NCT06156709

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2023

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 26, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 5, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

December 5, 2023

Status Verified

October 1, 2023

Enrollment Period

1.2 years

First QC Date

November 26, 2023

Last Update Submit

November 26, 2023

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Group I

ACTIVE COMPARATOR

The patients will be given 10 ml of a solution containing 0,1% of bupivacaine and 2 mcg/ml fentanyl through the epidural cathether. Level of sensory block will be tested by testing with ice from S2 dermatome cephally. Analgesia will be 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. In addition, 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. "Breakthrough pain" that requires even further analgesia will be treated with an epidural bolus of 5 ml of 0,125% bupivacain solution.

Procedure: Group I: Lower Volume with Higher Anaesthetic Concentration

Group II

ACTIVE COMPARATOR

The patients will be given 20 ml of a solution containing 0,0625% of bupivacaine and 2 mcg/ml fentanyl through the epidural cathether. Analgesia will be maintained by programmed intermittant epidural boluses of 15 ml of the same solution once in every hour, starting 1 hour after the loading dose. In addition, 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. "Breakthrough pain" that requires even further analgesia will be treated with an epidural bolus of 5 ml of 0,125% bupivacain solution.

Procedure: Group II: Higher Volume with LowerAnaesthetic Concentration

Interventions

Group I: Lower Volume with Higher Anaesthetic ConcentrationPROCEDURE

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 I
Group II: Higher Volume with LowerAnaesthetic ConcentrationPROCEDURE

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

Group II

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy nulliparous women
  • American Society of Anaesthesiology Score of II
  • During active labor
  • At weeks 37-42.
  • Singlet vertex presentation
  • Cervical dilation \<5 cm at the request of labor analgesia
  • VAS score \>40

You may not qualify if:

  • Age \<20 or \>45,
  • Morbid obesity
  • Presence of pregnancy-related comorbidities (e.g: gestational diebetes, gestational hypertension and preeclampsia)
  • History of drug abuse
  • Contrindication for neuraxial blocks
  • Conditions that increase the risk of need for cesarean section (e.g. placenta previa, uterus abnormalities or surgeries)
  • Diagnosed fetal abnormalities
  • Cases where dura gets punctured unintendedly with the epiduralneedle
  • Cases where flow of cerebrospinal fluid (CSF) is not observed after dural puncture
  • Cases where a cesarean section is performed at any stage of labor
  • Cases where labor is completed in 1 hour from the start of analgesia procedure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atatürk University

Erzurum, Turkey (Türkiye)

RECRUITING

Related Publications (4)

  • 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.

    PMID: 8610864BACKGROUND

  • 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.

    PMID: 16249679BACKGROUND

  • 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.

    PMID: 28622178BACKGROUND

  • 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.

    PMID: 24347033BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ayşenur Dostbil

    Ataturk University

    STUDY DIRECTOR

Central Study Contacts

Ayşenur Dostbil

CONTACT

+905333677796adostbil@hotmail.com

Ayşenur Dostbil

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

November 26, 2023

First Posted

December 5, 2023

Study Start

November 20, 2023

Primary Completion

February 1, 2025

Study Completion

October 1, 2025

Last Updated

December 5, 2023

Record last verified: 2023-10

Locations

TU(1)