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Invasive placebos in research on peripheral nerve blocks: a follow-up study
  1. Sarah Laing1,
  2. Dana L Bolt1,
  3. Laura L Burgoyne1,
  4. Cormac J Fahy1,
  5. Pauline B Wake2 and
  6. Allan M Cyna1
  1. 1Children's Anaesthesia, Women's and Children's Hospital Adelaide, North Adelaide, South Australia, Australia
  2. 2School of Medicine and Health Sciences, University of Papua New Guinea, Boroko, Papua New Guinea
  1. Correspondence to Dr Laura L Burgoyne, Children's Anaesthesia, Women's and Children's Hospital Adelaide, North Adelaide, South Australia, Australia; laura.burgoyne{at}sa.gov.au

Abstract

Introduction The Serious Harm and Morbidity “SHAM” grading system has previously been proposed to categorize the risks associated with the use of invasive placebos in peripheral nerve block research. SHAM grades range from 0 (no potential complications, eg, using standard analgesia techniques as a comparator) through to 4 (risk of major complications, eg, performing a sub-Tenon’s block and injecting normal saline). A study in 2011 found that 52% of studies of peripheral nerve blocks had SHAM grades of 3 or more.

Methods We repeated the original study by allocating SHAM grades to randomized controlled studies of peripheral nerve blocks published in English over a 22-month period. Documentation was made of the number of study participants, age, number of controls, body region, adverse events due to invasive placebos and any discussion regarding the ethics of using invasive placebos. We compared the proportion of studies with SHAM grades of 3 or more with the original study.

Results In this current study, 114 studies fulfilled the inclusion criteria, 5 pediatric and 109 adult. The SHAM grade was ≥3 in 38 studies (33.3%), with 1494 patients in these control groups collectively. Several studies discussed their reasons for choosing a non-invasive placebo. No pediatric studies had a SHAM grade of ≥3.

Conclusions The use of invasive placebos that may be associated with serious risks in peripheral nerve block research has decreased in contemporary peripheral nerve block research.

  • anesthesia
  • local
  • ethics
  • nerve block

Data availability statement

Data are available in a public, open access repository. Data were gleaned via a PubMed search and is freely available to the public.

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Data availability statement

Data are available in a public, open access repository. Data were gleaned via a PubMed search and is freely available to the public.

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Footnotes

  • Twitter @LauraBurgoyne1

  • Contributors SL made a substantial contribution to the conception and design of the work and the acquisition, analysis and interpretation of data. She was involved in drafting the work and revising it critically for important intellectual content. She approved the final version published. DLB made a substantial contribution to the conception and design of the work and the acquisition, analysis and interpretation of data. She was involved in revising it critically for important intellectual content. She approved the final version published. LLB made a substantial contribution to the acquisition, analysis and interpretation of data. She was involved in drafting the work and revising it critically for important intellectual content. She approved the final version published. CJF made a substantial contribution to the conception and design of the work and the analysis and interpretation of data. He was involved in revising it critically for important intellectual content. He approved the final version published. PBW made a substantial contribution to the conception and design of the work and interpretation of data. She was involved in revising it critically for important intellectual content. She approved the final version published. AMC made a substantial contribution to the conception and design of the work and the analysis and interpretation of data. He was involved in revising it critically for important intellectual content. He approved the final version published.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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