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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06156709
Other study ID # B.30.2.ATA.0.01.00/829
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 20, 2023
Est. completion date October 1, 2025

Study information

Verified date October 2023
Source Ataturk University
Contact Aysenur Dostbil
Phone +905333677796
Email adostbil@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

It is aimed in this study to compare the effect of using local anaesthetics in a higher volume and lower dose on the total anesthetic consumption and quality of labor analgesia with dural puncture epidural technique.


Description:

This study will be conducted as a prospective randomized, controlled, double-blind trial following the approval of the ethical committee at Atatürk University Medical Faculty Hospital and after obtaining written consent from the participating patients. The study will include pregnant women aged 20 to 45 with American Society of Anesthesiologists (ASA) II classification, full-term, nulliparous and singleton pregnancies. Using a randomisation procedure, the participants will be allocated into two equal groups: Group I and Group II.


Recruitment information / eligibility

Status Recruiting
Enrollment 54
Est. completion date October 1, 2025
Est. primary completion date February 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 45 Years
Eligibility Inclusion Criteria: 1. Healthy nulliparous women 2. American Society of Anaesthesiology Score of II 3. During active labor 4. At weeks 37-42. 5. Singlet vertex presentation 6. Cervical dilation <5 cm at the request of labor analgesia 7. VAS score >40 Exclusion Criteria: 1. Age <20 or >45, 2. Morbid obesity 3. Presence of pregnancy-related comorbidities (e.g: gestational diebetes, gestational hypertension and preeclampsia) 4. History of drug abuse 5. Contrindication for neuraxial blocks 6. Conditions that increase the risk of need for cesarean section (e.g. placenta previa, uterus abnormalities or surgeries) 7. Diagnosed fetal abnormalities 8. Cases where dura gets punctured unintendedly with the epiduralneedle 9. Cases where flow of cerebrospinal fluid (CSF) is not observed after dural puncture 10. Cases where a cesarean section is performed at any stage of labor 11. Cases where labor is completed in 1 hour from the start of analgesia procedure.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Group I: Lower Volume with Higher Anaesthetic Concentration
10 ml of a solution containing 0,1% of bupivacaine and 2 mcg/ml fentanyl through the epidural cathether, maintained by programmed intermittant epidural (PIE) boluses of 7,5 ml of the same solution once in every hour, starting 1 hour after the loading dose. patient controlled epidural analgesia (PCEA) will be programmed so that 8 ml of the same solution with a lock-time of 10 ml may be administered
Group II: Higher Volume with LowerAnaesthetic Concentration
20 ml of a solution containing 0,0625% of bupivacaine and 2 mcg/ml fentanyl through the epidural cathether, maintained by programmed intermittant epidural boluses of 15 ml of the same solution once in every hour, starting 1 hour after the loading dose. patient controlled epidural analgesia (PCEA) will be programmed so that 8 ml of the same solution with a lock-time of 10 ml may be administered

Locations

Country Name City State
Turkey Atatürk University Erzurum

Sponsors (1)

Lead Sponsor Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Kaddoum R, Motlani F, Kaddoum RN, Srirajakalidindi A, Gupta D, Soskin V. Accidental dural puncture, postdural puncture headache, intrathecal catheters, and epidural blood patch: revisiting the old nemesis. J Anesth. 2014 Aug;28(4):628-30. doi: 10.1007/s00540-013-1761-y. Epub 2013 Dec 18. — View Citation

Suzuki N, Koganemaru M, Onizuka S, Takasaki M. Dural puncture with a 26-gauge spinal needle affects spread of epidural anesthesia. Anesth Analg. 1996 May;82(5):1040-2. doi: 10.1097/00000539-199605000-00028. — View Citation

Thomas JA, Pan PH, Harris LC, Owen MD, D'Angelo R. Dural puncture with a 27-gauge Whitacre needle as part of a combined spinal-epidural technique does not improve labor epidural catheter function. Anesthesiology. 2005 Nov;103(5):1046-51. doi: 10.1097/00000542-200511000-00019. — View Citation

Wilson SH, Wolf BJ, Bingham K, Scotland QS, Fox JM, Woltz EM, Hebbar L. Labor Analgesia Onset With Dural Puncture Epidural Versus Traditional Epidural Using a 26-Gauge Whitacre Needle and 0.125% Bupivacaine Bolus: A Randomized Clinical Trial. Anesth Analg. 2018 Feb;126(2):545-551. doi: 10.1213/ANE.0000000000002129. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Difference between total local anaesthetic consumption The study will involve monitoring the patients starting 2 minutes after the initial epidural dose, every 2 minutes during the first 20 minutes. Monitoring will continue at the 30th minute, and once in every 90 minutes for 5 hours or until labor is completed.
Total bupivacain consumption will be calculated as follows: PIEB + PCEA + boluses by the clinician. Bupivacain consumption per hour will be calculated.
5 hours or before if the labor is completed
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