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

Not Applicable

• Conditions: Pain, Labor; Labor Pain; Epidural
• Interventions: Procedure: Programmed intermittent bolus epidural; Procedure: Provider administered analgesia on patient request

• Registration Number: NCT05034211
• Lead Sponsor: Aretaieio Hospital

Brief Summary

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.

Detailed 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

Study Timeline

• Study First Submitted: 2021-06-15
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-28
• Last Update Submitted: 2021-08-28
• Study First Posted: 2021-09-05
• Last Update Posted: 2021-09-05
• Study Start: 2021-10-01
• Primary Completion: 2022-03-01
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Programmed intermittent Bolus Epidural technique	Programmed intermittent bolus epidural	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
Provider administered bolus epidural technique on patient request	Provider administered analgesia on patient request	10ml ropivacaine 0,2% and 1,5 mcg/ml fentanyl, will be administered by the provider on patient request

Primary Outcome Measures

Name	Time	Method
Total local anesthetic and opioid administration	24hours	the total mg of local anesthetic and opioid consumed via the epidural catheter until the neonate delivery

Secondary Outcome Measures

Name	Time	Method
time needed for delivery	24hours	how long will it take for the baby to be delivered(in minutes)
apgar score	24hours	a test given to newborns soon after birth. This test checks a baby's heart rate, muscle tone, and other signs to see if extra medical care or emergency care is needed. The test is usually given twice: once at 1 minute after birth, and again at 5 minutes after birth.The higher the score the better the baby's condition willl be (the scale is from 0 to 10)
type of delivery	24hours	whether it will be vaginal delivery, vaginal assisted delivery with instruments or a cesarean section
Bromage score	24hours	This scale assesses the intensity of motor block by the patient's ability to move their lower extremities. O signifies free movement and 4 complete paralysis(higher score means worse outcome)
Pain score(NRS scale)	24hours	n a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10 . O represents no pain and 10 the worst pain ever possible
total patient satisfaction	24hours	from a scale of 0 to 10, higher score signifies better outcome
neonatal arterial blood gases	24hours	when the baby will be delivered, a neonatal arterial blood gas will be measured
time for sucessful level of analgesia	24hours	the time needed after epidural bolus to reach a scale below 3 on the NRS scale for pain assesment

Trial Locations

Locations (1)

Aretaieio Hospital; 🇬🇷 Athens, Attiki, Greece