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Anesthesia on Postoperative Pain After Loop Electrosurgical Excision Procedure

Primary Purpose

Procedure, Gynecologic Surgical

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
LEEP
Sponsored by
Erzincan Military Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Procedure, Gynecologic Surgical

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Mugla Sıtkı Kocman University Education and Research Hospital
  • Kemal Gungorduk

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Control

Study

Arm Description

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%.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 25, 2021
Last Updated
March 2, 2023
Sponsor
Erzincan Military Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04984122
Brief Title
Anesthesia on Postoperative Pain After Loop Electrosurgical Excision Procedure
Official Title
Influence of General and Local Anesthesia on Postoperative Pain After Loop Electrosurgical Excision Procedure: A Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 9, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
August 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erzincan Military Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Procedure, Gynecologic Surgical

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
248 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Other
Arm Description
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%.
Arm Title
Study
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
LEEP
Intervention Description
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 Outcome Measure Information:
Title
visual analog scale 1
Description
VAS score ( 0 cm = no pain, 10 cm = worst pain imaginable) reported for the pain felt at 1 hour after procedure.
Time Frame
up to 1 hour after the procedure
Secondary Outcome Measure Information:
Title
visual analog scale 2
Description
VAS score ( 0 cm = no pain, 10 cm = worst pain imaginable) reported for the pain felt at 2 hours after LEEP
Time Frame
up to 2 hour after the procedure

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Mugla Sıtkı Kocman University Education and Research Hospital
City
Mugla
ZIP/Postal Code
48000
Country
Turkey
Facility Name
Kemal Gungorduk
City
Muğla
ZIP/Postal Code
35460
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Anesthesia on Postoperative Pain After Loop Electrosurgical Excision Procedure

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