Epidural AnalgesiaNCT03161717
Efficacy and Safety of Electrical Stimulation-guided Epidural Analgesia for Vaginal Delivery
A study testing Epidural electrical stimulation (EES) and Loss of resistance (LOR) in people with Epidural Analgesia, run by Sang Sik Choi at 1 site in South Korea.
Trial 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 electrical stimulation group (n=20). Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Epidural Analgesia
- What is being tested?
- Epidural electrical stimulation (EES) and Loss of resistance (LOR)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Mar 2015to Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Korea University Guro Hospital
Seoul, 08308
Seung-hoe Song, MBE, 82-2-2626-1635, ssessong@korea.ac.kr
Da-in Lee, 82-2-2626-2279, 0124dain@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Epidural Analgesia
- Being tested
- Epidural electrical stimulation (EES), Loss of resistance (LOR)
- Keywords
- electrical stimulation, vaginal delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural electrical stimulation (EES)Device
Using loss of resistance technique and electrical stimulation
Loss of resistance (LOR)Device
Using loss of resistance technique only
| Study group | Role | What they receive |
|---|---|---|
| Epidural electrical stimulation (EES) | Experimental | n=20 Receives: Device: Epidural electrical stimulation (EES) |
| Loss of resistance (LOR) | Active comparator | n=20 Receives: Device: Loss of resistance (LOR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of epidural analgesia
Evaluation parameter : Accuracy comparison between loss of resistance and epidural electrical stimulation
Measured: Up to 6 months
Secondary outcomes (5)
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
Measured: Up to 6 months
Neonatal Apgar score
Assessment of neonatal
Measured: Up to 6 months
Procedure-related complications
- Check allergy reaction of anesthetics or chlorohexidine
- Check whether Insert of local anesthetics to intravascular or not
Measured: 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
Measured: 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
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start11 Mar 2015
- Primary completionMar 2019 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Epidural AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sang Sik Choi
- Sponsor type
- University, hospital or other
- Collaborators
- Sewoon Medical Co., Ltd
- Responsible party
- Sponsor-investigator, Sang Sik Choi, Korea University Guro Hospital
- Investigators
- Sang Sik Choi, MD, PhD, Principal investigator, Korea University Guro Hiospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03161717
- Sponsor's protocol ID
- MD14043 (RegionalStimⓡ)
- Status last verified
- May 2017
- First submitted
- 18 May 2017
- Last updated
- 22 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 23144567Wantman 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.
PubMed 16548958Eappen 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.
PubMed 15321183Hermanides 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.
PubMed 22735301Tsui 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.
PubMed 10443599Tsui 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.
PubMed 9717595
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03161717
- Acronym / sponsor ID
- MD14043 (RegionalStimⓡ)
- Conditions
- Epidural Analgesia
- Keywords
- electrical stimulation, vaginal delivery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sang Sik ChoiUniversity, hospital or other
- Collaborators
- Sewoon Medical Co., Ltd
- Study start
- 11 Mar 2015 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 22 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Epidural electrical stimulation (EES) | Experimental | Device: Epidural electrical stimulation (EES)n=20 |
| Loss of resistance (LOR) | Active comparator | Device: Loss of resistance (LOR)n=20 |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural electrical stimulation (EES)Using loss of resistance technique and electrical stimulation | Device | Epidural electrical stimulation (EES) |
| Loss of resistance (LOR)Using loss of resistance technique only | Device | Loss of resistance (LOR) |
Primary outcome
Success rate of epidural analgesia
Time frame: Up to 6 months
Evaluation parameter : Accuracy comparison between loss of resistance and epidural electrical stimulation
5 secondary outcomes
Maternal satisfaction
Time frame: Up to 6 months
Neonatal Apgar score
Time frame: Up to 6 months
Procedure-related complications
Time frame: Up to 6 months
Minimum electrical current to elicit a response in the epidural electrical stimulation group
Time frame: Up to 6 months
Additional time for epidural electrical stimulation
Time frame: Up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2017.
- Background: PubMed 23144567Silva 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.
- Background: PubMed 16548958Wantman 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.
- Background: PubMed 15321183Eappen 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.
- Background: PubMed 22735301Hermanides 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.
- Background: PubMed 10443599Tsui 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.
- Background: PubMed 9717595Tsui 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang Sik Choi, MD, PhD principal investigator
Korea University Guro Hiospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural electrical stimulation (EES) and Loss of resistance (LOR) in people with Epidural Analgesia, run by Sang Sik Choi at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chung Hun Lee, MD (82-2-2626-3240, bodlch@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of epidural analgesia (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03161717, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2017.