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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

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

Mr Sanjay Pandanaboyana
Principal Investigator

Level 5
Freeman hospital
Newcastle Upon Tyne
Newcastle upon tyne
NE2 2AW
United Kingdom

ORCiD logo 0000-0003-3099-2197
+447367430879
s.pandanaboyana@nhs.net

Study information

Study designMulticentre prospective observational study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital, University/medical school/dental school
Study typeTreatment
Participant information sheet Not applicable (study uses existing data)
Scientific titleMulticentre prospective study on initial PAin management IN patients with Acute Pancreatitis: PAINAP study protocol
Study acronymPAINAP
Study hypothesisThe 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.
ConditionPain management in acute pancreatitis
InterventionThere 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 typeOther
Primary outcome measureAnalgesics 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 measuresLocal and systemic complications of AP measured using patient records at a single time point (one month after admission)
Overall study start date01/04/2022
Overall study end date30/06/2022

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants1,000
Total final enrolment2200
Participant inclusion criteria1. Patients aged 18 years and above
2. First presentation with acute pancreatitis of any etiology
Participant exclusion criteria1. 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 date01/04/2022
Recruitment end date30/06/2022

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

The Newcastle upon Tyne Hospitals NHS Foundation Trust
Freeman Hospital
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
Nottingham University Hospitals NHS Trust - City Campus
Nottingham City Hospital
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
South Tyneside & Sunderland NHS Ft Sun
Sunderlandchildrenscentre
Durham Road
Sunderland
SR3 4AG
United Kingdom
James Cook University Hospital Laboratory
James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
University Hospitals Birmingham NHS Foundation Trust - Oxford Covid19 Trials
Queen Elizabeth Hospital
Edgbaston
Birmingham
B15 2TH
United Kingdom
Glasgow Royal Infirmary
84 Castle Street
Glasgow
G4 0SF
United Kingdom
Northern Health
185 Cooper St
Melbourne
VIC 3076
Australia
Logan Hospital
Loganlea Road
Meadowbrook
QLD 4131
Australia
Royal Melbourne Hospital
300 Grattan Street
Melbourne
VIC 3050
Australia
Royal North Shore Hospital
Reserve Road
St Leonards
NSW 2065
Australia
Prince of Wales Hospital
Lui Che Woo Clinical Sciences Building (Professorial Block), Ngan Shing St, Sha Tin
Hong Kong
999077
China
Barking, Havering and Redbridge University Hospitals
4 Lyon Road
Romford
RM1 2BA
United Kingdom
East Suffolk and North Essex
100 Mansbrook Blvd
Ipswitch
IP3 9GJ
United Kingdom
East Surrey Hospital
Canada Avenue
Redhill
RH1 5RH
United Kingdom
Frimley Park Hospital Laboratory
Frimley Park Hospital
Portsmouth Road
Frimley
Camberley
GU16 7UJ
United Kingdom
James Paget University Hospital
Lowestoft Road
Gorleston
Great Yarmouth
NR31 6LA
United Kingdom
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
Manchester Royal Infirmary Laboratory
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom
Musgrove Park Hospital (taunton)
Musgrove Park Hospital
Taunton
TA1 5DA
United Kingdom
North Bristol NHS Trust
Southmead Hospital
Southmead Road
Westbury-on-trym
Bristol
BS10 5NB
United Kingdom
Northumbria Specialist Emergency Care Hospital
Northumbria Way
Cramlington
NE23 6NZ
United Kingdom
Northwick Park and St Marks NHS Trust
Northwick Park Hospital
Watford Road
Harrow
HA1 3UJ
United Kingdom
University Hospitals Plymouth NHS Trust
Derriford Hospital
Derriford Road
Derriford
Plymouth
PL6 8DH
United Kingdom
Gateshead - Queen Elizabeth Hospital
Queen Elizabeth Hospital
Sherriff Hill
Gateshead
NE9 6SX
United Kingdom
Royal Devon and Exeter Hospital NHS Trust - Novavax Covid19 Trial
Royal Devon & Exeter Hospital
Barrack Road
Exeter
EX2 5DW
United Kingdom
University Hospitals Bristol and Weston NHS Foundation Trust
Trust Headquarters
Marlborough Street
Bristol
BS1 3NU
United Kingdom
Wexham Park Hospital
Wexham Street
Wexham
Slough
SL2 4HL
United Kingdom
Whittington Health NHS Trust
The Whittington Hospital
Magdala Avenue
London
N19 5NF
United Kingdom
Tbilisi State Medical University
33 Vazha Pshavela Ave
Tbilisi
0186
Georgia
Agnelli Hospital in Pinerolo
Via Brigata Cagliari
Pinerolo
10064
Italy
ASST Monza - San Gerado Hospital
Via G. B. Pergolesi
Monza
20900
Italy
Azioenda Policlinico San Marco
Corso Europa
Zingonia
24040
Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome
Rome
00168
Italy
Hospital of Caserta
Via Ferdinando Palasciano
Caserta
81100
Italy
Hospital San Paolo
Via Antonio di Rudinì, 8
Milan
Via Antonio di Rudinì, 8, 20142 Milano MI, Italy
Italy
Istuto Clinico Sant' Ambrogio
Via Cristina Belgioioso
Milan
20157
Italy
Lorenzo Bonomo Hospital Andria
Viale Istria
Andria
70031
Italy
Ospedale SS Trinità-ASL Cagliari
Via Is Mirrionis
Cagliari
09121
Italy
Treviso Regional Hospital
Piazzale dell'Ospedale
Treviso
31100
Italy
University of Cagliari
Via Università
Cagliari
09124
Italy
University of Pisa
Lungarno Antonio Pacinotti
Pisa
56126
Italy
Auckland City Hospital
2 Park Road, Grafton
Auckland
1023
New Zealand
Canturbury District Health Board
28 Elizabeth Street
Ashburton
7700
New Zealand
Hospital Garcia de Orta
Av. Torrado da Silva
Almada
2805-267
Portugal
Dumfries & Galloway Royal Infirmary
Cargenbridge
Dumfries
Dumfries and Galloway
DG2 8RX
United Kingdom
Royal Infirmary of Edinburgh at Little France
51 Little France Crescent
Old Dalkeith Road
Edinburgh
Lothian
EH16 4SA
United Kingdom
National Univeristy Hospital
5 Lower Kent Ridge Rd
Singapore
119074
Singapore
Chris Hani Baragwanath Academic Hospital
26 Chris Hani Rd, Diepkloof 319-Iq
Johannesburg
1864
South Africa
Hospital Clinico Universitario Valladolid
Av. Ramón y Cajal, 3
Valladolid
47003
Spain
Hosptial Universitation Principe de Asturias
Carretera de Alcalá, s/n
Madrid
28805
Spain
University of Pittsburg Medical Centre
200 Meyran Ave
Pittsburgh
15231
United States of America
Cardiff and Vale UHB
Health Park
Cardiff
CF14 4XW
United Kingdom
DACIM Foundation
Arenales 1640
Buenos Aires
C1061AAT CABA
Argentina
West China Hospital of. Sichuan University
37 Guoxue Ln, Wuhou District, Chengdu
Sichuan
610041
China
Zagzig University
fargn، Shaibet an Nakareyah, Zagazig 2, Ash Sharqia Governorate
7120001
Egypt
Aristotle University of Thessalonika
Thessalonika 541 24, Greece
Thessalonika
541 24
Greece
Laikon General Hospital
Agiou Thoma 17, Athina
Athens
115 27
Greece
University Hospital of Heraklion
Leof. Panepistimiou
Iraklio
715 00
Greece
University of Patras
Πανεπιστημιούπολη Πατρών
265 04
Greece
Hyderabad
Hyderabad
500032
India
Maulana Azad Medical College & Lok Nayak Hospital
2, Bahadur Shah Zafar Marg, near Delhi Gate, Maulana Azad Medical College Campus, Balmiki Basti
New Dehli
110002
India
Post Graduate Institute of Medical Education and Research Chandigarh
Madhya Marg, Sector 12
Chandigarh
160012
India
AOU G Marinak, Policlinic of Messina
Via Consolare Valeria, 1
Messina
98124
Italy
Azienda Ospedaliera Universitara Polinclinico Umberto
Viale del Policlinico, 155
Roma
00161
Italy
Cattinara University Hospital
Strada di Fiume, 447
Trieste
34149
Italy
Giuseppe Fornaroli Hospital
Via al Donatore di Sangue, 50
Milan
20013
Italy
Ospedale Del Mare
Via Enrico Russo, 11
Naples
80147
Italy
Ospedale Moriggia Pelascini - Gravedona
Via Moriggia Pelascini, 3
Gravedona
22015
Italy
Sapienza University of Rome
Piazzale Aldo Moro, 5
Rome
00185
Italy
University of Parma
Str. dell'Università, 12, 43121 Parma PR, Italy
Parma
43121
Italy
Vimercate Hospital
Via Santi Cosma e Damiano, 10
Vimercate
20871
Italy
Vito Fazzi Hospital Leece
Piazza Filippo Muratore, 1
Leece
73100
Italy
AlBashir Hospital
Al Bashir Hospital، Ossamah Ben Zeid St.
Amman
261
Jordan
M. M. Mamakeev, Bishkek
28 Ulitsa Sukhomlinova
Bishkek
720030
Kyrgyzstan
Dr Ziuauddin University Hospital
Karachi Port Trust Hospital, Plot No. 33, Behind، Kemari
Karachi City
75600
Pakistan
Liquiat University of Medical and Health Sciences
C7PC+337
Jamshoro
76090
Pakistan
Mayo Hospital
Hospital Rd, Anarkali Bazaar
Lahore
54000
Pakistan
Bagdasar Arseni Emergency Hospital
Șoseaua Berceni 12
București
041915
Romania
UMC Zvezdara, Belgrade
Dimitrija Tucovića 161
Belgrade
11160
Serbia
Complejo Hospitalario Universitario de Vigo
Estrada de Clara Campoamor, 341
Vigo
36312
Spain
Hospital Universitario de Cabuenes
Los Prados, 395
Asturias
33394
Spain
Colombo South Teaching Hospital
B229 Hospital Rd
Dehiwala-Mount Lavinia
10350
Sri Lanka
Al-Moalem Medical City
JH62+FPW
Khartoum
JH62+FPW
Sudan
Samsun Training and Research Hospital
Kışla, Barış Blv. No:199
Samsun
55090
Türkiye
Bukovinian State Medical University
Teatral'na Square, 2
Chernivtsi
58002
Ukraine
Lviv Regional Hospital
Chernihivska St, 7, Lviv, Lviv Oblast
Lviv
79000
Ukraine
Regional Emergency Hospital
Chernivitsi
58000
Ukraine
Second Affiliated hospital of Nanchang University
190 Jiangling West 2 Rd, Qingyunpu District
Nanachang
330030
China
Hospital Universitario de Santa María
Av. Alcalde Rovira Roure, 44
Lleida
25198
Spain
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Aalborg University Hospital
Hobrovej 18-22
Aalborg
9000
Denmark
The Guys and Lewisham NHS Trust
Guys Hospital
St Thomas Street
London
SE1 9RT
United Kingdom
Centro Hospitalar do Tâmega e Sousa
Avenida do Hospital Padre Américo 210
4564-007
Portugal
Evaggelismos General Hospital
Ipsilantou 45-47
Athens
106 76
Greece
Hospital Clínico Universitario Lozano Blesa
C. de San Juan Bosco, 15
Zaragoza
50009
Spain
University Hospital North Durham
North Road
Durham
DH1 5TWD
United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Northern General Hospital
Herries Road
Sheffield
S5 7AU
United Kingdom
Mater Hospital
Raymond Terrace
South Brisbane
QLD 4101
Australia
Aberdeen Royal Infirmary
Foresterhill Road
Aberdeen
AB25 2ZN
United Kingdom
Mercy University Hospital
Grenville Pl, Centre
Cork
T12 WE28
United Kingdom
Chesterfield Royal Hospital NHS Foundation Trust
Chesterfield Road
Calow
Chesterfield
S44 5BL
United Kingdom
Leeds Teaching Hospitals NHS Trust
St. James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
Asian Institute of Medical Sciences (AIMS) Hospital
Hyderabad
121001
Pakistan
Aosta Valley
Via Ginevra, 3
Aosta
11100
Italy
County Durham and Darlington NHT Foundation Trust
Hollyhurst Rd
Darlington
DL3 6HX
United Kingdom
Larnaka General Hospital
Pandoras
Larnaca
6301
Cyprus
Sandwell and West Birmingham Hospitals NHS Trust
Dudley Road
Birminham
B18 7QH
United Kingdom
Royal Berkshire Hospital
Royal Berkshire Hospital
London Road
Reading
RG1 5AN
United Kingdom
San Raffaele Scientific Institute, Vita Salute San Raffaele University
Via Olgettina, 58
Milan
20132
Italy
Jordan University Hospital
Queen Rania St
Amman
11942
Jordan
University Hospital Lewisham
Lewisham High Street
London
SE13 6LH
United Kingdom
East Lancashire Hospitals NHS Trust
Casterton Ave
Burnley
BB10 2PQ
United Kingdom
All India Institute of Medical Sciences Rishikesh
Virbhadra Road Shivaji Nagar, near Barrage, Sturida Colony
Rishikesh
249203
India

Sponsor information

Newcastle upon Tyne Hospitals NHS Foundation Trust
Hospital/treatment centre

Newcastle Joint Research Office
1st Floor Regent Point
Regent Farm Road
Gosforth
Newcastle upon Tyne
NE3 3HD
England
United Kingdom

+44 1912448005
aaron.jackson@nhs.net
http://www.newcastle-hospitals.org.uk/hospitals/freeman-hospital.aspx
ROR logo https://ror.org/05p40t847

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date01/08/2023
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planManuscripts are currently under preparation. Planned publication in a high-impact peer-reviewed journal.
IPD sharing planThe 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

43565 protocol PAINAP v2 23.02.2022.pdf

Editorial Notes

28/04/2023: Trial's existence confirmed by Newcastle upon Tyne Hospitals NHS Trust.

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