Labor AnalgesiaNCT07007650
Effects of Ropivacaine Concentrations on Prolonged Labor Analgesia
A study testing High-concentration Ropivacaine and Low concentration ropivacaine group in people with Labor Analgesia and Prolonged, run by Chengdu Jinjiang Maternity and Child Health Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Labor Analgesia, Prolonged, Ropivacaine
- What is being tested?
- High-concentration Ropivacaine and Low concentration ropivacaine group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 14 Jun 2025to 10 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA II
- Age ≥ 18 years
- Singleton pregnancy
- No contraindications for epidural puncture and voluntarily accepting labor analgesia
- Maternal participants changing the first pump fluid
Who cannot join
- Contraindications for epidural labor analgesia
- Serious heart, brain, liver, or kidney diseases
- Mental abnormalities
- Neurological diseases
- Maternal request for management of breakthrough pain before changing the pump fluid
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Chengdu Jinjiang District Women & Children Health Hospital,
Chengdu, Sichuan, 610011
jianjun mao, BS, +8615008460156, 614928098@qq.com
About this study
Official title: Effects of Different Concentrations of Ropivacaine on Prolonged Labor Analgesia
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.
Read the detailed description
Background:
With changes in medical models and improvements in quality of life, parturients have higher expectations for childbirth, making the alleviation and elimination of labor pain an important aspect of modern obstetrics. Intrathecal labor analgesia is widely used in clinical practice to relieve labor pain. However, studies on prolonged labor analgesia, especially following the replacement of the first analgesic pump, are scarce. Medical institutions often continue to use traditional analgesic formulations without relevant guidelines or expert consensus. Prolonged analgesia may reduce pain tolerance in parturients, possibly necessitating adjustments in local anesthetic concentration to improve analgesic effectiveness. Given the clinical research gap, this study aims to explore the effects of different concentrations of ropivacaine on prolonged labor analgesia and its impact on maternal and neonatal safety.
Objective:
To investigate the effects and maternal-neonatal safety of using different concentrations of ropivacaine for prolonged labor analgesia, providing clinical evidence for optimizing labor analgesia regimens.
Methods:
This single-center prospective randomized controlled study will collect clinical data from parturients receiving labor analgesia at Chengdu Jinjiang District Maternal and Child Health Hospital from May to August 2025. Participants meeting the inclusion and exclusion criteria will be included. Following the replacement of the first analgesic pump, parturients will be randomly assigned to receive one of two ropivacaine concentration regimens (Group H: 0.12% ropivacaine; Group N: 0.1% ropivacaine). Data collection will include demographic information, pain scores, labor-related parameters, neonatal outcomes, and adverse reactions.
Interventions:
- Group H: 0.12% ropivacaine + 0.5µg/ml sufentanil
- Group N: 0.1% ropivacaine + 0.5µg/ml sufentanil Following the replacement of the first analgesic pump, parturients will receive the respective ropivacaine concentration formulation, with pain relief effects and labor-related indicators assessed at specified intervals.
Primary Outcome:
Pain scores at different time points (T0: at pump replacement; T1: 0.5 hours after pump replacement; T2: 1 hour after pump replacement; T3: at full cervical dilation or during transition to cesarean section).
Secondary Outcomes:
- Labor-related indicators: Duration of first, second, and third stages of labor, blood loss, rate of instrumental delivery, mode of delivery (vaginal/cesarean).
- Neonatal indicators: Neonatal weight, Apgar scores at 1 minute, 5 minutes, and 10 minutes.
- Adverse reactions: Hypotension, nausea/vomiting, intrapartum fever (T≥38.0℃).
Hypothesis:
Different concentrations of ropivacaine for prolonged intrathecal labor analgesia will have varying effects on pain control and maternal-neonatal safety, with higher concentration ropivacaine (0.12%) likely being more effective in pain relief, while both concentrations are expected to show no significant difference in maternal and neonatal safety.
Ethics Approval:
This study has received approval from the ethics committee of Chengdu Jinjiang District Maternal and Child Health Hospital (Approval Number: 202312). All participants must sign an informed consent form to ensure the respect of participant rights and data confidentiality. The study will strictly adhere to relevant ethical standards and legal regulations to protect participant safety and privacy.
