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Clinical Investigation of Hydromorphone and Sufentanil in Postoperative Patient-Controlled Intravenous Analgesia (PCIA) Following Orthopedic Surgery

Clinical Investigation of Hydromorphone and Sufentanil in Postoperative Patient-Controlled Intravenous Analgesia (PCIA) Following Orthopedic Surgery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096123
Enrollment
Unknown
Registered
2025-01-17
Start date
2025-02-01
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

Postoperative analgesia in orthopedics

Interventions

Sufentanil group :Sufentanil 100 µg + Palonosetron 0.5 mg + 0.9% normal saline to 100 ml
Hydromorphone group :Hydromorphone 8 mg + Palonosetron 0.5 mg + 0.9% normal saline to 100 ml

Sponsors

Huzhou Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Patients scheduled for elective orthopaedic surgery under general anaesthesia and undergoing postoperative PCIA; (2) ASA class I-II; (3) Age 18-65 years and gender; (4) BMI in the range of 18.5-29 kg/m^2.

Exclusion criteria

Exclusion criteria: (1) Combined with serious diseases of heart, brain, liver, kidney and haematopoietic system; (2) Degree II or higher atrioventricular block, bradycardia (HR<50 beats/min), and hypotension (SBP<90mmHg); (3) History of neurological disease; history of chronic pain; history of alcohol abuse; (4) Patients with abuse of analgesic or sedative medications, or a known history of opioid allergy; (5) Those with neurological, psychiatric, or speech impairments that preclude pain assessment; (6) Those with poor compliance and unable to co-operate with the procedure; (7) Those who have participated in a clinical trial of another drug within 3 months; (8) Other patients whom the investigator considers unsuitable for enrolment;

Design outcomes

Primary

MeasureTime frame
Pain score of VAS activity ;

Secondary

MeasureTime frame
VAS resting pain score ;The total number of PCAs;The effective times of PCA;The occurrence times of remedial analgesic medication;Rescue analgesic dose;The consumption of PCA in the patient's analgesic pump;Evaluation of patients' satisfaction with analgesia;The incidence rates of drowsiness or difficulty in awakening, skin itching, vertigo, nausea and vomiting, respiratory depression and other adverse reactions;

Countries

China

Contacts

Public ContactZhang Qin

Huzhou Central Hospital

18895339778@163.com+86 188 9533 9778

Outcome results

None listed

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