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Efficacy and Safety of Electric Stimulation-guided Epidural Anesthesia for Cesarean Section

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ClinicalTrials.gov Identifier: NCT03443466
Recruitment Status : Recruiting
First Posted : February 23, 2018
Last Update Posted : February 23, 2018
Sponsor:
Collaborator:
Sewoon Medical Co., Ltd
Information provided by (Responsible Party):
Sang Sik Choi, Korea University Guro Hospital

Brief Summary:
Forty pregnant women (36 to 41 weeks gestation) will randomly allocate to two groups. Groups will be defined based on the method used to identify the epidural space for epidural anesthesia: the loss of resistance group (n=20) and the epidural electric stimulation group (n=20). Pain during the cesarean section will be assessed using a numerical visual analog scale and maternal satisfaction by a post-partum interview. The success rate of epidural anesthesia, maternal satisfaction, and neonatal Apgar scores will be compared between groups.

Condition or disease Intervention/treatment Phase
Epidural Anesthesia Device: Epidural electrical stimulation (EES) Device: Loss of resistance (LOR) Not Applicable

Detailed Description:

Investigators will place epidural catheter in the epidural space using loss of resistance technique, and will confirm correct placement of the epidural catheter using electric stimulation.

Epidural catheter placement, electric stimulation, and confirmation of response is followed:

Patients will be placed in the left lateral decubitus position. The site will be aseptically prepared and 1% lidocaine will be infiltrated to the skin. An 18-gauge Tuohy needle will be inserted midline of L4/5 interspinous space.

For the LOR group, after identification of the epidural space, the Tuohy needle will be stopped, and a 20-gauge epidural catheter will be advanced through the Touhy needle.

The same process will be followed for the EES group. In addition, the epidural space will be confirmed by epidural electric stimulation using a 20-gauge epidural catheter (RegionalStimTm, Sewoon Medical Co., Ltd, Seoul, Korea, 800 mm) with a conductive guidewire (conductive guidewire, Nitinol, 1100 mm).

After confirming there is no reverse flow of cerebrospinal fluid or blood with aspiration, 3 mL of 1% lidocaine, with 15 mcg of epinephrine (1:200000), will be injected through the epidural catheter as test dose. If there is no response to the test dose, patients will be moved to the operating room. In operating room, 20 mL of 2% lidocaine, 2 mL of bicarbonate (total volume 22 mL) will be administered in divided doses.

Blood pressure (BP), heart rate (HR), oxygen saturation (SpO2), and neurologic assessment findings will be monitored.

Pain relief in cesarean section is assessed in the visual analogue scale (VAS) score. A 10 point VAS, where 0 is no pain and 10 is unbearable pain, is used to assess pain during labor. The scale is assessed after epidural anesthesia. Differences in the VAS we used to assess the efficacy of the epidural anesthesia in decreasing labor pain. Comparison of the change in VAS between groups is used to compare pain control of the two methods. The success of epidural anesthesia is defined by sensory block, without motor block, and a decrease in pain score after adequate dosing of epidural medication. Failure of epidural anesthesia is defined in several ways. Objective outcome include conversion to general anesthesia, conversion to any different form of anesthesia, or pain during surgery.

Patient satisfaction will be evaluated by a postpartum interview. Satisfaction is graded between a score of 1-5, where 1 represent very unsatisfied and 5 represent very satisfied. Patients will indicate a score of 1 to 5.

One- and 5-minute Apgar scores will be compared to assess the effect of epidural electric stimulation on the neonate. Additional time required for epidural electric stimulation will be determined by the difference (in seconds) from LOR to identification of the epidural space through electric stimulation.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: None (Open Label)
Masking Description: No Masking
Primary Purpose: Treatment
Official Title: A Comparative Study of Success Rate, Efficacy, Safety Between Electric Stimulation-guided Epidural Catheter Placement and the Loss of Resistance Conventional Method for Cesarean Section
Actual Study Start Date : March 11, 2015
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Experimental: Epidural electrical stimulation (EES)
n=20
Device: Epidural electrical stimulation (EES)
Using loss of resistance technique and electrical stimulation

Active Comparator: Loss of resistance (LOR)
n=20
Device: Loss of resistance (LOR)
Using loss of resistance technique only




Primary Outcome Measures :
  1. Success rate of epidural anesthesia [ Time Frame: Up to 6 months ]
    Evaluation parameter : Accuracy comparison between loss of resistance and epidural electrical stimulation


Secondary Outcome Measures :
  1. Maternal satisfaction [ Time Frame: Up to 6 months ]
    Patient satisfaction will be evaluated by a postpartum interview. Satisfaction was graded by patients from 1 to 5, where 1 represented very unsatisfied and 5 represented very satisfied

  2. Neonatal Apgar score [ Time Frame: Up to 6 months ]
    The neonatal apgar scores from 0 to 10 were measured at 1 and 5 minutes to assess the effect of electrical stimulation on the fetus; Scores 7 and above are generally normal, 4 to 6 fairly low, and 3 and below are generally regarded as critically low

  3. Procedure-related complications [ Time Frame: Up to 6 months ]
    The number of times dural puncture or intravascular insertion was performed by Tuohy needle of epidural catheter during epidural anesthesia

  4. Minimum electrical current to elicit a response in the epidural electrical stimulation group [ Time Frame: Up to 6 months ]
    Minimum current stimulus to confirm that the epidural catheter is located in the epidural space between 0 and 5mA ;mA (frequency, 1 Hz; pulse width, 300 ms)

  5. Additional time for epidural electrical stimulation [ Time Frame: Up to 6 months ]
    • Determined by the difference (in seconds) from loss of resistance(LOR) to identification of the epidural space through electrical stimulation
    • Measure : seconds (from observation of LOR to confirmation of the epidural space by electric stimulation)



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Maternal
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who were at 36 to 41 weeks' gestation and admitted in labor to the university clinic for cesarean section were included. Patients were American Society of Anesthesiologists (ASA) physical status of I or II, and were scheduled to receive epidural anesthesia.

Exclusion Criteria:

  • Skin infection at the injection site
  • Difficult catheter placement owing to previous lumbar spinal surgery or deformity
  • Presence of a hemostatic disorder or use of antiplatelet therapy
  • Presence of a cardiac pacemaker.
  • Removal of patient

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443466


Contacts
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Contact: Chung Hun Lee, MD 82-2-2626-3240 bodlch@naver.com
Contact: Sang Sik Choi, MD, PhD 82-2-2626-3238 clonidine@empal.com

Locations
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Korea, Republic of
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of, 08308
Contact: Seung-hoe Song, MBE    82-2-2626-1635    ssessong@korea.ac.kr   
Contact: Ji-young Lee    82-2-2626-2279    ljy@kumc.or.kr   
Principal Investigator: Sang Sik Choi, MD, Ph.D.         
Sub-Investigator: Mi Kyung Lee, MD, Ph.D.         
Sub-Investigator: Chung Hun Lee, MD         
Sub-Investigator: Jung Eun Kim, MD         
Sub-Investigator: Sang Hun Park, MD         
Sponsors and Collaborators
Korea University Guro Hospital
Sewoon Medical Co., Ltd
Investigators
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Principal Investigator: Sang Sik Choi, MD, PhD Korea University Guro Hiospital

Publications:
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Responsible Party: Sang Sik Choi, Professor, Korea University Guro Hospital
ClinicalTrials.gov Identifier: NCT03443466     History of Changes
Other Study ID Numbers: 2015GR0703 (RegionalStimⓇ)
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Sang Sik Choi, Korea University Guro Hospital:
Electric stimulation
Cesarean section