Anesthesia on Postoperative Pain After Loop Electrosurgical Excision Procedure

NCT04984122 | Completed

• 1 other identifier: MUGLA-5
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• visual analog scale 1

  VAS score ( 0 cm = no pain, 10 cm = worst pain imaginable) reported for the pain felt at 1 hour after procedure.

  up to 1 hour after the procedure

Secondary Outcomes (1)

• visual analog scale 2

  up to 2 hour after the procedure

Study Arms (2)

Control

OTHER

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%.

Procedure: LEEP

Study

OTHER

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.

Procedure: LEEP

Interventions

LEEP 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.

Control; Study

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients were \> 21 years old; were not pregnant
• The patient had one of the following indications for LEEP:
• histologyproven, persistent, low-grade squamous intraepithelial lesion (LGSIL);
• a histology-proven high-grade squamous intraepithelial lesion (HGSIL);
• discrepancies between cytological reports and colposcopic impressions;
• investigation for unsatisfactory colposcopy;
• microinvasion or adenocarcinoma in situ on cervical punch biopsy.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erzincan Military Hospital: lead

Study Sites (2)

Kemal Gungorduk

Muğla, 35460, Turkey (Türkiye)

Location

Mugla Sıtkı Kocman University Education and Research Hospital

Muğla, 48000, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor - Professor

Study Record Dates

• First Submitted: July 25, 2021
• First Posted: July 30, 2021
• Study Start: August 9, 2021
• Primary Completion: April 30, 2022
• Study Completion: August 31, 2022
• Last Updated: March 3, 2023

Record last verified: 2023-03

Locations

TU (2)