A Comparison Between 2 Methods of Local Anesthetic Administration for Maintaining Labor Analgesia After Dural Puncture Epidural

Intermittent epidural bolus technique opens a new era of interest for maintaining labor anlagesia. The study examines programmed intermittent epidural bolus technique on a scheduled basis to provider-administered bolus anlgesia on patient request, after a dural puncture epidural technique.

Study Overview

• Status: Recruiting
• Conditions: Labor Pain; Pain, Labor; Epidural
• Intervention / Treatment: Procedure: Programmed intermittent bolus epidural; Procedure: Provider administered analgesia on patient request

Detailed Description

After dural puncture, an epidural catheter will be placed on nulliparous women between 38 and 40 weeks of gestation presenting for labor . All will receive an test dose of 3ml lidocaine 2%, for properly checking the catheter placement and then an initial dose of 10ml ropivacaine 0,2% with 2 mcg/ml fentanyl. After that, women will be randomly assigned on two groups. Both groups will be receiving the same dose of analgesia (10ml ropivacaine 0,2% plus 1,5 mcg/ml fentanyl. However, one group will be receiving them on scheduled time intervals as programmed intermittent boluses every 60minutes and the other only on patient request for pain relief.

Pain scores, satisfaction, time for adequate analgesia, bromage scores,apgar scores, fetal arterial blood gases, time for delivery and type of delivery will be studied

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anteia Paraskeva, Dr; Phone Number: 306972868078; Email: aparask@med.uoa.gr
• Study Contact Backup: Name: Polyxeni Theodosopoulou, MD; Email: xeniathd@gmail.com

Study Locations

• Greece
  • Attiki
    • Athens, Attiki, Greece, 11528
      • Recruiting
      • Aretaieio Hospital
      • Contact: Polyxeni Theodosopoulou, MD; Email: xeniathd@gmail.com
      • Contact: Anteia Paraskeva, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

-nulliparous women

• 38th week of gestation

Exclusion Criteria:

• patient refusal to have an epidural
• patient refusal to participate
• contraindication for epidural
• ASA>3
• neurologic deficit/impairment
• allergy on local anesthetic chronic pain syndromes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Programmed intermittent Bolus Epidural technique; 10ml ropivacaine 0,2% and 1,5 mcg/ml fentanyl, will be administered every 60 minutes via an epidural catheter placed for labor analgesia on L2-L3/L3-L4 level	Procedure: Programmed intermittent bolus epidural; one arm will receive programmed intermittent boluses of local anesthetic via the epidural catheter on fixed time intervals. Standard 27G Tuohy needle epidural set with epidural catheter insertion on L2-L3 site, with the patient either sitting or in the lateral decubitus position will be used. Local injection with 6 ml lidocaine 2% will be performed before the insertion of the epidural needle
Active Comparator: Provider administered bolus epidural technique on patient request; 10ml ropivacaine 0,2% and 1,5 mcg/ml fentanyl, will be administered by the provider on patient request	Procedure: Provider administered analgesia on patient request; one arm will receive bolus of local anesthetic via the catheter upon patient request. Standard 27G Tuohy needle epidural set with epidural catheter insertion on L2-L3 site, with the patient either sitting or in the lateral decubitus position will be used. Local injection with 6 ml lidocaine 2% will be performed before the insertion of the epidural needle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total local anesthetic and opioid administration	the total mg of local anesthetic and opioid consumed via the epidural catheter until the neonate delivery	24hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time needed for delivery	how long will it take for the baby to be delivered(in minutes)	24hours
total patient satisfaction	from a scale of 0 to 10, higher score signifies better outcome	24hours
apgar score	a test given to newborns soon after birth. This test checks a baby's heart rate, muscle tone, and other signs to see if extra medical care or emergency care is needed. The test is usually given twice: once at 1 minute after birth, and again at 5 minutes after birth.The higher the score the better the baby's condition willl be (the scale is from 0 to 10)	24hours
Bromage score	This scale assesses the intensity of motor block by the patient's ability to move their lower extremities. O signifies free movement and 4 complete paralysis(higher score means worse outcome)	24hours
type of delivery	whether it will be vaginal delivery, vaginal assisted delivery with instruments or a cesarean section	24hours
neonatal arterial blood gases	when the baby will be delivered, a neonatal arterial blood gas will be measured	24hours
time for sucessful level of analgesia	the time needed after epidural bolus to reach a scale below 3 on the NRS scale for pain assesment	24hours
Pain score(NRS scale)	n a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10 . O represents no pain and 10 the worst pain ever possible	24hours

Collaborators and Investigators

• Sponsor: Aretaieio Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2021
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: June 15, 2021
• First Submitted That Met QC Criteria: August 28, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Actual): September 5, 2021
• Last Update Submitted That Met QC Criteria: August 28, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: labor analgesia; dural puncture; programmed intermittent bolus
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain
• Other Study ID Numbers: 342/25/5/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No