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Effect of patient-controlled intravenous analgesia with sufentanil on postpartum pain in vaginal delivery women: a randomized, double-blind, placebo-controlled study

Effect of patient-controlled intravenous analgesia with sufentanil on postpartum pain in vaginal delivery women: a randomized, double-blind, placebo-controlled study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070711
Enrollment
Unknown
Registered
2023-04-20
Start date
2023-04-30
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

Postpartum pain after vaginal delivery

Interventions

Experimental group:Patient controlled-intravenous analgesia with sufentanil
Control group:Patient controlled-intravenous analgesia with normal saline

Sponsors

Affiliated Hospital of Guangdong Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. The puerpera who give birth through vagina are 37 to 42 weeks old; 2 ASA II-III puerpera; 3.The puerpera who agree to participate in this experiment and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. The puerpera with serious complications during delivery, including massive bleeding (bleeding volume =500ml), uterine rupture, amniotic fluid embolism and other obstetricians and anesthesiologists think it is not suitable to participate in this study. 2. The puerpera who turned to cesarean section; 3. The puerpera who have mental disorder and can't cooperate with this study; 4. The puerpera who allergic to sufentanil; 5 The puerpera who participate in another researcher; 6 The puerpera with a history of drug abuse; 7 The puerpera who use chronic antidepressants, anti-anxiety drugs and long-term analgesic drugs; 8 The puerpera with severe renal insufficiency; 9 The puerpera who refused to participate in this research.

Design outcomes

Primary

MeasureTime frame
NRS Pain Score during 24-hour Postpartum Activity (Cough);

Secondary

MeasureTime frame
Total pain NRS score of parturient at other time points after delivery;NRS scores of different pain parts of parturient immediately, 12, 24, 36, 48 hours and one week after delivery.;Ramsay sedation score and vital signs immediately, 12, 24, 36 and 48 hours after delivery.;Time for the first time for lying-in women to go to the fields after delivery;Effect of postpartum pain on daily life activities of parturient women;Sleep time and vital signs of infants at 24 hours and 48 hours after delivery;Time for parturient to start lactation after delivery;Incidence of postpartum complications of lying-in women;Postpartum hospitalization time of parturient;Maternal satisfaction score after delivery;

Countries

China

Contacts

Public ContactJian Mo

Affiliated Hospital of Guangdong Medical University

562201246@qq.com+86 13702731555

Outcome results

None listed

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