Anesthesia on Postoperative Pain After Loop Electrosurgical Excision Procedure

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

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

Study Overview

• Status: Completed
• Conditions: Procedure, Gynecologic Surgical
• Intervention / Treatment: Procedure: LEEP

• Study Type: Interventional
• Enrollment (Actual): 248
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Mugla, Turkey, 48000
    • Mugla Sıtkı Kocman University Education and Research Hospital
  • Muğla, Turkey, 35460
    • Kemal Güngördük

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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%.	Procedure: 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.
Other: 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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Erzincan Military Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2021
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: July 25, 2021
• First Submitted That Met QC Criteria: July 25, 2021
• First Posted (Actual): July 30, 2021

Study Record Updates

• Last Update Posted (Estimate): March 3, 2023
• Last Update Submitted That Met QC Criteria: March 2, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: MUGLA-5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No