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Clinical Trials/CTRI/2021/04/033031
CTRI/2021/04/033031
Completed
Phase 4

Effect of labor analgesia using combined spinal epidural technique with programmed intermittent boluses vs. normal vaginal delivery without epidural analgesia on perceived pain and its effects on the symptoms of postpartum depression

Government Medical College and Hospital Chandigarh0 sites62 target enrollmentTBD

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Not specified
Sponsor
Government Medical College and Hospital Chandigarh
Enrollment
62
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
July 31, 2022
Last Updated
3 years ago
Study Type
Interventional

Investigators

Sponsor
Government Medical College and Hospital Chandigarh

Eligibility Criteria

Inclusion Criteria

  • American Society of Anesthesiologists (ASA) grade I and II
  • Age \>18 years
  • Primigravida
  • Single gestation
  • Cephalic presentation at \>\= 37 completed weeks of gestation
  • In early spontaneous labor (cervical dilation \<\= 5 cm)
  • Baseline pain score \> 30 (on a 0\-100 VAS)
  • Able to use PCEA pump
  • Parturient consenting to participate in the study

Exclusion Criteria

  • Refusal by parturient.
  • Obesity (weight \>100kg)
  • Parturient who had received oral or parenteral analgesics in the last 4 hours.
  • Systemic and local sepsis.
  • Deranged coagulation profile.
  • Preterm labor ( \<37th completed week i.e., \<259 days)
  • Obstetric complications (e.g., premature rupture of amniotic membranes, eclampsia, antepartum hemorrhage).
  • Foetus with a non\-re\-assuring non\-stress test
  • Foetus with known or suspected congenital abnormalities
  • Allergy to study drugs, i.e., levobupivacaine, fentanyl

Outcomes

Primary Outcomes

Not specified

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