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

Labor Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05034211
• Other study ID #: 342/25/5/21
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: August 2021
• Source: Aretaieio Hospital
• Contact: Anteia Paraskeva, Dr
• Phone: 306972868078
• Email: aparask[@]med.uoa.gr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 43 Years

Eligibility

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

Related Conditions & MeSH terms

• Epidural
• Labor Pain
• Pain, Labor

Intervention

Procedure:
• Programmed intermittent bolus epidural
one arm will receive programmed intermittent boluses of local anesthetic via the epidural catheter on fixed time intervals. Standard 27G Tuohy needle epidural set with epidural catheter insertion on L2-L3 site, with the patient either sitting or in the lateral decubitus position will be used. Local injection with 6 ml lidocaine 2% will be performed before the insertion of the epidural needle
• Provider administered analgesia on patient request
one arm will receive bolus of local anesthetic via the catheter upon patient request. Standard 27G Tuohy needle epidural set with epidural catheter insertion on L2-L3 site, with the patient either sitting or in the lateral decubitus position will be used. Local injection with 6 ml lidocaine 2% will be performed before the insertion of the epidural needle

Locations

Country	Name	City	State
Greece	Aretaieio Hospital	Athens	Attiki

Sponsors (1)

Lead Sponsor	Collaborator
Aretaieio Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total local anesthetic and opioid administration	the total mg of local anesthetic and opioid consumed via the epidural catheter until the neonate delivery	24hours
Secondary	time needed for delivery	how long will it take for the baby to be delivered(in minutes)	24hours
Secondary	total patient satisfaction	from a scale of 0 to 10, higher score signifies better outcome	24hours
Secondary	apgar score	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)	24hours
Secondary	Bromage score	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)	24hours
Secondary	type of delivery	whether it will be vaginal delivery, vaginal assisted delivery with instruments or a cesarean section	24hours
Secondary	neonatal arterial blood gases	when the baby will be delivered, a neonatal arterial blood gas will be measured	24hours
Secondary	time for sucessful level of analgesia	the time needed after epidural bolus to reach a scale below 3 on the NRS scale for pain assesment	24hours
Secondary	Pain score(NRS scale)	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	24hours