Funding:
This study is funded by the following projects:
- Chengdu Medical Research Project (No. 2023465)
- Chengdu Medical Research Project (No. 2022548)
- Chengdu Medical Research Project (No. 2023304)
- Conditions
- Labor Analgesia, Prolonged, Ropivacaine, Concentration
- Being tested
- High-concentration Ropivacaine, Low concentration ropivacaine group
- Keywords
- Labor Analgesia, Ropivacaine Concentration, Prolonged Pain, Maternal-Neonatal Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-concentration RopivacaineDrug
After the first pump fluid is depleted, switch to 0.12% ropivacaine to continue labor analgesia.
Low concentration ropivacaine groupDrug
After the first pump fluid is depleted, switch to 0.12% ropivacaine to continue labor analgesia.
| Study group | Role | What they receive |
|---|---|---|
| high concentration ropivacaine group | Experimental | The combination of 0.12% ropivacaine and 0.5 μg/ml sufentanil Receives: Drug: High-concentration Ropivacaine |
| Low concentration ropivacaine group. | Active comparator | The combination of 0.1% ropivacaine and 0.5 μg/ml sufentanil Receives: Drug: Low concentration ropivacaine group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From pump replacement to the end of labor analgesia.
Secondary outcomes (4)
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)
Measured: From pump replacement to the end of labor analgesia.
Mode of delivery
The mode of delivery will be recorded (vaginal birth/cesarean section).
Measured: At the end of delivery
Neonatal Apgar score
The Apgar Score will be recorded for the newborn at 1 minute, 5 minutes, and 10 minutes after delivery.
Measured: 10 minutes after the delivery of the fetus
nausea and vomiting questionnaire
Nausea and vomiting will be recorded if they occur after changing the infusion until the end of delivery.
Measured: From pump replacement to the end of labor analgesia.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start14 Jun 2025 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion10 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Labor AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Jinjiang Maternity and Child Health Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fei Jia, Chengdu Jinjiang Maternity and Child Health Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07007650
- Sponsor's protocol ID
- 202312
- Status last verified
- Jun 2025
- First submitted
- 26 May 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For our study "Effects of Different Concentrations of Ropivacaine on Prolonged Labor Analgesia," we have decided not to share Individual Participant Data (IPD). This decision is due to privacy concerns, data security requirements, ethical approval limitations, legal restrictions, and the study's design which did not accommodate data sharing. We believe this aligns with ethical standards and operational capabilities.
Publications
Jian Z, Longqing R, Dayuan W, Fei J, Bo L, Gang Z, Siying Z, Yan G. Prolonged duration of epidural labour analgesia decreases the success rate of epidural anaesthesia for caesarean section. Ann Med. 2022 Dec;54(1):1112-1117. doi: 10.1080/07853890.2022.2067353.
PubMed 35443838Ni JX, Feng JL, Yao SJ, Ni LF, Song SB, Song CZ, Qian XW, Mei Z, Yu J. Determination of the Dose-Response Relationship of Epidural Dexmedetomidine Combined with Ropivacaine for Labor Analgesia. Drug Des Devel Ther. 2022 Mar 6;16:609-618. doi: 10.2147/DDDT.S346842. eCollection 2022.
PubMed 35281318Tan HS, Reed SE, Mehdiratta JE, Diomede OI, Landreth R, Gatta LA, Weikel D, Habib AS. Quality of Labor Analgesia with Dural Puncture Epidural versus Standard Epidural Technique in Obese Parturients: A Double-blind Randomized Controlled Study. Anesthesiology. 2022 May 1;136(5):678-687. doi: 10.1097/ALN.0000000000004137.
PubMed 35157756Hawkins JL. Epidural analgesia for labor and delivery. N Engl J Med. 2010 Apr 22;362(16):1503-10. doi: 10.1056/NEJMct0909254. No abstract available.
