Conventional patient controlled epidural analgesia (PCEA) versus programmed intermittent epidural boluses (PIEB) for labor analgesia: a randomized, double blind study in nulliparous women

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-004600-30-BE

Enrollment

130

Registered

2015-11-19

Start date

2016-01-18

Completion date

Unknown

Last updated

2021-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

providing adequate analgesia during labor and child birth

Interventions

Trade Name: naropin Product Name: Naropin Pharmaceutical Form: Injection INN or Proposed INN: ROPIVACAINE CAS Number: 84057-95-4 Concentration unit: % percent Concentration type: equal Concentration n

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Nulliparous, term, singleton pregnancies with spontaneous or induced labor Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 130 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - ASA 3, 4 and 5 - Cervical dilatation >7cm - Inability to perform evaluation - Age <18 years - Intolerance to any of the drugs used in the study - Coagulopathy or infection - Clinical evidence of peripheral neuropathies - Refusal to sign informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: Comparison of two techniques to maintain labor analgesia: Programmed intermittent epidural boluses (PIEB) with patient controlled epidural analgesia (PCEA) and the conventional technique, PCEA;Timepoint(s) of evaluation of this end point: every 15 min during the first hour, then once per hour ;Secondary Objective: - Motor blockade: modified Bromage score - Pain scores: VAS score - Motor power evaluated by a straight leg raise test and by a knee bend test - Patient satisfaction: VAS score - Local anesthetic consumption - PCEA boluses (received and requested) - Length of labor - Mode of delivery - Fetal and neonatal outcome (Apgar scores, umbilical artery blood gas, neonatal weight) ;Primary end point(s): Breakthrough pain defined as a VAS score of 30 or more for which the parturient requests additional analgesia and in which the PCEA is insufficient (at least one PCEA bolus has to be administered). Based on previous studies we expect that 25 % of women will experience breakthrough pain requiring additional analgesia by manual boluses.	—

Measure

Time frame

Main Objective: Comparison of two techniques to maintain labor analgesia: Programmed intermittent epidural boluses (PIEB) with patient controlled epidural analgesia (PCEA) and the conventional technique, PCEA;Timepoint(s) of evaluation of this end point: every 15 min during the first hour, then once per hour ;Secondary Objective: - Motor blockade: modified Bromage score - Pain scores: VAS score - Motor power evaluated by a straight leg raise test and by a knee bend test - Patient satisfaction: VAS score - Local anesthetic consumption - PCEA boluses (received and requested) - Length of labor - Mode of delivery - Fetal and neonatal outcome (Apgar scores, umbilical artery blood gas, neonatal weight) ;Primary end point(s): Breakthrough pain defined as a VAS score of 30 or more for which the parturient requests additional analgesia and in which the PCEA is insufficient (at least one PCEA bolus has to be administered). Based on previous studies we expect that 25 % of women will experience breakthrough pain requiring additional analgesia by manual boluses.

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 1 hour and 24 hours after delivery;Secondary end point(s): - Motor blockade: modified Bromage score every hour - Pain -scores: VAS score every hour Motor power evaluated by a straight leg raise test and by a knee bend test (every hour) - Patient satisfaction: VAS score (1 hour and 24 hours after delivery). - Local anesthetic consumption - PCEA boluses (received and requested) - Length of labor - Mode of delivery - Fetal and neonatal outcome (Apgar scores, umbilical artery blood gas, neonatal weight)	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: 1 hour and 24 hours after delivery;Secondary end point(s): - Motor blockade: modified Bromage score every hour - Pain -scores: VAS score every hour Motor power evaluated by a straight leg raise test and by a knee bend test (every hour) - Patient satisfaction: VAS score (1 hour and 24 hours after delivery). - Local anesthetic consumption - PCEA boluses (received and requested) - Length of labor - Mode of delivery - Fetal and neonatal outcome (Apgar scores, umbilical artery blood gas, neonatal weight)

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Countries

Belgium

Contacts

Public Contactresearch anesthesiology

University Hospitals leuven

christel.huygens@uzleuven.be+3216344270

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026