Emotional pain and epidural analgesia - a randomised, controlled trial comparing the effect of two commonly used epidural combinations on psychological as well as physical well-being

ISRCTN	ISRCTN46607354
DOI	https://doi.org/10.1186/ISRCTN46607354
Protocol serial number	N0211102717
Sponsor	Department of Health (UK)
Funder	Royal Surrey County Hospital NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Mr John Stones
Scientific

Royal Surrey County Hospital
Egerton Road
Guildford
GU2 7XX
United Kingdom

Phone	+44 (0)1483 571122 Ext 4453

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To establish the preparation for post-operative pain relief that works best.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Signs and Symptoms: Pain
Intervention	Group 1: Fentanyl Group 2: Diamorphine
Intervention type	Other
Primary outcome measure(s)	1. Mood state profile and psychological well-being 2. Analgesia 3. Sedation 4. Respiratory rate 5. Nausea 6. Pruritis 7. Patient satisfaction
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2003

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Key inclusion criteria	Adults receiving postoperative epidural anaesthesia
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/11/2001
Date of final enrolment	31/12/2003

Royal Surrey County Hospital

Guildford
GU2 7XX
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan