Study on initial pain management in patients with acute pancreatitis
ISRCTN | ISRCTN10634411 |
---|---|
DOI | https://doi.org/10.1186/ISRCTN10634411 |
- Submission date
- 27/04/2023
- Registration date
- 11/05/2023
- Last edited
- 11/05/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English Summary
Background and study aims
Abdominal pain is the main symptom for most patients with acute pancreatitis (AP). It's important for diagnosing AP and can affect the patient's prognosis. Early management of AP involves pain relief and fluids, but there is debate on the best pain relief protocol. Pain is a big part of the patient's experience and relieving it can improve their quality of life and lower the risk of complications.
Previous studies have not shown a clear favourite among analgesic drugs for AP. A new review of 12 randomized control trials found that epidural analgesia was most effective for pain relief in the first 24 hours, but opioids were just as effective at 48 hours. Non-steroidal anti-inflammatory drugs (NSAIDs) were just as effective as opioids for pain relief in the first 24 hours. However, the studies had limitations and were not able to determine the specific efficacy of each analgesic drug.
Opioids are still the main treatment for pain in AP, but they have side effects like constipation and slow digestion. Recent studies have shown that opioids can worsen AP. Despite the importance of pain relief in AP, there have been few well-designed studies on analgesic protocols, and guidelines for managing AP do not offer clear recommendations.
This study aims to document current analgesic practices for AP in the UK and examine the relationship between analgesics and complications of AP.
Who can participate?
Adults over 18 years, at the first visit to a hospital for acute pancreatitis.
What does the study involve?
This is an observational study looking at patient records, no additional activity is being carried out with participants.
What are the possible benefits and risks of participating?
None
Where is the study run from?
Freeman Hospital (UK)
When is the study starting and how long is it expected to run for?
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Sanjay Pandanaboyana, s.pandanaboyana@nhs.net
Contact information
Principal Investigator
Level 5
Freeman hospital
Newcastle Upon Tyne
Newcastle upon tyne
NE2 2AW
United Kingdom
0000-0003-3099-2197 | |
Phone | +447367430879 |
s.pandanaboyana@nhs.net |
Study information
Study design | Multicentre prospective observational study |
---|---|
Primary study design | Observational |
Secondary study design | Cohort study |
Study setting(s) | Hospital, University/medical school/dental school |
Study type | Treatment |
Participant information sheet | Not applicable (study uses existing data) |
Scientific title | Multicentre prospective study on initial PAin management IN patients with Acute Pancreatitis: PAINAP study protocol |
Study acronym | PAINAP |
Study hypothesis | The PAINAP Study aims to determine current analgesic practices and association between type of analgesic use and their impact on short term outcomes in patients with AP |
Ethics approval(s) | This is prospective observational study. The study was registered with Newcastle hospitals NHS Trust R&D department. The R&D department agreed that given the prospective nature of the study and there is no patient identifiable information, formal ethics approval is not required. |
Condition | Pain management in acute pancreatitis |
Intervention | There will be no change in the clinical course for the participants in this trial given this is a observational study. The patients will be followed for 1 month post recruitment to record any complications. Patient records will be used to: 1. Document current analgesic practice for patients with Acute pancreatitis 2. Examine the relationship between different analgesics and local and systemic complications of AP. |
Intervention type | Other |
Primary outcome measure | Analgesics used during admission (i.e. simple analgesics, mild opioids, strong opioids and epidural analgesia) are measured using patient records at a single time point. |
Secondary outcome measures | Local and systemic complications of AP measured using patient records at a single time point (one month after admission) |
Overall study start date | 01/04/2022 |
Overall study end date | 30/06/2022 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 1,000 |
Total final enrolment | 2200 |
Participant inclusion criteria | 1. Patients aged 18 years and above 2. First presentation with acute pancreatitis of any etiology |
Participant exclusion criteria | 1. Recurrent acute pancreatitis 2. Chronic pancreatitis 3. Post ERCP pancreatitis (will have been given prophylactic NSAIDs) 4. Those on regular opioids, trycyclic antodipressaants and gabapentinoids for other painful conditions, including chronic pain (for other reasons) 5. Pregnancy |
