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 designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleAn 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 acronymNaTTS
Study objectivesThoracoscopic 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) studiedGastrointestinal cancer
InterventionProtocol-driven opioid analgesia, celiac plexus block, or thoracoscopic splanchnicectomy for pain relief in patients with abdominal malignancy.
Intervention typeOther
Primary outcome measureTo 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 measuresNot provided at time of registration
Overall study start date01/02/2002
Completion date31/10/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants330
Key inclusion criteriaPatients with gastrointestinal cancer
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/02/2002
Date of final enrolment31/10/2005

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 logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.