Evidence map›Paper›PMID 31292172›Full record

Trial reportBMJ open2019

Randomised controlled trial to investigate the effectiveness of thoracic epidural and paravertebral blockade in reducing chronic post-thoracotomy pain (TOPIC): a pilot study to assess feasibility of a large multicentre trial.

Joyce Yeung, Lee Middleton, Kostas Tryposkiadis, Amy Kerr, Jane Daniels, Babu Naidu, Teresa Melody, Andreas Goebel, Matthew Wilson, Sajith Kumar and 5 more

Erratum issuedOpen access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.1field-weighted citation impact, top 22% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 16 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 9 institutions in 1 country.

Joyce YeungWarwick Medical School, University of Warwick, Coventry, UK.ORCID 0000-0003-2950-4758
Lee MiddletonSchool of Health and Population Sciences, University of Birmingham, Birmingham, UK.
Kostas TryposkiadisBirmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
Amy KerrDepartment of Thoracic Surgery, Birmingham Heartlands Hospital, University Hospital Birmingham NHS Foundation Trust, Birmingham, UK.
Jane DanielsNottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.
Babu NaiduDepartment of Thoracic Surgery, Birmingham Heartlands Hospital, University Hospital Birmingham NHS Foundation Trust, Birmingham, UK.
Teresa MelodyAcademic Department of Anaesthesia, Critical Care, Pain and Resuscitation, Birmingham Heartlands Hospital, University Hospital Birmingham NHS Foundation Trust, Birmingham, UK.
Andreas GoebelUniversity of Liverpool, Institute of Translational Medicine, Liverpool, UK.
Matthew WilsonHealth Services Research, University of Sheffield, Sheffield, UK.
Sajith KumarAcademic Department of Anaesthesia, Critical Care, Pain and Resuscitation, Birmingham Heartlands Hospital, University Hospital Birmingham NHS Foundation Trust, Birmingham, UK.
Lajos SzentgyorgyiDepartment of Anaesthesia, University Hospital of South Manchester NHS Foundation Trust, Manchester, UK.
Sarah FlanaganInstitute of Applied Health Research, University of Birmingham, Birmingham, UK.
Rajesh ShahDepartment of Thoracic Surgery, University Hospital of South Manchester NHS Foundation Trust, Manchester, UK.
Antony WorrallAcademic Department of Anaesthesia, Critical Care, Pain and Resuscitation, Birmingham Heartlands Hospital, University Hospital Birmingham NHS Foundation Trust, Birmingham, UK.
Fang GaoAcademic Department of Anaesthesia, Critical Care, Pain and Resuscitation, Birmingham Heartlands Hospital, University Hospital Birmingham NHS Foundation Trust, Birmingham, UK.
Heartlands Hospital · GBManchester University NHS Foundation Trust · GBUniversity Hospitals Birmingham NHS Foundation Trust · GBUniversity of Birmingham · GBCancer Research UK Clinical Trials Unit · GBUniversity of Liverpool · GBUniversity of Nottingham · GBUniversity of Sheffield · GBUniversity of Warwick · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThoracotomy is considered one of the most painful surgical procedures. The incidence of chronic post-thoracotomy pain (CPTP) is up to 50%. Paravertebral blockade (PVB) may be superior to thoracic epidural blockade (TEB) in preventing CPTP. The specific objective of this pilot study was to assess the feasibility of conducting a larger trial to determine whether PVB at thoracotomy is more effective in reducing CPTP compared with TEB.

designA randomised, parallel, external pilot study was conducted to assess whether a large randomised trial of TEB and PVB with CPTP as the primary outcome is feasible.

settingTwo adult thoracic centres in the UK.

participantsAll adult patients admitted for elective open thoracotomy. Participants were excluded if they were American Society of Anesthesiologists physical status IV or V; or if there is contraindication to local anaesthetics; infection near the proposed puncture site; coagulation/thoracic spine disorders; required chest wall resection or emergency thoracic surgery or had a previous thoracotomy.

resultsAll patients presenting for thoracotomy were screened over a 12-month period with 194 found to be eligible. Of these, 69 (36%) were randomised (95% CI 29% to 42%). Discounting five participants who died, 54 of 64 participants (84%) returned questionnaire booklets at 6 months. The number of participants indicating at least a moderate level of chest pain at 6 months was lower with PVB but with high levels of uncertainty (RR: 0.7; 95% CI 0.3 to 1.7 for worst pain; RR: 0.3; 95% CI 0.0 to 2.8 for average pain). There were no safety concerns.

conclusionsA large, multicentre randomised controlled trial of PVB versus TEB is feasible as it is possible to randomise and follow up participants with high fidelity. Pain scores were lower on average with PVB compared with TEB but a much larger trial is required to confirm this reliably. TRIAL REGISTRATION NUMBER: ISRCTN45041624.

Indexed as

AdultAgedAnalgesia, EpiduralChronic PainFeasibility StudiesFemaleHumansLung NeoplasmsMaleMiddle AgedNerve BlockPain MeasurementPilot ProjectsPostoperative PainThoracic VertebraeThoracotomyadult anaesthesiaclinical trialspain managementthoracic surgery

Identifiers

PMID31292172
PMCPMC6624049
OpenAlexW2959796357

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.