Caesarean Section 2020

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

For the caesarean section review, the Subgroup members were:

E. Roofthooft^1,2

G. P. Joshi³

N. Rawal⁴

M. Van de Velde⁵

1. Consultant, Department of Anesthesiology, GZA Sint-Augustinus Hospital, Antwerp, Belgium.
2. PhD Student, 5. Professor and Chair, Department of Cardiovascular Sciences, KULeuven and UZLeuven, Leuven, Belgium.
3. Professor, Department of Anesthesiology and Pain Management, University of Texas Southwestern Medical Center, Dallas, Texas, USA.
4. Professor, Department of Anesthesiology, Orebro University, Orebro, Sweden.

Caesarean section literature search

• Systematic review of the literature associated with analgesia after caesarean section was carried out between 1 May 2014 and 22 October 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) were searched for studies (Search strategy).
• Included studies were RCTs, systematic reviews and meta-analyses, published in the English language, of analgesic, anaesthetic and surgical interventions for patients who underwent elective caesarean section under neuraxial anaesthesia. Studies were required to measure pain intensity using tools such as the numerical rating scale (NRS) or visual analogue scale (VAS).
• Of 1135 studies identified, 145 studies were selected and included in the qualitative analysis (126 RCTs and 19 systematic reviews) (Summary of literature selection; Included studies).
• 123 studies were excluded after full-text screening.
• The reasons for exclusion were: observational/audit/retrospective (n=32), no pain scores (n=23), no postoperative pain study (n=19), general anaesthesia (n=19), non-elective caesarean section (n=13), letter/case report/editorial (n=8), not in English (n=4), unfinished trial (n=2), not published in full text (n=2), chronic pain (n=1).

Assessments of the quality of study methodology and reporting

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

• Quality assessment, data extraction and data analysis for caesarean section adhered to the PROSPECT methodology (Joshi 2019, http://esraeurope.org/prospect-methodology).
• Pain intensity scores assessed at rest were used as the primary outcome measure.
• We defined a change of more than 10/100 mm 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.
• 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/COX-2-selective inhibitors and ‘baseline’ analgesia (a routine analgesic administered in addition to the study intervention).

Recommendations were made according to PROSPECT methodology (Joshi 2019, http://esraeurope.org/prospect-methodology). This involved a grading of 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 and source of evidence, levels of evidence 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. 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 and routes of administration as well as timing of pain assessments.
• The small size of most studies makes it impossible to draw conclusions about the safety profile of an individual intervention.
• In the majority of included studies, the analgesic intervention was not evaluated against an optimized multimodal analgesic regimen.
• Measuring just pain scores and/or opioid consumption is not sufficient and more comprehensive, patient-centred tools to assess pain relief and functionality would better reflect day-to-day clinical practice but are unfortunately poorly reported in the literature.
• The PROSPECT methodology uses a minimal clinically important difference in pain scores of 1/10, a difference that has never been validated in obstetric patients.
• Most studies include healthy, full-term parturients. Therefore, the recommendations may not be applicable to parturients with co-existing medical conditions such as morbid obesity, chronic pain and preterm delivery.
• The recommendations should not be applied to other patient populations such as emergency or unplanned caesarean section or surgery performed under general anaesthesia.

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 Caesarean section 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).