Efficacy and Safety of Electrical Stimulation-guided Epidural Analgesia for Vaginal Delivery

A Comparative Study of Success Rate, Efficacy, Safety Between Electrical Stimulation-guided Epidural Catheter Placement and the Loss of Resistance Conventional Method for Vaginal Delivery

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 electrical stimulation group (n=20). Pain will be assessed using a numerical visual analog scale and maternal satisfaction by a post-partum interview. The success rate of epidural analgesia, maternal satisfaction, and neonatal Apgar scores will be compared between groups.

Study Overview

• Status: Unknown
• Conditions: Epidural Analgesia
• 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 electrical stimulation.

Epidural catheter placement, electrical 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 Loss of resistance (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 Tuohy needle.

The same process will be followed for the Epidural electrical stimulation (EES) group. In addition, the epidural space will be confirmed by epidural electrical 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 delivery room. To control labor pain, a one-time injection containing 50 mcg of fentanyl, 3 mL of 0.75% ropivacaine, and 6 mL of normal saline (total volume 10 mL) will be administered. A continuous infusion of 3 to 10 mL/hour depending on the patient's pain will be used of 75 mcg of fentanyl, 8.5 mL of 0.75% ropivacaine, and 40 mL of normal saline (total volume 50 mL).

Blood pressure (BP), heart rate (HR), oxygen saturation (SpO2), and neurologic assessment findings will be monitored up to 72 hours after labor.

Pain relief in labor is assessed by a change 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 before epidural anesthesia and after epidural anesthesia. Differences in the VAS response 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 analgesia is defined by sensory block, without motor block, and a decrease in pain score after adequate dosing of epidural medication. Failure of epidural analgesia is defined by a lack of sensory block and a less that 2 point difference on the VAS after adequate dosing of epidural medications.

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 electrical stimulation on the neonate. Additional time required for epidural electrical stimulation will be determined by the difference (in seconds) from LOR to identification of the epidural space through electrical 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: Da-in Lee; Phone Number: 82-2-2626-2279; Email: 0124dain@gmail.com
    • Principal Investigator: Sang Sik Choi, MD, PhD
    • Sub-Investigator: Chung Hun Lee, MD
    • Sub-Investigator: Mi Kyoung Lee, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older 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 vaginal delivery were included. Patients were American Society of Anesthesiologists (ASA) physical status of I or II, and were scheduled to receive epidural analgesia

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
• Injection of an analgesic within the previous 12 hours
• Presence of a cardiac pacemaker

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 analgesia	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 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	Up to 6 months
Neonatal Apgar score	Assessment of neonatal	Up to 6 months
Procedure-related complications	Check allergy reaction of anesthetics or chlorohexidine; Check whether Insert of local anesthetics to intravascular or not	Up to 6 months
Minimum electrical current to elicit a response in the epidural electrical stimulation group	Check stimulation strength that patients begin the feel for the first; Check the proper stimulation part of body	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	Up to 6 months

Collaborators and Investigators

• Sponsor: Sang Sik Choi
• 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.

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: May 18, 2017
• First Submitted That Met QC Criteria: May 18, 2017
• First Posted (Actual): May 22, 2017

Study Record Updates

• Last Update Posted (Actual): May 22, 2017
• Last Update Submitted That Met QC Criteria: May 18, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: electrical stimulation; vaginal delivery
• Other Study ID Numbers: MD14043 (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