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A prospective, randomised, controlled trial for intrathecal hydromorphone combined with ropivacaine for postoperative pain relief in children

A prospective, randomised, controlled trial for intrathecal hydromorphone combined with ropivacaine for postoperative pain relief in children

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032806
Enrollment
Unknown
Registered
2020-05-11
Start date
2020-05-08
Completion date
Unknown
Last updated
2020-05-11

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

Conditions

Operation of lower abdomen, perineum and lower extremity in children

Interventions

Group 1:After anesthesia induction, the sacral block will be performed, and 0.2% ropivacaine will be given 1ml/kg + 0.2% ropivacaine 1ml / kg
Group 2:After anesthesia induction, the sacral block will be performed, and 0.2% ropivacaine will be given 1ml/kg

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 6 Years

Inclusion criteria

Inclusion criteria: 1) children aged 1-6years old; 2) children undergoing elective lower abdominal, perineal and lower extremity surgery; 3) operation time > 30 minutes; 4) patients receiving PCIA after operation; 5) signing informed consent.

Exclusion criteria

Exclusion criteria: 1) Coagulation dysfunction, with contraindications for puncture; 2) sacral canal closure; 3) congenital heart disease; 4) epilepsy; 5) communication or intelligence disorders; 6) obesity; 7) hypersensitivity to known drugs; 8) severe liver and kidney dysfunction, severe genetic and metabolic diseases; 9) patients refused to participate in the study.

Design outcomes

Primary

MeasureTime frame
Pain scores;

Secondary

MeasureTime frame
Time of the first strong painful after operation;Number of the strong painful after operation;Sedation scores;Restlessness score in recovery period;Postoperative PCIA effective compressions;Total 24h consumption of opioids;Parents' satisfaction score on analgesia effect;Sleep status after operation;Rate of adverse events;

Countries

China

Contacts

Public ContactYun xia Zuo

West China Hospital, Sichuan University

zuoyunxiahxa@qq.com+86 18980601541

Outcome results

None listed

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