PubMed 20410515
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Concentrations of Ropivacaine on Prolonged Labor Analgesia
- ClinicalTrials.gov ID
- NCT07007650
- Acronym / sponsor ID
- 202312
- Conditions
- Labor Analgesia, Prolonged, Ropivacaine, Concentration
- Keywords
- Labor Analgesia, Ropivacaine Concentration, Prolonged Pain, Maternal-Neonatal Safety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chengdu Jinjiang Maternity and Child Health HospitalUniversity, hospital or other
- Study start
- 14 Jun 2025 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 10 Sep 2025 (estimated)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
With changes in medical models and improvements in quality of life, parturients have higher expectations for childbirth, making the alleviation and elimination of labor pain an important aspect of modern obstetrics. Intrathecal labor analgesia is widely used in clinical practice to relieve labor pain. However, studies on prolonged labor analgesia, especially following the replacement of the first analgesic pump, are scarce. Medical institutions often continue to use traditional analgesic formulations without relevant guidelines or expert consensus. Prolonged analgesia may reduce pain tolerance in parturients, possibly necessitating adjustments in local anesthetic concentration to improve analgesic effectiveness. Given the clinical research gap, this study aims to explore the effects of different concentrations of ropivacaine on prolonged labor analgesia and its impact on maternal and neonatal safety.
Objective:
To investigate the effects and maternal-neonatal safety of using different concentrations of ropivacaine for prolonged labor analgesia, providing clinical evidence for optimizing labor analgesia regimens.
Methods:
This single-center prospective randomized controlled study will collect clinical data from parturients receiving labor analgesia at Chengdu Jinjiang District Maternal and Child Health Hospital from May to August 2025. Participants meeting the inclusion and exclusion criteria will be included. Following the replacement of the first analgesic pump, parturients will be randomly assigned to receive one of two ropivacaine concentration regimens (Group H: 0.12% ropivacaine; Group N: 0.1% ropivacaine). Data collection will include demographic information, pain scores, labor-related parameters, neonatal outcomes, and adverse reactions.
Interventions:
- Group H: 0.12% ropivacaine + 0.5µg/ml sufentanil
- Group N: 0.1% ropivacaine + 0.5µg/ml sufentanil Following the replacement of the first analgesic pump, parturients will receive the respective ropivacaine concentration formulation, with pain relief effects and labor-related indicators assessed at specified intervals.
Primary Outcome:
Pain scores at different time points (T0: at pump replacement; T1: 0.5 hours after pump replacement; T2: 1 hour after pump replacement; T3: at full cervical dilation or during transition to cesarean section).
Secondary Outcomes:
- Labor-related indicators: Duration of first, second, and third stages of labor, blood loss, rate of instrumental delivery, mode of delivery (vaginal/cesarean).
- Neonatal indicators: Neonatal weight, Apgar scores at 1 minute, 5 minutes, and 10 minutes.
- Adverse reactions: Hypotension, nausea/vomiting, intrapartum fever (T≥38.0℃).
Hypothesis:
Different concentrations of ropivacaine for prolonged intrathecal labor analgesia will have varying effects on pain control and maternal-neonatal safety, with higher concentration ropivacaine (0.12%) likely being more effective in pain relief, while both concentrations are expected to show no significant difference in maternal and neonatal safety.
Ethics Approval:
This study has received approval from the ethics committee of Chengdu Jinjiang District Maternal and Child Health Hospital (Approval Number: 202312). All participants must sign an informed consent form to ensure the respect of participant rights and data confidentiality. The study will strictly adhere to relevant ethical standards and legal regulations to protect participant safety and privacy.
