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Different Routes of Dexamethasone Administration During Epidural Labor Analgesia and Risk of Clinically Significant Postpartum Low Back Pain: A Randomized, Double-Blind, Controlled Trial

Clinical Study on the Prevention of Postpartum Low Back Pain Using Combined Labor Analgesia and Dexamethasone Administration

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111286
Enrollment
Unknown
Registered
2025-10-29
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum low back pain

Interventions

Group A:Epidural injection of dexamethasone 5 mg (2 mL)
Group B:Local infiltration of 5 mg (2 mL) dexamethasone into the subcutaneous and deep tissues surrounding the puncture site.
Group C:Local infiltration of dexamethasone 2.5 mg (1 mL) at the puncture site + Epidural injection of dexamethasone 2.5 mg (1 mL)
Group D:Inject an equal volume of physiological saline (2 mL) into the corresponding pathway.

Sponsors

Maternity and Child Health Care Hospital in Guangxi Zhuang Autonomous Region
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Pregnant women aged 18–45 years. 2. Singleton pregnancy with cephalic presentation, gestational age >=37 weeks and <=42 weeks (term pregnancy). 3. Planned vaginal delivery with intended use of epidural (or intrathecal) analgesia for labor. 4. ASA physical status classification II–III. 5. Able to comprehend study content and voluntarily sign written informed consent. 6. Absence of absolute contraindications to epidural/intrathecal anesthesia during delivery (see exclusion criteria), with clinical assessment deeming epidural analgesia appropriate. 7. Expected ability to complete at least 30 days of follow-up (i.e., residing within the study follow-up area or capable of timely in-person/telephone follow-ups, with provision of reliable contact information).

Exclusion criteria

Exclusion criteria: 1. Individuals with a history of chronic low back pain or spinal disorders. 2. Contraindications for spinal puncture: including infection at the puncture site, severe coagulation disorders, or post-spinal surgery modifications. 3. Individuals with impaired glucose metabolism or endocrine disorders. 4. Individuals with allergies or a history of severe adverse reactions to dexamethasone or local anesthetics (e.g., ropivacaine, lidocaine). 5. Concurrent infectious diseases or fever >38°C (including active infections such as respiratory infections, chorioamnionitis). 6. Pregnancy complicated by severe conditions: severe gestational hypertension, preeclampsia/eclampsia, hepatic or renal dysfunction. 7. Multiple gestation, abnormal fetal presentation (breech or transverse), or planned cesarean section. 8. Obese pregnant women with BMI >=35 kg/m². 9. Individuals with mental or cognitive impairments, language communication difficulties, or inability to accurately cooperate with pain assessments or complete follow-up. 10. Participants who refuse or are unable to complete the 30-day follow-up during the study period. 11. Individuals deemed unsuitable for enrollment by the investigator (e.g., those with concomitant conditions affecting low back pain or safety concerns).

Design outcomes

Primary

MeasureTime frame
Incidence of Postpartum Low Back Pain;

Secondary

MeasureTime frame
Postpartum Low Back Pain Score;Postpartum Inflammatory Markers in Mothers;

Countries

China

Contacts

Public ContactWenqing Jiang

Maternity and Child Health Care Hospital in Guangxi Zhuang Autonomous Region

823774267@qq.com+86 158 7819 1049

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026