A Comparison Between 2 Methods of Local Anesthetic Administration for Maintaining Labor Analgesia After Dural Puncture Epidural

Aretaieio Hospital

Status: Unknown

Conditions: Labor Pain; Pain, Labor; Epidural

Treatments: Procedure: Provider administered analgesia on patient request; Procedure: Programmed intermittent bolus epidural

Study type: Interventional

Funder types: Other

Identifiers

NCT05034211

342/25/5/21

Details and patient eligibility

About

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.

Full description

After dural puncture, an epidural catheter will be placed on nulliparous women between 38 and 40 weeks of gestation presenting for labor . All will receive an test dose of 3ml lidocaine 2%, for properly checking the catheter placement and then an initial dose of 10ml ropivacaine 0,2% with 2 mcg/ml fentanyl. After that, women will be randomly assigned on two groups. Both groups will be receiving the same dose of analgesia (10ml ropivacaine 0,2% plus 1,5 mcg/ml fentanyl. However, one group will be receiving them on scheduled time intervals as programmed intermittent boluses every 60minutes and the other only on patient request for pain relief.

Pain scores, satisfaction, time for adequate analgesia, bromage scores,apgar scores, fetal arterial blood gases, time for delivery and type of delivery will be studied

Enrollment: 100 estimated patients

Sex: Female

Ages: 20 to 43 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

-nulliparous women

• 38th week of gestation

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

Programmed intermittent Bolus Epidural technique

Active Comparator group

Description:

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

Treatment:

Procedure: Programmed intermittent bolus epidural

Provider administered bolus epidural technique on patient request

Active Comparator group

Description:

10ml ropivacaine 0,2% and 1,5 mcg/ml fentanyl, will be administered by the provider on patient request

Treatment:

Procedure: Provider administered analgesia on patient request