NCT05034211

Brief Summary

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.

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 5, 2021

Completed
26 days until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

September 5, 2021

Status Verified

August 1, 2021

Enrollment Period

5 months

First QC Date

June 15, 2021

Last Update Submit

August 28, 2021

Conditions

Labor PainEpiduralPain, Labor

Keywords

dural punctureprogrammed intermittent boluslabor analgesia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • time needed for delivery

    24hours

  • total patient satisfaction

    24hours

  • apgar score

    24hours

  • Bromage score

    24hours

  • type of delivery

    24hours

  • +3 more secondary outcomes

Study Arms (2)

Programmed intermittent Bolus Epidural technique

ACTIVE COMPARATOR

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

Provider administered bolus epidural technique on patient request

ACTIVE COMPARATOR

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

Interventions

Programmed intermittent bolus epiduralPROCEDURE

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

Programmed intermittent Bolus Epidural technique
Provider administered analgesia on patient requestPROCEDURE

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

Provider administered bolus epidural technique on patient request

Eligibility Criteria

Age20 Years - 43 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • nulliparous women
  • th week of gestation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aretaieio Hospital

Athens, Attica, 11528, Greece

RECRUITING

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Anteia Paraskeva, Dr

CONTACT

306972868078aparask@med.uoa.gr

Polyxeni Theodosopoulou, MD

CONTACT

xeniathd@gmail.com

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
Resident anesthesiologist

Study Record Dates

First Submitted

June 15, 2021

First Posted

September 5, 2021

Study Start

October 1, 2021

Primary Completion

March 1, 2022

Study Completion

June 1, 2022

Last Updated

September 5, 2021

Record last verified: 2021-08

Locations

GR(1)