NCT02963337

Brief Summary

Remifentanil may be an ideal drug for labor analgesia due to its pharmacodynamic and pharmacokinetic profile. As compared to epidural analgesia, it demonstrated satisfactory for pain relief at the beginning of labour with a gradual elevation of pain scores as labour progresses. However, fast onset and limited time efficacy may render it useful in multiparous with a faster labor progression, thus even making it an alternative to single-shot spinal analgesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
162

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

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

November 7, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 15, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

October 16, 2019

Status Verified

October 1, 2019

Enrollment Period

1.7 years

First QC Date

November 7, 2016

Last Update Submit

October 13, 2019

Conditions

Labor PainLabor; Prolonged, Second StageLabor; Prolonged, First Stage

Keywords

remifentanilcombined spinal-epidural analgesiamultiparous

Outcome Measures

Primary Outcomes (1)

  • Pain relief with remifentanil or CSE in multiparous women

    Reduction in visual analog scoring after institution of the respective pain treatments

    two years

Secondary Outcomes (2)

  • Patient satisfaction with pain relief

    two years

  • Duration of first and second stage of labor

    one year

Study Arms (2)

remifentanil PCA

The patients in the remifentanil group will receive remifentanil hydrochloride (Ultiva, GlaxoSmithKline, Oslo, Norway) diluted in physiologic saline to a concentration of 40µg/ml and administered using PCA pump with a bolus duration of 20 sec. A stepwise bolus doses from 15 to 30 µg, maximum 40 per 2 min will be applied with no background infusion.

Drug: remifentanil

Combined spinal-epidural analgesia PCA

A 27-gauge needle will be placed via the shaft of the epidural needle inserted at the L2-3/L3-4 inter-space by the investigator. After confirming the CSF, 2,5 mg of bupivacaine with 20 µg of fentanyl will be injected. That will be followed by the placement of a 20-gauge multi-hole catheter into the epidural space which will be connected to the PCA pump with a possibility of injecting 6-10 ml 0,1% bupivacaine with 2 µg of fentanyl/ml every 20 min with no background infusion.

Drug: combined spinal-epidural analgesia

Interventions

remifentanilDRUG

Remifentanil PCA will be used to deliver intravenous drug boluses from 20 to 40 micrograms per 2 min lockout interval.

Also known as: ULTIVA
remifentanil PCA
combined spinal-epidural analgesiaDRUG

Patient controlled epidural analgesia will be used to deliver epidural boluses of 6-10 ml of 0,1% bupivacaine with 2 micrograms of fentanyl per ml per 15 min lockout interval.

Also known as: bupivacaine epidurally
Combined spinal-epidural analgesia PCA

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Multiparous

You may qualify if:

  • patients' request for pain relief
  • ASA physical status 1-3
  • uncomplicated singleton pregnancy with cefalic presentation
  • gestation age \> 37 weeks
  • regular uterine contractions
  • cervical dilation 2-5 cm
  • anticipated vaginal delivery
  • fetus without suspected abnormality and normal CTG

You may not qualify if:

  • contraindications for remifentanil usage
  • contraindications for CSE

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Ljubljana, Ljubljana, Slovenia

Ljubljana, 1000, Slovenia

Location

Related Publications (2)

  • Douma MR, Middeldorp JM, Verwey RA, Dahan A, Stienstra R. A randomised comparison of intravenous remifentanil patient-controlled analgesia with epidural ropivacaine/sufentanil during labour. Int J Obstet Anesth. 2011 Apr;20(2):118-23. doi: 10.1016/j.ijoa.2010.11.009. Epub 2011 Mar 3.

    PMID: 21376564RESULT

  • Blajic I, Zagar T, Semrl N, Umek N, Lucovnik M, Stopar Pintaric T. Analgesic efficacy of remifentanil patient-controlled analgesia versus combined spinal-epidural technique in multiparous women during labour. Ginekol Pol. 2021;92(11):797-803. doi: 10.5603/GP.a2021.0053. Epub 2021 Apr 29.

    PMID: 33914329DERIVED

MeSH Terms

Conditions

Labor Pain

Interventions

Remifentanil

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Vesna Novak Jankovic, Professor

    University Medical Centre

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, MD, PhD

Study Record Dates

First Submitted

November 7, 2016

First Posted

November 15, 2016

Study Start

January 1, 2017

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

October 16, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)