An interventional study of consumption of local anesthetic measurement in Delivery, sponsored by University Hospital, Caen. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-23.
Sponsored by University Hospital, Caen · Not applicable, Interventional, and Treatment
Epidural analgesia is a significant feature of the everyday experience of the delivery room. Its benefits on the maternal experience and in terms of security has been widely demonstrated.
However, some women under epidural analgesia have experienced motor block, which has been found to contribute in the lengthening of the duration of labor, dystocia and instrumental delivery. Therefore, in recent years, reducing these side effects by modifying local anesthetics, concentration of local anesthetic and injected volume has been a priority, with one aim: optimize analgesia without motor blockage.
Although epidural analgesia was first provided by continuous epidural infusion, the efficacy of intermittent epidural bolus has been demonstrated. Small regularly spaced intermittent boluses lead to a more extensive and symmetrical spread of local anesthetic in the epidural space. These findings have led to a new kind of administration combining epidural intermittent boluses with patient-controlled boluses called PEIB (Patient Epidural Intermittent Bolus). On clinical grounds, PEIB is associated with reduced local anesthetic consumption and higher maternal satisfaction.
While PEIB is experimentally and clinically approved, incidence of maternal motor block and instrumental vaginal delivery don't decrease significantly with this programming. We hypothesized that automatic intermittent boluses can lead to an accumulation of local anesthetic overlapping with patient bolus. This accumulation can be the source of motor block, dystocia and instrumental delivery. Therefore, we propose to lead a monocentric prospective randomized study upon 308 patients in order to compare PEIB to epidural analgesia totally controlled by the patient. We expect a lower consumption of local anesthetic and a lower incidence of motor block, dystocia and instrumental delivery with the free automatic bolus programming.
Local anesthetic used: levobupivacaine 0,625mg/ml
Solution prepared with 200 ml of levobupivacaine 0,625mg/ml associated with analgesic adjuvants: sufentanyl 50 micrograms and clonidine 75 micrograms.
Randomization between:
or
Supervision and care consistent with french expert conference of the SFAR (Société Française d'Anesthésie-Réanimation) on management of women under epidural analgesia.
Exclusion Criteria:
* automatic hourly bolus: 8ml (5mg) on 3 min * patient controlled bolus: 8ml (5mg) on 3 min * refractory period: 8min * continuous infusion: 0 * maximum dose: 65mg/4h
Other: consumption of local anesthetic measurement
Epidural analgesia totally controlled by the patient * automatic hourly bolus: 0 * patient controlled bolus: 8ml (5mg) on 3 min * refractory period: 8min * continuous infusion: 0 * maximum dose: 65mg/4h
Other: consumption of local anesthetic measurement
consumption of local anesthetic measurement in both groups
consumption of local anesthetic
Time frame: during delivery
Incidence of motor block
Time frame: during delivery
Incidence of dystocia
Time frame: during delivery
Incidence of instrumental delivery
Time frame: during delivery
Incidence of caesarian
Time frame: during delivery
Incidence of oxytocin administration
Time frame: during delivery
the evaluation of pain by a numerical scale rated from 0 to 10
Time frame: during delivery
Patient satisfaction with Likert type scale from A: excellent to E: catastrophic for the overall experience
Time frame: during delivery
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Caen