Evidence Review Process - ESRA
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Laminectomy 2020

Evidence Review Process

An explanation of PROSPECT methodology and Working Group processes can be found at the following link: https://esraeurope.org/prospect-methodology

For the laminectomy review, the Subgroup members were:

Laurens Peene1*

Pauline Le Cacheux2*

Axel R. Sauter3,4

Girish P. Joshi5

Helene Beloeil6

  1. Department of Anesthesiology, University Hospitals Leuven, 3000 Leuven, Belgium
  2. Anesthesia and Intensive Care Department, CHU Rennes, 35000 Rennes, France
  3. Division of Emergencies and Critical Care, Department of Anaesthesia, Oslo University Hospital, Oslo, Norway
  4. Department of Anaesthesia and Pain Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
  5. University of Texas Southwestern Medical Center, Dallas, TX 75390-9068, USA
  6. Anesthesia and Intensive Care Department, Inserm, INRA, Univ Rennes, CHU Rennes, CIC 1414 NuMeCan, 35000 Rennes, France

* Laurens Peene and Pauline Le Cacheux equally share first authorship.

Laminectomy literature search

  • Systematic review of the literature associated with analgesia after lumbar laminectomy was carried out between January 1st 2008 and March 31st 2020.
  • The following databases were searched: EMBASE, MEDLINE, Pubmed and Cochrane Databases (Cochrane Central Register of Controlled Trials, Cochrane Database of Abstracts or Reviews of Effects, Cochrane Database of Systematic Reviews) (Search strategy).
  • Included studies were RCTs or systematic reviews of analgesic, anaesthetic and operative interventions, published in the English language assessing pain management for patients undergoing up to two-level lumbar laminectomy. The study was required to measure pain intensity using tools such as the numerical rating scale or visual analogue.
  • Studies were excluded if they reported data pooled from patients undergoing mixed surgical procedures, if no response was received from the authors to provide data tables specifically related to laminectomy and the intended intervention. Only open procedures were deemed eligible; minimal invasive procedures were therefore excluded.
  • Of 7144 records identified, 39 studies were selected and included in the qualitative analysis (Summary of literature selection; Included studies).
  • 15 studies were excluded after full-text screening.
  • The reasons for exclusion: not in English (n=3), microdiscectomy included (n=7), analgesia was not a primary outcome (n=1), surgery included fusion (n=3), published before 1 January 2008 (n=1).

Assessments of the quality of study methodology and reporting

All included studies were assessed for quality according to PROSPECT methodology (Joshi 2019, https://esraeurope.org/prospect-methodology). The study quality assessments for laminectomy are summarised here: Quality assessment table.

  • Data extraction and data analysis for laminectomy adhered to the PROSPECT methodology (Joshi 2019, https://esraeurope.org/prospect-methodology).
  • Pain intensity scores assessed at rest were used as the primary outcome measure.
  • In this study, we defined a change of more than 1 cm/10 cm on the VAS or 1/10 on NRS as clinically relevant.
  • The effectiveness of each intervention for each outcome was evaluated qualitatively by assessing the number of studies showing a significant difference between treatment arms (P<0.05, as reported in the study publication).
  • A meta-analysis was not performed due to heterogeneity in study design and result reporting, restricting pooled analysis.
  • The review also examined whether patients received basic analgesics: paracetamol and NSAIDs or COX-2 selective inhibitors.
  • Recommendations were made according to PROSPECT methodology (Joshi 2019, https://esraeurope.org/prospect-methodology).
  • Recommendations were graded A–D according to the overall level of evidence, as determined by the quality of studies included, consistency of evidence and study design: Relationship between quality of the study and levels of evidence (LoE) and grades of recommendation.
  • The proposed recommendations were sent to the PROSPECT Working Group for review and comments and a modified Delphi approach was used.
  • Recommendations were only given when the intervention was supported by at least two RCTs and consensus of the Working Group.
  • Once a consensus was achieved the lead authors drafted the final document, which was ultimately approved by the Working Group.

The limitations of this review are related to those of the included studies:

  • Considerable heterogeneity between studies regarding variable dosing regimens, variable methods of administration and variable control groups as well as time points of pain assessments.
  • The small size of most studies has the potential for estimation effect and was not adequate to draw valid conclusions concerning the safety profile of the analgesic interventions.
  • The analgesic interventions were not evaluated against a control group that included an optimised multimodal analgesic regimen.

The AGREE II instrument (Brouwers 2010) is used internationally to assess the methodological rigour and transparency of practice guidelines. As far as possible, the methodology of the PROSPECT Laminectomy review meets the requirements of ‘Domain 3: Rigour of development’ of the AGREE II instrument:

  • Systematic methods were used to search for evidence.
  • The criteria for selecting the evidence are clearly described.
  • The strengths and limitations of the body of evidence are clearly described.
  • The methods for formulating the recommendations are clearly described.
  • The health benefits, side effects, and risks have been considered in formulating the recommendations.
  • There is an explicit link between the recommendations and the supporting evidence.
  • The guideline has been externally reviewed by experts prior to its publication. (The evidence and recommendations are made available on the website after peer review and publication).
  • A procedure for updating the guideline is provided. (Methodology is provided so that the systematic review can be updated as required).