Funding:
This study is funded by the following projects:
- Chengdu Medical Research Project (No. 2023465)
- Chengdu Medical Research Project (No. 2022548)
- Chengdu Medical Research Project (No. 2023304)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high concentration ropivacaine group | Experimental | Drug: High-concentration RopivacaineThe combination of 0.12% ropivacaine and 0.5 μg/ml sufentanil |
| Low concentration ropivacaine group. | Active comparator | Drug: Low concentration ropivacaine groupThe combination of 0.1% ropivacaine and 0.5 μg/ml sufentanil |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ASA II
- Age ≥ 18 years
- Singleton pregnancy
- No contraindications for epidural puncture and voluntarily accepting labor analgesia
- Maternal participants changing the first pump fluid
Key exclusion criteria (5 listed)
- Contraindications for epidural labor analgesia
- Serious heart, brain, liver, or kidney diseases
- Mental abnormalities
- Neurological diseases
- Maternal request for management of breakthrough pain before changing the pump fluid
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-concentration RopivacaineAfter the first pump fluid is depleted, switch to 0.12% ropivacaine to continue labor analgesia. | Drug | high concentration ropivacaine group |
| Low concentration ropivacaine groupAfter the first pump fluid is depleted, switch to 0.12% ropivacaine to continue labor analgesia. | Drug | Low concentration ropivacaine group. |
Primary outcome
Visual Analog Scale (VAS) Pain Score
Time frame: From pump replacement to the end of labor analgesia.
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).
4 secondary outcomes
Modified Bromage score
Time frame: From pump replacement to the end of labor analgesia.
Mode of delivery
Time frame: At the end of delivery
Neonatal Apgar score
Time frame: 10 minutes after the delivery of the fetus
nausea and vomiting questionnaire
Time frame: From pump replacement to the end of labor analgesia.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Results publication: PubMed 35443838Jian Z, Longqing R, Dayuan W, Fei J, Bo L, Gang Z, Siying Z, Yan G. Prolonged duration of epidural labour analgesia decreases the success rate of epidural anaesthesia for caesarean section. Ann Med. 2022 Dec;54(1):1112-1117. doi: 10.1080/07853890.2022.2067353.
- Results publication: PubMed 35281318Ni JX, Feng JL, Yao SJ, Ni LF, Song SB, Song CZ, Qian XW, Mei Z, Yu J. Determination of the Dose-Response Relationship of Epidural Dexmedetomidine Combined with Ropivacaine for Labor Analgesia. Drug Des Devel Ther. 2022 Mar 6;16:609-618. doi: 10.2147/DDDT.S346842. eCollection 2022.
- Results publication: PubMed 35157756Tan HS, Reed SE, Mehdiratta JE, Diomede OI, Landreth R, Gatta LA, Weikel D, Habib AS. Quality of Labor Analgesia with Dural Puncture Epidural versus Standard Epidural Technique in Obese Parturients: A Double-blind Randomized Controlled Study. Anesthesiology. 2022 May 1;136(5):678-687. doi: 10.1097/ALN.0000000000004137.
- Results publication: PubMed 20410515Hawkins JL. Epidural analgesia for labor and delivery. N Engl J Med. 2010 Apr 22;362(16):1503-10. doi: 10.1056/NEJMct0909254. No abstract available.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. For our study "Effects of Different Concentrations of Ropivacaine on Prolonged Labor Analgesia," we have decided not to share Individual Participant Data (IPD). This decision is due to privacy concerns, data security requirements, ethical approval limitations, legal restrictions, and the study's design which did not accommodate data sharing. We believe this aligns with ethical standards and operational capabilities.
Related trials for Labor Analgesia
Recruiting
The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in Infants
Newborn Care, Pain Management
Not yet recruiting
The 90% Effective Initial Volume for Labor Analgesia Under Double Dural Puncture Epidural Technique
Labor Pain
Not yet recruiting
Initiation Ropivacaine Dose for Labor Analgesia Via Double Dural Puncture Epidural Technique
Labor Pain
Not yet recruitingObservational study
Effect of Dural Puncture Epidural Analgesia on Oxytocin in Early vs Late Labor
Labor Analgesia, Labor Pain
Not yet recruitingObservational study
Machine Learning to Predict Fever After Labor Analgesia
Intrapartum Fever
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-concentration Ropivacaine and Low concentration ropivacaine group in people with Labor Analgesia and Prolonged, run by Chengdu Jinjiang Maternity and Child Health Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bo Liu, MS (+8618502846036, liubojjfy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) Pain Score (time frame: From pump replacement to the end of labor analgesia.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07007650, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.