Completed

NCT Number: NCT04984122

Anesthesia on Postoperative Pain After Loop Electrosurgical Excision Procedure

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

Completed

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Key information

Conditions

Procedure, Gynecologic Surgical

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kemal Gungorduk, Muğla, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

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.

Treatment and study plan

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.

Primary outcomes

visual analog scale 1

Time frame: 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 outcomes

visual analog scale 2

Time frame: 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

Sponsors and collaborators

Lead sponsor

Erzincan Military Hospital

Other

Registry information

Official study title

Influence of General and Local Anesthesia on Postoperative Pain After Loop Electrosurgical Excision Procedure: A Randomized Trial

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Jul 30, 2021
Registry last updated: Mar 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.