Effects of Ropivacaine Concentrations on Prolonged Labor Analgesia

NCT07007650 | Not Yet Recruiting

• 1 other identifier: 202312
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Labor Analgesia; Prolonged; Ropivacaine; Concentration

Keywords

Labor Analgesia; Ropivacaine Concentration; Prolonged Pain; Maternal-Neonatal Safety

Outcome Measures

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).

  From pump replacement to the end of labor analgesia.

Secondary Outcomes (4)

• Modified Bromage score

  From pump replacement to the end of labor analgesia.

• Mode of delivery

  At the end of delivery

• Neonatal Apgar score

  10 minutes after the delivery of the fetus

• nausea and vomiting questionnaire

  From pump replacement to the end of labor analgesia.

Study Arms (2)

high concentration ropivacaine group

EXPERIMENTAL

The combination of 0.12% ropivacaine and 0.5 μg/ml sufentanil

Drug: High-concentration Ropivacaine

Low concentration ropivacaine group.

ACTIVE COMPARATOR

The combination of 0.1% ropivacaine and 0.5 μg/ml sufentanil

Drug: Low concentration ropivacaine group

Interventions

High-concentration Ropivacaine DRUG

After the first pump fluid is depleted, switch to 0.12% ropivacaine to continue labor analgesia.

high concentration ropivacaine group

Low concentration ropivacaine group DRUG

After the first pump fluid is depleted, switch to 0.12% ropivacaine to continue labor analgesia.

Low concentration ropivacaine group.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study is open to women who are planning a vaginal delivery and voluntarily accepting labor analgesia.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA II
• Age ≥ 18 years
• Singleton pregnancy
• No contraindications for epidural puncture and voluntarily accepting labor analgesia
• Maternal participants changing the first pump fluid

You may not qualify if:

• 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

Sponsors & Collaborators

• Chengdu Jinjiang Maternity and Child Health Hospital: lead

Study Sites (1)

Chengdu Jinjiang District Women & Children Health Hospital,

Chengdu, Sichuan, 610011, China

Location

Related Publications (4)

• 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.

  PMID: 35443838 RESULT

• Ni 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.

  PMID: 35281318 RESULT

• Tan 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.

  PMID: 35157756 RESULT

• Hawkins 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.

  PMID: 20410515 RESULT

Related Links

• Related Info

Central Study Contacts

Bo Liu, MS

CONTACT

+8618502846036; liubojjfy@163.com

Fei Jia, MD

CONTACT

+8618581877655; jiafei1980@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A double-blind design is a research method aimed at eliminating bias between participants and researchers. In this design, participants are randomly assigned to different intervention groups (such as different concentrations of ropivacaine), and neither the participants nor the researchers responsible for evaluating the results are aware of the specific group allocations. This ensures the objectivity and reliability of the research findings, avoiding the influence of subjective expectations or observational biases on data interpretation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Anesthesiology Department

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 6, 2025
• Study Start: June 14, 2025
• Primary Completion: August 1, 2025
• Study Completion: September 10, 2025
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)