An open randomised comparison of the clinical effectiveness and costs of protocol driven opioid analgesia, celiac plexus block, or thoracoscopic splanchnicectomy for pain relief in patients with abdominal malignancy

ISRCTN	ISRCTN91628176
DOI	https://doi.org/10.1186/ISRCTN91628176
Secondary identifying numbers	HTA 97/09/53

Submission date: 25/04/2003
Registration date: 25/04/2003
Last edited: 19/10/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-study-looking-at-pain-relief-for-people-with-advanced-abdominal-cancer

Contact information

Dr Colin Johnson
Scientific

General Surgery
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom

Phone	+44 (0)23 8079 4307
Email	c.d.johnson@soton.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	An open randomised comparison of the clinical effectiveness and costs of protocol driven opioid analgesia, celiac plexus block, or thoracoscopic splanchnicectomy for pain relief in patients with abdominal malignancy
Study acronym	NaTTS
Study objectives	Thoracoscopic splanhnicectomy (TS) or percutaneous celiac plexus block (CPB) may reduce the need for opioids, and their side effects, and may improve quality of life in patients with painful upper GI cancer. This study aims: 1. To show better early pain relief when protocol driven opioid analgesia is supplemented with TS or CPB. This will be determined as the percentage of patients who obtain good pain relief 1 & 2 weeks after study entry (primary end point). 2. To determine the effect at 1, 2 weeks and monthly intervals until death of these interventions on opioid consumption, opioid side effects, and health related quality of life. 3. To compare survival time in the three groups of patients. 4. To evaluate total health care costs (to the hospital, community services and patient) between study entry and death in the three groups and to determine as appropriate the cost-utility, cost effectiveness or mean cost per patient of TS or CPB. From this to form an evidence based judgement of the cost-effectiveness of wider application of this new technology.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Gastrointestinal cancer
Intervention	Protocol-driven opioid analgesia, celiac plexus block, or thoracoscopic splanchnicectomy for pain relief in patients with abdominal malignancy.
Intervention type	Other
Primary outcome measure	To show better early pain relief when protocol driven opioid analgesia is supplemented with TS or CPB. This will be determined as the percentage of patients who obtain good pain relief 1 & 2 weeks after study entry (primary end point).
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/02/2002
Completion date	31/10/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	330
Key inclusion criteria	Patients with gastrointestinal cancer
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/02/2002
Date of final enrolment	31/10/2005

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Southampton General Hospital

Southampton
SO16 6YD
United Kingdom

Sponsor information

University of Southampton (UK)
University/education

University Road
Southampton
SO17 1BJ
England
United Kingdom

Website	http://www.soton.ac.uk/
"ROR"	https://ror.org/01ryk1543

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results				No	Yes
Results article	results	01/10/2009		Yes	No

Editorial Notes

19/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
On 04/09/2009 the overall trial start and end dates were changed from 01/02/2001 and 31/01/2004 to 01/02/2002 and 31/10/2005, respectively.