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

Phase 1

• Conditions: Analgesia; MedDRA version: 9.1Level: LLTClassification code 10002182Term: Analgesia

• Registration Number: EUCTR2009-011458-16-GB
• Lead Sponsor: orth Wales NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-06-05
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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