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Efficacy and safety of intravenous acetaminophen for postoperative morphine-assisted analgesia: a two-stage multicenter, randomized, double-blind, placebo-controlled parallel clinical trial (Stage II)

Efficacy and safety of intravenous acetaminophen for postoperative morphine-assisted analgesia: a two-stage multicenter, randomized, double-blind, placebo-controlled parallel clinical trial (Stage II)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054865
Enrollment
Unknown
Registered
2021-12-28
Start date
2017-06-01
Completion date
Unknown
Last updated
2022-12-12

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

Conditions

orthopedic surgery

Interventions

Intravenous acetaminophen group:500 mg intravenous acetaminophen every 6 h for 24 h
Placebo group:the same volume of saline every 6 h for 24 h

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 70 years; 2. were scheduled for major orthopedic surgery under general anesthesia during the enrollment period; 3. had an American Society of Anesthesiologists physical status of I or II; 4. had a body mass index of 18-30 kg/m2; and (e) were able to understand the pain scales and operate an intravenous patient-controlled analgesia (PCA) device.

Exclusion criteria

Exclusion criteria: 1. Contraindications to the study medications; 2. uncontrolled hypertension or diabetes; 3. known history of pulmonary or heart disease; 4. impaired liver function, defined as alanine aminotransferase and/or aspartate aminotransferase more than twice the upper limit of normal, or total bilirubin at least 1.5 times the upper limit of normal; 5. renal dysfunction, defined as creatinine levels > 176 µmol/L in serum; 6. pregnant or 7. at high risk of bleeding.

Design outcomes

Primary

MeasureTime frame
morphine consumption within 24 h after surgery;

Secondary

MeasureTime frame
pain intensity at rest and during movement at 1, 3, 6, 12, and 24 h postoperatively;the area under the pain intensity-time curve for pain at rest and during movement;how many times the patient pressed the button on the PCA device during the first 24 h postoperatively, and how many times the button-pushing resulted in effective analgesia;

Countries

China

Contacts

Public ContactFei Liu

West China Hospital, Sichuan University

30333870@qq.com+86 18980605856

Outcome results

None listed

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