anesthesia during LEEP are provided, whereas, in other countries, the choice of anesthesia is not specified. LEEP under LA is more economical, obviating the need for anesthesia staff, equipment, and operating room fees. However, LEEP under LA may be more difficult to perform, may be more difficult to learn, may lead to inferior surgical results, and may result in more pain and patient dissatisfaction. This study aimed to compare loop electrosurgical excision procedures under local anesthesia vs general anesthesia regarding patients' satisfaction, histopathologic results, and short-term morbidity

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-25
• Study First Submitted QC: 2021-07-25
• Study First Posted: 2021-07-30
• Study Start: 2021-08-09
• Primary Completion: 2022-04-30
• Study Completion: 2022-08-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-02
• Last Update Posted: 2023-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 248

Inclusion Criteria

Patients were > 21 years old; were not pregnant

The patient had one of the following indications for LEEP:

1. histologyproven, persistent, low-grade squamous intraepithelial lesion (LGSIL);
2. a histology-proven high-grade squamous intraepithelial lesion (HGSIL);
3. discrepancies between cytological reports and colposcopic impressions;
4. investigation for unsatisfactory colposcopy;
5. microinvasion or adenocarcinoma in situ on cervical punch biopsy.

Exclusion Criteria

Patients with cervical or vaginal infection; Patients with an abnormal menstrual cycle; who were taking anticoagulants, Patients with a coagulation defect Patients with mental incapacity Patients with previous hysterectomy with removal of the cervix Patients with a history of cervical cancer.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study	LEEP	In the LA group, after positioning of the patient, 50 mg of lidocaine spray (5 pumps, 10 mg in each pump) were applied to the ectocervix, then 2 mL bupivacaine hydrochloride was injected submucosally using a 27-gauge needle tip at the 3, 6, 9, and 12 o'clock locations in the ectocervix.
Control	LEEP	GA group intravenous 2-3 μ/kg fentanyl followed by 2 mg/kg propofol. were administered for anesthesia induction. After a laryngeal mask insertion anesthesia was maintained by inhalation of sevoflurane in an oxygen (60%) and nitrous oxide (40%) mixture to maintain a minimal alveolar concentration (MAC) of 0.8%-1.3%.

Primary Outcome Measures

Name	Time	Method
visual analog scale 1	up to 1 hour after the procedure	VAS score ( 0 cm = no pain, 10 cm = worst pain imaginable) reported for the pain felt at 1 hour after procedure.

Secondary Outcome Measures

Name	Time	Method
visual analog scale 2	up to 2 hour after the procedure	VAS score ( 0 cm = no pain, 10 cm = worst pain imaginable) reported for the pain felt at 2 hours after LEEP

Trial Locations

Locations (2)

Mugla Sıtkı Kocman University Education and Research Hospital; 🇹🇷 Mugla, Turkey

Kemal Gungorduk; 🇹🇷 Muğla, Turkey