Analgesia Effects of Nalbuphine vs Sulfentanil
1 other identifier
interventional
80
0 countries
N/A
Brief Summary
Cesarean section may result in great trauma and postoperative pain. Besides incision pain, uterine contraction pain is another source of postoperative pain after cesarean section. In clinical practice, a large amount of uterine contraction agent is routinely applied after cesarean section so as to promote involution of uterus and reduce postoperative hemorrhage, which also causes great uterine contraction pain. Acute pain is the risk factor of chronic pain, and may postpone the recovery from labour and influence the quality of life of parturient. Though various analgesia modules have been attempted, more than 20% parturients still experience severe postoperative pain, and pain management after cesarean section remains a challenge to anesthesiologists. This study aim to compare the effects of nalbuphine hydrochloride vs sufentanil citrate on patient-controlled intravenous analgesia after cesarean section.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2016
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2015
CompletedFirst Posted
Study publicly available on registry
November 13, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedNovember 13, 2015
October 1, 2015
1 year
October 26, 2015
November 11, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Pain scores of nalbuphine group
up to 24 months
Pain scores of sufentanil group
up to 24 months
Secondary Outcomes (2)
Usage of nalbuphine of nalbuphine group
up to 24 months
Usage of sufentanil of sufentanil group
up to 24 months
Study Arms (2)
Nalbuphine
EXPERIMENTALNalbuphine group: nalbuphine 100 mg, ramosetron 0.3mg, background dose 1ml/h,patient-controlled analgesia(PCA) 1ml/time, lockout time 10 min, flurbiprofen axetil 50mg 6h after operation.
Sufentanil
EXPERIMENTALSufentanil group: sufentanil 100ug, ramosetron 0.3mg, background dose 1ml/h, PCA 1ml/time, lockout time 10 min, flurbiprofen axetil 50mg 6h after operation.
Interventions
patient-controlled intravenous analgesia
patient-controlled intravenous analgesia
Eligibility Criteria
You may qualify if:
- For primipara with selective cesarean section
You may not qualify if:
- Severe preeclampsia,
- pregnancy complicated with diabetes mellitus
- pregnancy complicated with cardiac disease,
- gestation age\<37W
- recently use of opiate drugs or nonsteroidal antiinflammatory drugs within 48 h before operation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Shaoqiang Huang
Department of Anesthesiology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 26, 2015
First Posted
November 13, 2015
Study Start
January 1, 2016
Primary Completion
January 1, 2017
Study Completion
January 1, 2018
Last Updated
November 13, 2015
Record last verified: 2015-10