Epidural Analgesia Clinical Trial
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | March 2019 |
Est. primary completion date | March 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 19 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Korea University Guro Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Sang Sik Choi | Sewoon Medical Co., Ltd |
Korea, Republic of,
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. — View Citation
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. Review. — View Citation
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. — View Citation
Tsui BC, Gupta S, Finucane B. Confirmation of epidural catheter placement using nerve stimulation. Can J Anaesth. 1998 Jul;45(7):640-4. — View Citation
Tsui BC, Tarkkila P, Gupta S, Kearney R. Confirmation of caudal needle placement using nerve stimulation. Anesthesiology. 1999 Aug;91(2):374-8. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Success rate of epidural analgesia | Evaluation parameter : Accuracy comparison between loss of resistance and epidural electrical stimulation | Up to 6 months | |
Secondary | 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 | |
Secondary | Neonatal Apgar score | Assessment of neonatal | Up to 6 months | |
Secondary | Procedure-related complications | Check allergy reaction of anesthetics or chlorohexidine Check whether Insert of local anesthetics to intravascular or not |
Up to 6 months | |
Secondary | 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 | |
Secondary | 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 |
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