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 |
| Protocol serial number | HTA 97/09/53 |
| Sponsor | University of Southampton (UK) |
| Funder | NIHR Health Technology Assessment Programme - HTA (UK) |
- 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
Contact information
Dr Colin Johnson
Scientific
Scientific
General Surgery
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
| Phone | +44 (0)23 8079 4307 |
|---|---|
| c.d.johnson@soton.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
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). |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/10/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Southampton General Hospital
Southampton
SO16 6YD
United Kingdom
SO16 6YD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2009 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | No | Yes |
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.
