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Effect of fixed-dose versus body weight-based intravenous analgesia pumps on analgesic efficacy after urethral repair and reconstruction surgery in non-obese patients: A prospective cohort study (The NOPE Trial)

Effect of fixed-dose versus body weight-based intravenous analgesia pumps on analgesic efficacy after urethral repair and reconstruction surgery in non-obese patients: A prospective cohort study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600118259
Enrollment
Unknown
Registered
2026-02-03
Start date
2026-02-28
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Urethral repair and reconstruction surgery

Interventions

Oliceridine group:None

Sponsors

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Adult male patients undergoing elective urethral repair and reconstruction surgery under general anesthesia

Exclusion criteria

Exclusion criteria: 1. BMI > 30 kg/m^2; 2. Analgesic pump programming strategy accommodates both weight-based and fixed-dose scenarios; 3. Inability to comprehend numerical rating scales for pain assessment; 4. Long-term opioid use or opioid tolerance; 5. Severe impairment of cardiac, pulmonary, hepatic, or renal function.

Design outcomes

Primary

MeasureTime frame
Incidence of moderate to severe pain at rest during the first 72 hours after surgery;

Secondary

MeasureTime frame
Postoperative pain scores at rest and during movement;Time of first postoperative rescue analgesia and number of rescue analgesia episodes;Patient satisfaction scores for postoperative analgesia;Postoperative nausea and vomiting grading;Postoperative respiratory depression and subclinical respiratory depression;Ramsay sedation scale;Athens insomnia scale (AIS) score;The score of the Europe Health-Related Quality of Life Questionnaire 5 Dimensions (EQ-5D);Time of first ambulation after surgery;Safety indicators (including: nausea and vomiting, respiratory depression, hypotension, hypertension, tachycardia, bradycardia, excessive sedation, pruritus, dizziness, constipation, fever, chills, restlessness during the recovery period, dry mouth, abdominal distension, bladder spasm, etc.;

Countries

China

Contacts

Public ContactDong Yushan

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

practitioner_dys@foxmail.com+86 139 5630 9323

Outcome results

None listed

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