Universiy hospital
Limoges, 87000, France
NCT Number: NCT02563821
Background : Recently, delivery of local anaesthetics via Programmed Intermittent Epidural Bolus (PIEB) has been shown to improve labour epidural analgesia compared to delivery via Continuous Epidural Infusion (CEI).
Purpose : However, the superiority of PIEB compared to CEI has not been investigated for third trimester voluntary termination of pregnancy.
We hypothesized that PIEB administration would result in a better degree of satisfaction of the patients compared with CEI for third trimester legally induced abortion analgesia.
Looking for future studies?
Notify Me18 year and older
Female
Interventional
Phase 3
Limoges, 87000, France
Abstract : The recent technical advances in antenatal diagnosis have led to an increase number of legally induced abortion at the third trimester of pregnancy. Psychological pain is frequently associated to physical pain in these kinds of interventions. So anaesthetists are more and more involved in voluntary termination of pregnancy analgesia.
In France, Patient Controlled Epidural Analgesia (PCEA) with CEI mode is usually used for voluntary termination of pregnancy analgesia. But recent studies have shown that PIEB mode as compared to CEI mode increases maternal satisfaction during labour. This may be attributed to a more extensive spread of epidural solution when delivered as a bolus rather than continuous infusion.
Few trials have been interested in investigating the best mode of PCEA for legally induced abortion analgesia.
This study includes women who undergo voluntary third semester termination of pregnancy. Patients are randomized to PIEB or CEI for pain analgesia. In this randomized, double-blind study, the investigators assess the degree of satisfaction of the patients (primary outcome), the incidence of motor block, total drug consumption and adverse events (secondary outcomes) between the two study groups.
The different values are collected during the intervention on a specific paper for each patient and the degree of satisfaction is reported on this paper just before the patient leaves the birth room (approximatively 2 hours after the expulsion).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: procedure
The degree of satisfaction is assessed using a satisfaction visual analog scale (SVAS) where 0 corresponded to " completely unsatisfied " and 100 to " completely satisfied ".
Time frame: procedure
Incidence of motor block determined by number and intensity
Time frame: procedure
Number of call of the aneshetist for insufficient analgesia
Time frame: procedure
Number of doses of complementary manual bolus administered
Time frame: procedure
time of the intervention, doses of oxytocin and prostin used, instrumental delivery
Time frame: procedure
Numbers of Adverse events (Pruritus, nausea / vomitings, episodes of arterial low blood pressure)
University Hospital, Limoges
Other
Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Third Trimester Medical Termination of Pregnancy Analgesia : a Randomized Study.
Acronym: PCEA-IMG
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05906368
Anesthesia, Epidural, Cardiovascular Diseases
Pittsburgh, Pennsylvania, United States
View Trial DetailsNCT05642234
Agnosia, Analgesia, Epidural
Istanbul, Fatih, Turkey (Türkiye)
View Trial DetailsNCT01260051
Anesthesia, Epidural, Behavior
Cleveland, Ohio, United States
View Trial DetailsNCT04240912
Anesthesia, Epidural
Rome, Italy
View Trial Details