CClinicalTrials.gg
Status unknownNCT05706987anestheticsUpdated Feb 10, 2023

Lidocaine Improves Satisfaction in Labiaplasty

A Phase 4 interventional study of Lidocaine and Normal saline in Lidocaine, sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital. Status unknown at 1 site in Taiwan. Open to female participants aged 20 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-10.

Sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
Female
01

Study summary

1.Written informed consent must be obtained before any study specific procedures are undertaken.Qualified participants were identified at the pre-anesthesia evaluation clinic or ward.

2.80 patients with American Society of Anesthesiologists (ASA) score of I-II in our medical center scheduled to undergo elective surgery for hypertrophy of labia minor with MAC. Patients were randomized 1:1 into the Group 1 (normal saline) or Group 2 (lidocaine 1.5 mg/kg/hr, ideal body weight) by using a table of random, computer-generated digits in sealed and numbered envelopes by an anesthesiologist. All surgical procedure was performed by the same surgeon and the anesthetic data was recorded by a nurse anesthetist. All patients were fasted overnight before the procedure, and no medications were allowed before induction of anesthesia. Standard monitoring, such as non-invasive arterial blood pressure, electrocardiography (lead II), pulse oximetry, end-tidal carbon dioxide pressure (EtCO2) was applied for each patient. Participants were pre-oxygenated and adequately maintained with 100% oxygen at 3 L/min via a nasal cannula during the entire procedure. During anesthesia induction, all patients received intravenous fentanyl 0.5-1 mcg/kg, continuous infusion of propofol with target-controlled infusion (TCI; Fresenius Orchestra Primea; Fresenius Kabi AG, Bad Homburg, Germany) with the Ce of 4.0 mcg/mL and parecoxib. In addition, continuous infusion of equal volume normal saline and lidocaine 1.5 mg/kg/hr (ideal body weight) in group I and 2, respectively. In all patients, maintenance of the Ce of propofol was adjusted upward or downward by 0.5 mcg/mL to keep patient adequate sedation with acceptable pain (remaining moveless). If upward 2 times of propofol and the patient still move which affect the surgical procedure, fentanyl 0.5 mcg/kg was prescribed, and mean arterial pressure (MAP) and heart rate (HR) within baseline levels. As soon as the last suture, the propofol and lidocaine were discontinued. After the procedure, all patients were sent to the PACU for further care under clear consciousness.

Read the detailed description

Patients were monitored for MBP, HR, peripheral oxygen saturation (SpO2), respiratory rate (RR), EtCO2, Ce of propofol, BIS values, OAA/S at the T1: before anesthesia induction, T2: time of the skin incision, T3: 15 minutes after the skin incision, T4: 30 minutes after the skin incision, T5: 45 minutes after the skin incision, T6: time of the beginning skin suture, and T7: time of the end of procedure. Collected data also include the time that the surgery ended, the total usage of propofol and fentanyl, the frequency to adjustment of TCI, times of patient move affect the procedure, and the surgeon's satisfaction. At PACU, patients were monitored for HR, MBP, SpO2, RR, NRS, RASS, length of stay, PONV and patient satisfaction (scoring 1-5).

02

Conditions studied

  • Lidocaine

Keywords

  • Lidocaine
  • labiaplasty
03

In context

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital is the lead sponsor of 282 studies on the registry; 57 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Age between 20-80 years old
  2. ASA score I-II
  3. receiving labiaplasty

Exclusion criteria

Exclusion Criteria:

  1. age \< 20 years or older than 80 years
  2. ASA score more than II
  3. height \<152 and >213 cm
  4. body mass index > 35 kg/m2
  5. allergy to midazolam and lidocaine
  6. chronic use of opioid drugs
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    lidocaine infusion

    intravenous lidocaine infusion 1.5mg/kg/hr (ideal body weight) during labiaplasty

    Drug: Lidocaine

  • Placebo comparator
    normal saline infusion

    equal volume of normal saline infusion during labiaplasty

    Drug: Normal saline

Interventions

  • DrugLidocaine

    continuous lidocaine infusion perioperatively

  • DrugNormal saline

    normal saline

06

What researchers measure

Primary outcomes

  1. the alteration of total usage of propofol and fentanyl

    Comparing the treatment group with the control group the total infusion dose of propofol sedation and bolus intravenous fentanyl use perioperatively

    Time frame: about 1 hour (perioperatively)

Secondary outcomes

  1. the alterations of total adverse events

    Comparing the total adverse events caused by propofol sedation or fentanyl analgesics such as apnea or hypoxemia between the treatment and the control group

    Time frame: up to 1 hour

  2. postoperative patient's satisfaction after anesthesia

    Comparing the patient's satisfaction after anesthesia between the treatment group and the control group. The patient would be asked to score her satisfaction from 1-5, 1 as very dissatisfied, 2 as dissatisfied, 3 as neutral, 4 as satisfied and 5 as very satisfied.

    Time frame: 1 hour after the surgery.

  3. the surgeon's satisfaction after anesthesia service

    Comparing the surgeon's satisfaction after anesthesia service between the treatment group and the control group. The surgeon's satisfaction after anesthesia service would be calculated by scoring 1-5, 1 as very dissatisfied, 2 as dissatisfied, 3 as neutral, 4 as satisfied and 5 as very satisfied.

    Time frame: immediately after the surgery

07

Study locations

1 site
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
    Kaohsiung, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05706987
Lead sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Responsible party
Sponsor
First posted
Jan 31, 2023
Start date
Feb 15, 2023 (estimated)
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Feb 10, 2023

Study contacts

Zhi-Fu Wu, MD
Contact
aneswu@gmail.com
88673121111 ext. 7035
Zhi-Fu Wu, MD
study director · Kaohsiung Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion