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Comparison of efficacy and side effects of intrathecal fentanyl with intrathecal morphine - Intrathecal opiates

Comparison of efficacy and side effects of intrathecal fentanyl with intrathecal morphine - Intrathecal opiates

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-011458-16-GB
Enrollment
90
Registered
2009-06-05
Start date
2009-09-10
Completion date
Unknown
Last updated
2019-12-10

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

Conditions

Analgesia MedDRA version: 9.1 Level: LLT Classification code 10002182 Term: Analgesia

Interventions

Trade Name: Fentanyl citrate injection Pharmaceutical Form: Solution for injection INN or Proposed INN: FENTANYL CITRATE CAS Number: 990738 Concentration unit: µg/ml microgram(s)/millilitre Concentrat

Sponsors

North Wales NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ASA 1 and 2 Patients undergoing Spinal Anaesthesia for elective hip replacements will be selected. recruited Above patients who have given informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Children < 18 years old. Pregnant women Patients with contraindications to spinal anaesthetic Patients unable to give informed consent. Patient refusal

Design outcomes

Primary

MeasureTime frame
Main Objective: We propose to look at 3 groups of patients to compare the efficacy and side effects profiles of intrathecal fentanyl and intrathecal morphine.;Secondary Objective: Does using 100mcg of morphine as opposed to 50 mcg of morphine increases the side effects or makes a difference to the analgesia?;Primary end point(s): Usage of analgesia in the first 24 hours postoperative

Countries

United Kingdom

Outcome results

None listed

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