Clinical trial NCT06156709: Effect of Higher Volume and Lower Dose on Analgesic Quality During Labor Analgesia With Dural Puncture Epidural
Official title: The Effect of Using Local Anesthetics in a Higher Volume and Lower Dose On Analgesic Quality of Labor Analgesia With Dural Puncture Epidural Technique: Double-Blind Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Analgesia
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2023-12-05
Enrollment: 54
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Difference between total local anaesthetic consumption
timeFrame: 5 hours or before if the labor is completed
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Atatürk University
Study officials:
affiliation: Ataturk University
name: Ayşenur Dostbil
role: STUDY_DIRECTOR
References:
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.
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.
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.
citation: 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.