General or Spinal Anaesthetic for Vaginal Surgery in Pelvic Floor Disorders (GOSSIP): a feasibility randomised controlled trial

Abstract

This study has demonstrated that a full RCT is feasible and should focus on the length of hospital stay in a subgroup of patients undergoing vaginal surgery where SA may help to facilitate enhanced recovery or day surgery.

Local anaesthetics and regional anaesthesia versus conventional analgesia for preventing persistent postoperative pain in adults and children

“…Study authors’ responses provided additional unpublished information for some studies (Can 2013; Fassoulaki 2000; Fassoulaki 2001; Gacio 2016; Gundes 2000; Ibarra 2011; Lavand’homme 2007; Purwar 2015; Senturk 2002). We excluded three studies for pseudo-randomization (Bach 1988; da Costa 2011; Nikolajsen 1997) (Appendix 9).…”

“…There was a trend toward more adequate addressing of incomplete outcome data in more recent studies (Albi-Feldzer 2013; Bell 2001; Blumenthal 2005; Brown 2004; Can 2013; Comez 2015; Dogan 2016; Fassoulaki 2000; Fassoulaki 2005; Fassoulaki 2016; Gacio 2016; Grigoras 2012; Gundes 2000; Gupta 2006; Kairaluoma 2006; Karanikolas 2006; Karmakar 2014; Kurmann 2015; Lavand’homme 2007; McKeen 2014; Mounir 2010; O’Neill 2012; Okur 2016; Purwar 2015; Shahin 2010; Singh 2007; Sprung 2006; Terkawi 2015b; Vrooman 2015; Weber 2007; Xu 2017). compared to those that are older (Katsuly-Liapis 1996; Katz 1996; Katz 2004; Lavand’homme 2005; Paxton 1995; Senturk 2002).…”

“…We performed an inclusive analysis on the effect of the intervention on PPP in hysterectomy, pooling 297 participants from three studies (Purwar 2015; Sprung 2006; Wodlin 2011) performed across the above named time points (Analysis 1.11). Each study recorded the pain data as the bodily pain subcomponent of the Short Form Health Survey (SF-36) questionnaire, which is a continuous outcome, and thus we used the mean difference as the out-come measure.…”

“…The inclusive analysis of two studies (Brown 2004; Gupta 2006), reporting continuous outcomes for prostatectomy were inconclusive, with a SMD of 0.06 (95% CI −0.26 to 0.38) (Analysis 1.10), as were those pooling three studies (Purwar 2015; Sprung 2006; Wodlin 2011), for hysterectomy, with a MD of 1.70, 95% CI (−1.06 to 4.46) (Analysis 1.11). A subgroup comparison pooling two studies (Grigoras 2012; Terkawi 2015b), with 97 participants showed a statistically meaningful benefit of intravenous local anaesthetics in reducing the risk of persistent postsurgical pain after breast surgery with an OR of 0.24 (95% CI 0.08 to 0.69) (Analysis 1.3.2), and a NNTB 4 95% CI (3 to 11) (Summary of findings 5).…”

“…Null bias might cause studies to underestimate the benefit of regional anaesthesia for the prevention of persistent pain after surgery, if the regional anaesthesia interventions were not effectively delivered (Higgins 2011a; Woods 1995). Indeed, a number of included studies reported no improved pain control in the immediate postoperative period in the experimental (regional anaesthesia) group, as evidenced by inconsequential differences in pain scores between groups perioperatively, or similar requirements of rescue analgesic medications between groups in the immediate postoperative period (Barkhuysen 2010; Baudry 2008; Bollag 2012; Can 2013; Choi 2016; Fassoulaki 2000; Ibarra 2011; Ju 2008; Karmakar 2014; Katz 1996; Lam 2015; Lee 2013; Liu 2015; Loane 2012; McKeen 2014; Micha 2012; Purwar 2015; Singh 2013; Smaldone 2010; Terkawi 2015b; Vrooman 2015; Xu 2017; Zhou 2016). Two review authors therefore extracted information on null bias for each included study and documented their judgement with supporting evidence (see: Characteristics of included studies).…”