Effects of Ropivacaine Concentrations on Prolonged Labor Analgesia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorChengdu Jinjiang Maternity and Child Health Hospital
About this trial
With the changes in medical models and improvements in people's quality of life, parturients have higher demands for childbirth, making the alleviation and elimination of labor pain an important aspect of modern obstetrics. Intrathecal labor analgesia has been widely adopted in clinical practice to relieve pain. However, current studies mainly focus on parturients who are just beginning to receive labor analgesia, while for those experiencing prolonged analgesia, medical institutions still use traditional formulations, lacking relevant guidelines or expert consensus. In such cases, prolonged waiting and anxiety may lower the pain tolerance of parturients, leading to an increased need for higher concentrations of local anesthetics. To address this clinical gap, this study aims to explore the effects of different concentrations of ropivacaine in prolonged labor analgesia and has designed a prospective randomized controlled trial (RCT) to provide evidence for improving the analgesic regimen for this group of parturients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
ASA II
Age ≥ 18 years
Singleton pregnancy
No contraindications for epidural puncture and voluntarily accepting labor analgesia
Disqualifiers
Contraindications for epidural labor analgesia
Serious heart, brain, liver, or kidney diseases
Mental abnormalities
Neurological diseases
Trial design
Design model
Parallel
Treatments tested in this trial
High-concentration Ropivacaine
DrugAfter the first pump fluid is depleted, switch to 0.12% ropivacaine to continue labor analgesia.
Low concentration ropivacaine group
DrugAfter the first pump fluid is depleted, switch to 0.12% ropivacaine to continue labor analgesia.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: high concentration ropivacaine groupExperimental treatment 1 intervention
Group B: Low concentration ropivacaine group.Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Visual Analog Scale (VAS) Pain Score
The pain will be assessed using the Visual Analog Scale (VAS) at four time points: T0 (at the time of pump fluid change) T1 (0.5 hours after the pump fluid change) T2 (1 hour after the pump fluid change) T3 (when full cervical dilation is achieved/in case of emergency cesarean section).
Time frame
From pump replacement to the end of labor analgesia.Secondary outcomes
1
Modified Bromage score
The level of motor blockade will be assessed using the Modified Bromage Score at four time points: T0 (at the time of pump fluid replacement) T1 (0.5 hours after the pump fluid replacement) T2 (1 hour after the pump fluid replacement) T3 (at full cervical dilation/in case of emergency cesarean section)
Time frame
From pump replacement to the end of labor analgesia.2
Mode of delivery
The mode of delivery will be recorded (vaginal birth/cesarean section).
Time frame
At the end of delivery3
Neonatal Apgar score
The Apgar Score will be recorded for the newborn at 1 minute, 5 minutes, and 10 minutes after delivery.
Time frame
10 minutes after the delivery of the fetus4
nausea and vomiting questionnaire
Nausea and vomiting will be recorded if they occur after changing the infusion until the end of delivery.
Time frame
From pump replacement to the end of labor analgesia.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: