Study protocol for a randomised controlled trial to investigate the effectiveness of thoracic epidural and paravertebral blockade in reducing chronic post-thoracotomy pain: 2 (TOPIC 2)

Ben Shelley; Andreas Goebel; Stephen Grant; Louise Jackson; Hugh Jarrett; Marcus Jepson; Amy Kerr; Nandor Marczin; Rajnikant Mehta; Teresa Melody; Lee Middleton; Babu Naidu; Lajos Szentgyorgyi; Sarah Tearne; Ben Watkins; Matthew Wilson; Andrew Worrall; Joyce Yeung; Fang Gao Smith

doi:10.1186/s13063-023-07463-1

Study protocol for a randomised controlled trial to investigate the effectiveness of thoracic epidural and paravertebral blockade in reducing chronic post-thoracotomy pain: 2 (TOPIC 2)

Ben Shelley, Andreas Goebel, Stephen Grant, Louise Jackson, Hugh Jarrett, Marcus Jepson, Amy Kerr, Nandor Marczin, Rajnikant Mehta, Teresa Melody, Lee Middleton, Babu Naidu, Lajos Szentgyorgyi, Sarah Tearne, Ben Watkins, Matthew Wilson, Andrew Worrall, Joyce Yeung, Fang Gao Smith^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

57 Downloads (Pure)

Abstract

Background: Thoracotomy is considered one of the most painful surgical procedures and can cause debilitating chronic post-surgical pain lasting months or years postoperatively. Aggressive management of acute pain resulting from thoracotomy may reduce the likelihood of developing chronic pain. This trial compares the two most commonly used modes of acute analgesia provision at the time of thoracotomy (thoracic epidural blockade (TEB) and paravertebral blockade (PVB)) in terms of their clinical and cost-effectiveness in preventing chronic post-thoracotomy pain.

Methods: TOPIC 2 is a multi-centre, open-label, parallel group, superiority, randomised controlled trial, with an internal pilot investigating the use of TEB and PVB in 1026 adult (≥ 18 years old) patients undergoing thoracotomy in up to 20 thoracic centres throughout the UK. Patients (N = 1026) will be randomised in a 1:1 ratio to receive either TEB or PVB. During the first year, the trial will include an integrated QuinteT (Qualitative Research Integrated into Trials) Recruitment Intervention (QRI) with the aim of optimising recruitment and informed consent. The primary outcome is the incidence of chronic post-surgical pain at 6 months post-randomisation defined as ‘worst chest pain over the last week’ equating to a visual analogue score greater than or equal to 40 mm indicating at least a moderate level of pain. Secondary outcomes include acute pain, complications of regional analgesia and surgery, health-related quality of life, mortality and a health economic analysis.

Discussion: Both TEB and PVB have been demonstrated to be effective in the prevention of acute pain following thoracotomy and nationally practice is divided. Identification of which mode of analgesia is both clinically and cost-effective in preventing chronic post-thoracotomy pain could ameliorate the debilitating effects of chronic pain, improving health-related quality of life, facilitating return to work and caring responsibilities and resulting in a cost saving to the NHS.

Trial registration: NCT03677856 [ClinicalTrials.gov] registered September 19, 2018. https://clinicaltrials.gov/ct2/show/NCT03677856. First patient recruited 8 January 2019.

Original language	English
Article number	748
Number of pages	13
Journal	Trials
Volume	24
Issue number	1
DOIs	https://doi.org/10.1186/s13063-023-07463-1
Publication status	Published - 23 Nov 2023

Bibliographical note

Funding:
This trial is funded by the UK National Institute of Health Research Health Technology Assessment Programme (NIHR-HTA), funder’s reference: 16/111/111.

Keywords

Thoracic surgery
Chronic pain
Paravertebral block
Thoracic epidural blockade
Thoracotomy
Anaesthesia

Access to Document

10.1186/s13063-023-07463-1Licence: Creative Commons: Attribution (CC BY)

ShelleyB2023StudyFinal published version, 0.99 MBLicence: Creative Commons: Attribution (CC BY)

A Randomised Controlled Trial to investigate the clinical and cost-effectiveness of Paravertebral Blockade compared with Thoracic Epidural Blockade in reducing Chronic Post-Thoractomy Pain (TOPIC 2) OPEN FOR DISSEMINATION ONLY
Jackson, L. (Co-Investigator), Naidu, B. (Co-Investigator), Gao Smith, F. (Principal Investigator), Jarrett, H. (Co-Investigator), Middleton, L. (Co-Investigator), Khan, A. (Co-Investigator) & Tearne, S. (Co-Investigator)
NIHR EVALUATION, TRIALS AND STUDIES COORDINATING CENTRE
1/05/18 → 31/10/26
Project: Other Government Departments

Cite this

Shelley, B., Goebel, A., Grant, S., Jackson, L., Jarrett, H., Jepson, M., Kerr, A., Marczin, N., Mehta, R., Melody, T., Middleton, L., Naidu, B., Szentgyorgyi, L., Tearne, S., Watkins, B., Wilson, M., Worrall, A., Yeung, J., & Smith, F. G. (2023). Study protocol for a randomised controlled trial to investigate the effectiveness of thoracic epidural and paravertebral blockade in reducing chronic post-thoracotomy pain: 2 (TOPIC 2). Trials, 24(1), Article 748. https://doi.org/10.1186/s13063-023-07463-1

@article{b272662cd07b42b88f7b233e13170ebc,

title = "Study protocol for a randomised controlled trial to investigate the effectiveness of thoracic epidural and paravertebral blockade in reducing chronic post-thoracotomy pain: 2 (TOPIC 2)",

abstract = "Background: Thoracotomy is considered one of the most painful surgical procedures and can cause debilitating chronic post-surgical pain lasting months or years postoperatively. Aggressive management of acute pain resulting from thoracotomy may reduce the likelihood of developing chronic pain. This trial compares the two most commonly used modes of acute analgesia provision at the time of thoracotomy (thoracic epidural blockade (TEB) and paravertebral blockade (PVB)) in terms of their clinical and cost-effectiveness in preventing chronic post-thoracotomy pain. Methods: TOPIC 2 is a multi-centre, open-label, parallel group, superiority, randomised controlled trial, with an internal pilot investigating the use of TEB and PVB in 1026 adult (≥ 18 years old) patients undergoing thoracotomy in up to 20 thoracic centres throughout the UK. Patients (N = 1026) will be randomised in a 1:1 ratio to receive either TEB or PVB. During the first year, the trial will include an integrated QuinteT (Qualitative Research Integrated into Trials) Recruitment Intervention (QRI) with the aim of optimising recruitment and informed consent. The primary outcome is the incidence of chronic post-surgical pain at 6 months post-randomisation defined as {\textquoteleft}worst chest pain over the last week{\textquoteright} equating to a visual analogue score greater than or equal to 40 mm indicating at least a moderate level of pain. Secondary outcomes include acute pain, complications of regional analgesia and surgery, health-related quality of life, mortality and a health economic analysis. Discussion: Both TEB and PVB have been demonstrated to be effective in the prevention of acute pain following thoracotomy and nationally practice is divided. Identification of which mode of analgesia is both clinically and cost-effective in preventing chronic post-thoracotomy pain could ameliorate the debilitating effects of chronic pain, improving health-related quality of life, facilitating return to work and caring responsibilities and resulting in a cost saving to the NHS. Trial registration: NCT03677856 [ClinicalTrials.gov] registered September 19, 2018. https://clinicaltrials.gov/ct2/show/NCT03677856. First patient recruited 8 January 2019.",

keywords = "Thoracic surgery, Chronic pain, Paravertebral block, Thoracic epidural blockade, Thoracotomy, Anaesthesia",

author = "Ben Shelley and Andreas Goebel and Stephen Grant and Louise Jackson and Hugh Jarrett and Marcus Jepson and Amy Kerr and Nandor Marczin and Rajnikant Mehta and Teresa Melody and Lee Middleton and Babu Naidu and Lajos Szentgyorgyi and Sarah Tearne and Ben Watkins and Matthew Wilson and Andrew Worrall and Joyce Yeung and Smith, {Fang Gao}",

note = "Funding: This trial is funded by the UK National Institute of Health Research Health Technology Assessment Programme (NIHR-HTA), funder{\textquoteright}s reference: 16/111/111.",

year = "2023",

month = nov,

day = "23",

doi = "10.1186/s13063-023-07463-1",

language = "English",

volume = "24",

journal = "Trials",

issn = "1745-6215",

publisher = "Springer",

number = "1",

}

Shelley, B, Goebel, A, Grant, S, Jackson, L, Jarrett, H, Jepson, M, Kerr, A, Marczin, N, Mehta, R, Melody, T, Middleton, L , Naidu, B, Szentgyorgyi, L, Tearne, S, Watkins, B, Wilson, M, Worrall, A, Yeung, J & Smith, FG 2023, 'Study protocol for a randomised controlled trial to investigate the effectiveness of thoracic epidural and paravertebral blockade in reducing chronic post-thoracotomy pain: 2 (TOPIC 2)', Trials, vol. 24, no. 1, 748. https://doi.org/10.1186/s13063-023-07463-1

TY - JOUR

T1 - Study protocol for a randomised controlled trial to investigate the effectiveness of thoracic epidural and paravertebral blockade in reducing chronic post-thoracotomy pain

T2 - 2 (TOPIC 2)

AU - Shelley, Ben

AU - Goebel, Andreas

AU - Grant, Stephen

AU - Jackson, Louise

AU - Jarrett, Hugh

AU - Jepson, Marcus

AU - Kerr, Amy

AU - Marczin, Nandor

AU - Mehta, Rajnikant

AU - Melody, Teresa

AU - Middleton, Lee

AU - Naidu, Babu

AU - Szentgyorgyi, Lajos

AU - Tearne, Sarah

AU - Watkins, Ben

AU - Wilson, Matthew

AU - Worrall, Andrew

AU - Yeung, Joyce

AU - Smith, Fang Gao

N1 - Funding: This trial is funded by the UK National Institute of Health Research Health Technology Assessment Programme (NIHR-HTA), funder’s reference: 16/111/111.

PY - 2023/11/23

Y1 - 2023/11/23

N2 - Background: Thoracotomy is considered one of the most painful surgical procedures and can cause debilitating chronic post-surgical pain lasting months or years postoperatively. Aggressive management of acute pain resulting from thoracotomy may reduce the likelihood of developing chronic pain. This trial compares the two most commonly used modes of acute analgesia provision at the time of thoracotomy (thoracic epidural blockade (TEB) and paravertebral blockade (PVB)) in terms of their clinical and cost-effectiveness in preventing chronic post-thoracotomy pain. Methods: TOPIC 2 is a multi-centre, open-label, parallel group, superiority, randomised controlled trial, with an internal pilot investigating the use of TEB and PVB in 1026 adult (≥ 18 years old) patients undergoing thoracotomy in up to 20 thoracic centres throughout the UK. Patients (N = 1026) will be randomised in a 1:1 ratio to receive either TEB or PVB. During the first year, the trial will include an integrated QuinteT (Qualitative Research Integrated into Trials) Recruitment Intervention (QRI) with the aim of optimising recruitment and informed consent. The primary outcome is the incidence of chronic post-surgical pain at 6 months post-randomisation defined as ‘worst chest pain over the last week’ equating to a visual analogue score greater than or equal to 40 mm indicating at least a moderate level of pain. Secondary outcomes include acute pain, complications of regional analgesia and surgery, health-related quality of life, mortality and a health economic analysis. Discussion: Both TEB and PVB have been demonstrated to be effective in the prevention of acute pain following thoracotomy and nationally practice is divided. Identification of which mode of analgesia is both clinically and cost-effective in preventing chronic post-thoracotomy pain could ameliorate the debilitating effects of chronic pain, improving health-related quality of life, facilitating return to work and caring responsibilities and resulting in a cost saving to the NHS. Trial registration: NCT03677856 [ClinicalTrials.gov] registered September 19, 2018. https://clinicaltrials.gov/ct2/show/NCT03677856. First patient recruited 8 January 2019.

AB - Background: Thoracotomy is considered one of the most painful surgical procedures and can cause debilitating chronic post-surgical pain lasting months or years postoperatively. Aggressive management of acute pain resulting from thoracotomy may reduce the likelihood of developing chronic pain. This trial compares the two most commonly used modes of acute analgesia provision at the time of thoracotomy (thoracic epidural blockade (TEB) and paravertebral blockade (PVB)) in terms of their clinical and cost-effectiveness in preventing chronic post-thoracotomy pain. Methods: TOPIC 2 is a multi-centre, open-label, parallel group, superiority, randomised controlled trial, with an internal pilot investigating the use of TEB and PVB in 1026 adult (≥ 18 years old) patients undergoing thoracotomy in up to 20 thoracic centres throughout the UK. Patients (N = 1026) will be randomised in a 1:1 ratio to receive either TEB or PVB. During the first year, the trial will include an integrated QuinteT (Qualitative Research Integrated into Trials) Recruitment Intervention (QRI) with the aim of optimising recruitment and informed consent. The primary outcome is the incidence of chronic post-surgical pain at 6 months post-randomisation defined as ‘worst chest pain over the last week’ equating to a visual analogue score greater than or equal to 40 mm indicating at least a moderate level of pain. Secondary outcomes include acute pain, complications of regional analgesia and surgery, health-related quality of life, mortality and a health economic analysis. Discussion: Both TEB and PVB have been demonstrated to be effective in the prevention of acute pain following thoracotomy and nationally practice is divided. Identification of which mode of analgesia is both clinically and cost-effective in preventing chronic post-thoracotomy pain could ameliorate the debilitating effects of chronic pain, improving health-related quality of life, facilitating return to work and caring responsibilities and resulting in a cost saving to the NHS. Trial registration: NCT03677856 [ClinicalTrials.gov] registered September 19, 2018. https://clinicaltrials.gov/ct2/show/NCT03677856. First patient recruited 8 January 2019.

KW - Thoracic surgery

KW - Chronic pain

KW - Paravertebral block

KW - Thoracic epidural blockade

KW - Thoracotomy

KW - Anaesthesia

U2 - 10.1186/s13063-023-07463-1

DO - 10.1186/s13063-023-07463-1

M3 - Article

SN - 1745-6215

VL - 24

JO - Trials

JF - Trials

IS - 1

M1 - 748

ER -

Study protocol for a randomised controlled trial to investigate the effectiveness of thoracic epidural and paravertebral blockade in reducing chronic post-thoracotomy pain: 2 (TOPIC 2)

Abstract

Bibliographical note

Keywords

Access to Document

Fingerprint

Projects

A Randomised Controlled Trial to investigate the clinical and cost-effectiveness of Paravertebral Blockade compared with Thoracic Epidural Blockade in reducing Chronic Post-Thoractomy Pain (TOPIC 2) OPEN FOR DISSEMINATION ONLY

Cite this