Anesthesia on Postoperative Pain After Loop Electrosurgical Excision Procedure

NCT ID: NCT04984122

Last Updated: 2023-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 248 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-09
• Study Completion Date: 2022-08-31

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

Conditions

Procedure, Gynecologic Surgical

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

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%.

Group Type: OTHER

LEEP

Intervention Type: PROCEDURE

According to the size of the cervix, a loop electrode size was selected. The electrical power for the loop electrode was set to 50 W cut and 45 W coagulation in blended mode. LEEP was performed by carefully passing the loop around the transformation zone from 12 o'clock to 6 o'clock. An additional top-hat excision was performed in patients with a lesion deep in the cervical canal. After completion of the excision, hemostasis was exclusively obtained using the ball electrode in spray coagulation mode. No suturing or other methods were used for hemostasis.

Study

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.

Group Type: OTHER

LEEP

Intervention Type: PROCEDURE

According to the size of the cervix, a loop electrode size was selected. The electrical power for the loop electrode was set to 50 W cut and 45 W coagulation in blended mode. LEEP was performed by carefully passing the loop around the transformation zone from 12 o'clock to 6 o'clock. An additional top-hat excision was performed in patients with a lesion deep in the cervical canal. After completion of the excision, hemostasis was exclusively obtained using the ball electrode in spray coagulation mode. No suturing or other methods were used for hemostasis.

Interventions

LEEP

According to the size of the cervix, a loop electrode size was selected. The electrical power for the loop electrode was set to 50 W cut and 45 W coagulation in blended mode. LEEP was performed by carefully passing the loop around the transformation zone from 12 o'clock to 6 o'clock. An additional top-hat excision was performed in patients with a lesion deep in the cervical canal. After completion of the excision, hemostasis was exclusively obtained using the ball electrode in spray coagulation mode. No suturing or other methods were used for hemostasis.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Erzincan Military Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kemal GUNGORDUK

Medical Doctor - Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kemal Gungorduk

Muğla, , Turkey (Türkiye)

Mugla Sıtkı Kocman University Education and Research Hospital

Muğla, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

MUGLA-5

Identifier Type: -

Identifier Source: org_study_id