Recruitment start date | 01/04/2022 |
Recruitment end date | 30/06/2022 |
Locations
Countries of recruitment
- Argentina
- Australia
- China
- Cyprus
- Denmark
- Egypt
- England
- Georgia
- Greece
- India
- Italy
- Jordan
- Kyrgyzstan
- New Zealand
- Pakistan
- Portugal
- Romania
- Scotland
- Serbia
- Singapore
- South Africa
- Spain
- Sri Lanka
- Sudan
- Türkiye
- Ukraine
- United Kingdom
- United States of America
- Wales
Study participating centres
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Tremona Road
Southampton
SO16 6YD
United Kingdom
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
Durham Road
Sunderland
SR3 4AG
United Kingdom
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
Edgbaston
Birmingham
B15 2TH
United Kingdom
Glasgow
G4 0SF
United Kingdom
Melbourne
VIC 3076
Australia
Meadowbrook
QLD 4131
Australia
Melbourne
VIC 3050
Australia
St Leonards
NSW 2065
Australia
Hong Kong
999077
China
Romford
RM1 2BA
United Kingdom
Ipswitch
IP3 9GJ
United Kingdom
Redhill
RH1 5RH
United Kingdom
Portsmouth Road
Frimley
Camberley
GU16 7UJ
United Kingdom
Gorleston
Great Yarmouth
NR31 6LA
United Kingdom
Leicester
LE5 4PW
United Kingdom
Oxford Road
Manchester
M13 9WL
United Kingdom
Taunton
TA1 5DA
United Kingdom
Southmead Road
Westbury-on-trym
Bristol
BS10 5NB
United Kingdom
Cramlington
NE23 6NZ
United Kingdom
Watford Road
Harrow
HA1 3UJ
United Kingdom
Derriford Road
Derriford
Plymouth
PL6 8DH
United Kingdom
Sherriff Hill
Gateshead
NE9 6SX
United Kingdom
Barrack Road
Exeter
EX2 5DW
United Kingdom
Marlborough Street
Bristol
BS1 3NU
United Kingdom
Wexham
Slough
SL2 4HL
United Kingdom
Magdala Avenue
London
N19 5NF
United Kingdom
Tbilisi
0186
Georgia
Pinerolo
10064
Italy
Monza
20900
Italy
Zingonia
24040
Italy
Rome
00168
Italy
Caserta
81100
Italy
Milan
Via Antonio di Rudinì, 8, 20142 Milano MI, Italy
Italy
Milan
20157
Italy
Andria
70031
Italy
Cagliari
09121
Italy
Treviso
31100
Italy
Cagliari
09124
Italy
Pisa
56126
Italy
Auckland
1023
New Zealand
Ashburton
7700
New Zealand
Almada
2805-267
Portugal
Dumfries
Dumfries and Galloway
DG2 8RX
United Kingdom
Old Dalkeith Road
Edinburgh
Lothian
EH16 4SA
United Kingdom
Singapore
119074
Singapore
Johannesburg
1864
South Africa
Valladolid
47003
Spain
Madrid
28805
Spain
Pittsburgh
15231
United States of America
Cardiff
CF14 4XW
United Kingdom
Buenos Aires
C1061AAT CABA
Argentina
Sichuan
610041
China
7120001
Egypt
Thessalonika
541 24
Greece
Athens
115 27
Greece
Iraklio
715 00
Greece
265 04
Greece
500032
India
New Dehli
110002
India
Chandigarh
160012
India
Messina
98124
Italy
Roma
00161
Italy
Trieste
34149
Italy
Milan
20013
Italy
Naples
80147
Italy
Gravedona
22015
Italy
Rome
00185
Italy
Parma
43121
Italy
Vimercate
20871
Italy
Leece
73100
Italy
Amman
261
Jordan
Bishkek
720030
Kyrgyzstan
Karachi City
75600
Pakistan
Jamshoro
76090
Pakistan
Lahore
54000
Pakistan
București
041915
Romania
Belgrade
11160
Serbia
Vigo
36312
Spain
Asturias
33394
Spain
Dehiwala-Mount Lavinia
10350
Sri Lanka
Khartoum
JH62+FPW
Sudan
Samsun
55090
Türkiye
Chernivtsi
58002
Ukraine
Lviv
79000
Ukraine
58000
Ukraine
Nanachang
330030
China
Lleida
25198
Spain
Headington
Oxford
OX3 9DU
United Kingdom
Aalborg
9000
Denmark
St Thomas Street
London
SE1 9RT
United Kingdom
4564-007
Portugal
Athens
106 76
Greece
Zaragoza
50009
Spain
Durham
DH1 5TWD
United Kingdom
Herries Road
Sheffield
S5 7AU
United Kingdom
South Brisbane
QLD 4101
Australia
Aberdeen
AB25 2ZN
United Kingdom
Cork
T12 WE28
United Kingdom
Calow
Chesterfield
S44 5BL
United Kingdom
Beckett Street
Leeds
LS9 7TF
United Kingdom
121001
Pakistan
Aosta
11100
Italy
Darlington
DL3 6HX
United Kingdom
Larnaca
6301
Cyprus
Birminham
B18 7QH
United Kingdom
London Road
Reading
RG1 5AN
United Kingdom
Milan
20132
Italy
Amman
11942
Jordan
London
SE13 6LH
United Kingdom
Burnley
BB10 2PQ
United Kingdom
Rishikesh
249203
India
Sponsor information
Hospital/treatment centre
Newcastle Joint Research Office
1st Floor Regent Point
Regent Farm Road
Gosforth
Newcastle upon Tyne
NE3 3HD
England
United Kingdom
Phone | +44 1912448005 |
---|---|
aaron.jackson@nhs.net | |
Website | http://www.newcastle-hospitals.org.uk/hospitals/freeman-hospital.aspx |
https://ror.org/05p40t847 |
Funders
Funder type
Other
No information available
Results and Publications
Intention to publish date | 01/08/2023 |
---|---|
Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Available on request |
Publication and dissemination plan | Manuscripts are currently under preparation. Planned publication in a high-impact peer-reviewed journal. |
IPD sharing plan | The datasets generated during and analysed during the current study are/will be available upon request from Mr Sanjay Pandanaboyana, s.pandanaboyana@nhs.net |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Protocol file | version 2 | 23/02/2022 | 28/04/2023 | No | No |
Additional files
Editorial Notes
28/04/2023: Trial's existence confirmed by Newcastle upon Tyne Hospitals NHS Trust.