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Analgesic Efficacy and Safety of Hydromorphone for Patient-Controlled Intravenous Analgesia after Arthroscopic Rotator Cuff Repair of the Shoulder

Analgesic Efficacy and Safety of Hydromorphone for Patient-Controlled Intravenous Analgesia after Arthroscopic Rotator Cuff Repair of the Shoulder

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125958
Enrollment
Unknown
Registered
2026-06-01
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-06-08

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

Conditions

Target diseaseRotator Cuff Injury, Acute Postoperative Pain After Arthroscopic Rotator Cuff Repair of Shoulder

Interventions

Control Group(Sufentanil Group):Sufentanil Intravenous Patient-Controlled Analgesia (PCIA)
Experimental Group(Hydromorphone Group):Hydromorphone Intravenous Patient-Controlled Analgesia (PCIA)

Sponsors

The First Affiliated Hospital of the Baotou Medical College of Inner Mongolia University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Patients diagnosed with rotator cuff injury and scheduled for elective arthroscopic rotator cuff repair, aged 18 to 75 years, with no gender restriction; 2.ASA physical status class ? to ?, with no severe dysfunction of the heart, liver, kidney, lung or other vital organs; 3.Clear consciousness, normal communication ability, and able to cooperate with pain assessment, patient-controlled analgesia pump operation and postoperative rehabilitation training; 4.Patients and their family members have given informed consent, voluntarily participated in this study, and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Patients with hypersensitivity to hydromorphone, opioids, or adjuvant medications used in this study; 2.Patients with a history of opioid abuse or long-term use of analgesics; 3.Patients complicated with coagulation disorders, mental illness or cognitive dysfunction; 4.Patients with severe cardiopulmonary insufficiency or hepatic and renal dysfunction; 5.Pregnant or lactating women; 6.Patients who have participated in other clinical studies within the past 3 months.

Design outcomes

Primary

MeasureTime frame
Blood oxygen saturation, heart rate, mean arterial pressure;Bruggrmann Comfort Scale (BCS) Score;Visual Analogue Scale (VAS) Pain Score at Rest;Ramsay Sedation Scale Score;

Secondary

MeasureTime frame
Intraoperative Sufentanil and Remifentanil Dosage;Demographic Baseline Characteristics at Enrollment (Age, Gender, Height, Weight, BMI, etc.);Time to First Ambulation and Time to First Flatus Postoperatively;Postoperative Hospital Length of Stay;Postoperative Hospital Anxiety and Depression Scale (HAD) Score;Postoperative Quality of Recovery-15 (QoR-15) Score;Total PCIA Presses and Effective PCIA Presses;Time to First Rescue Analgesia and Number of Rescue Analgesic Episodes within 48 Hours Postoperatively;Incidence of Adverse Reactions (Nausea and Vomiting, Dizziness and Drowsiness, Pruritus, Hallucinations and Delirium, Respiratory Depression with SpO?<90%);

Countries

China

Contacts

Public ContactQi Fengling

The First Affiliated Hospital of the Baotou Medical College of Inner Mongolia University of Science and Technology

18648600458@163.com+86 472 2178609

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026