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

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

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.

Study Overview

• Status: Unknown
• Conditions: Epidural Anesthesia
• Intervention / Treatment: Device: Epidural electrical stimulation (EES); Device: Loss of resistance (LOR)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 08308
    • Recruiting
    • Korea University Guro Hospital
    • Contact: Seung-hoe Song, MBE; Phone Number: 82-2-2626-1635; Email: ssessong@korea.ac.kr
    • Contact: Ji-young Lee; Phone Number: 82-2-2626-2279; Email: ljy@kumc.or.kr
    • Sub-Investigator: Chung Hun Lee, MD
    • Principal Investigator: Sang Sik Choi, MD, Ph.D.
    • Sub-Investigator: Mi Kyung Lee, MD, Ph.D.
    • Sub-Investigator: Jung Eun Kim, MD
    • Sub-Investigator: Sang Hun Park, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate of epidural anesthesia	Evaluation parameter : Accuracy comparison between loss of resistance and epidural electrical stimulation	Up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal satisfaction	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	Up to 6 months
Neonatal Apgar score	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	Up to 6 months
Procedure-related complications	The number of times dural puncture or intravascular insertion was performed by Tuohy needle of epidural catheter during epidural anesthesia	Up to 6 months
Minimum electrical current to elicit a response in the epidural electrical stimulation group	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)	Up to 6 months
Additional time for epidural electrical stimulation	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)	Up to 6 months

Collaborators and Investigators

• Sponsor: Korea University Guro Hospital
• Collaborators: Sewoon Medical Co., Ltd
• Investigators: Principal Investigator: Sang Sik Choi, MD, PhD, Korea University Guro Hiospital

Publications and helpful links

General Publications

• Silva M, Halpern SH. Epidural analgesia for labor: Current techniques. Local Reg Anesth. 2010;3:143-53. doi: 10.2147/LRA.S10237. Epub 2010 Dec 8.
• Wantman A, Hancox N, Howell PR. Techniques for identifying the epidural space: a survey of practice amongst anaesthetists in the UK. Anaesthesia. 2006 Apr;61(4):370-5. doi: 10.1111/j.1365-2044.2006.04534.x.
• Eappen S, Blinn A, Segal S. Incidence of epidural catheter replacement in parturients: a retrospective chart review. Int J Obstet Anesth. 1998 Oct;7(4):220-5. doi: 10.1016/s0959-289x(98)80042-3.
• Hermanides J, Hollmann MW, Stevens MF, Lirk P. Failed epidural: causes and management. Br J Anaesth. 2012 Aug;109(2):144-54. doi: 10.1093/bja/aes214. Epub 2012 Jun 26.
• Tsui BC, Tarkkila P, Gupta S, Kearney R. Confirmation of caudal needle placement using nerve stimulation. Anesthesiology. 1999 Aug;91(2):374-8. doi: 10.1097/00000542-199908000-00010.
• Tsui BC, Gupta S, Finucane B. Confirmation of epidural catheter placement using nerve stimulation. Can J Anaesth. 1998 Jul;45(7):640-4. doi: 10.1007/BF03012093.
• Kim YS, Kim HS, Jeong H, Lee CH, Lee MK, Choi SS. Efficacy of electrical stimulation on epidural anesthesia for cesarean section: a randomized controlled trial. BMC Anesthesiol. 2020 Jun 10;20(1):146. doi: 10.1186/s12871-020-01063-1.

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2015
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: January 30, 2018
• First Submitted That Met QC Criteria: February 21, 2018
• First Posted (Actual): February 23, 2018

Study Record Updates

• Last Update Posted (Actual): February 23, 2018
• Last Update Submitted That Met QC Criteria: February 21, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Cesarean section; Electric stimulation
• Other Study ID Numbers: 2015GR0703 (RegionalStimⓇ)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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