Purwar 2015.

Methods	Randomized clinical trial Sequence generation by computer‐generated random numbers Follow‐up: 3 months
Participants	Participants: 60 adults in a university setting in the UK Operation: vaginal surgery for pelvic floor disorders (tape, repair, or hysterectomy) 2 groups, size: 29/31 Age (± SD), group 1, 2: 65.1 (12.5), 60.6 (11.5) All women Exclusion criteria: American Society of Anesthesiologists (ASA) grade 3, contraindication to Spinal Anesthesia (SA), a lack of capacity to provide consent, and an inability to read and write in English.
Interventions	Group 1 (GA): anaesthesia was induced with propofol (3 mg/kg) and maintained with isoflurane in oxygen‐enriched air to achieve an inspired oxygen fraction (FiO2) of 33%. Ondansetron 4 mg IV was given as prophylaxis against postoperative nausea and vomiting. The operating surgeon was a urogynaecology consultant (JC) or specialist trainee signed off as competent for independent practice for the type of surgery performed. Anaesthesia was provided by 1 of two anaesthetic specialists (NT or AF). Anaesthesia was augmented by surgical infiltration with LA solution comprising 30 mL of 0.5% levobupivacaine, 27 mL of normal saline and 3 mL of adrenaline 1:10,000. Hypotension (systolic blood pressure < 85 mmHg) was treated with metaraminol in aliquots of 0.5 mg and bradycardia (heart rate < 60 beats per min) was treated with glycopyrrolate in aliquots of 200 µg. Women were prescribed ibuprofen 400 mg every 4 h orally with food when required and either co‐codamol (30/500) two tablets every 4 h or paracetamol 1 g IV or orally every 4 h. If pain was not controlled with the above regimen, morphine was prescribed. Postoperative nausea and vomiting were initially treated with prochlorperazine 12.5 mg IM every 6 h with ondansetron 4 mg to8 mg IV if required. Group 2 (SA): a 25‐G Whitacre needle was inserted at the L3‐L4 interspace following skin infiltration with 1% lidocaine, under aseptic conditions, the participant in the sitting position. Initially, the SA regimen consisted of 1 mL of 0.5% hyperbaric bupivacaine with 10 µg of fentanyl diluted to a volume of 3.0 mL using normal saline. Participants remained in the sitting position for 5 min following the introduction of SA. However, owing to suboptimal pain control in the first few participants, the protocol was revised and the spinal anaesthetic mixture was amended to 2.0 mL 0.5% heavy bupivacaine with 10 µg fentanyl, diluted to 3 mL, with the participant’s position immediately changed to semi‐recumbent following spinal injection. Participants’ complaints of pain were treated with IV fentanyl in aliquots of 50 µg. Additional intraoperative sedation was achieved by IV midazolam as required. Levobupivacaine was used to augment anaesthesia as described above. Hypotension was treated as described above. Adjuvants: fentanyl Immediate post‐op pain control: no improvement
Outcomes	Dichotomous: none Continuous: VAS score, SF‐36 Other reported: VAS in the perioperative period 2 h, 24 h, 2 weeks, Incontinence Modular Questionnaire on Vaginal Symptoms (ICIQ‐VS), data regarding the time taken from the induction of anaesthesia to commencing surgery, operating time, duration of stay in the postoperative recovery room in min, use of analgesia postoperatively, and length of hospital stay
Notes	We acknowledge the response provided by the study author regarding blinding, randomization, allocation concealment and source of funding and conflict of interest statement. Funding sources: "this study was funded by a Research Award from the North Staffordshire Medical Institute, UK." Conflicts of interest: the study authors have no conflicts of interest.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "an internet‐based sequence allocation randomisation was carried out by the Nottingham (UK) Clinical Trials Support Unit with random permuted blocks of randomly varying size."
Allocation concealment (selection bias)	High risk	Quote: "The anaesthetist was informed of the random allocation allocated by the computer."
Blinding of participants and personnel (performance bias) All outcomes	High risk	The study author responded, quote: "Owing to the nature of the interventions, it was not possible to blind either patients or the assessing team to the intervention given."
Blinding of outcome assessment (detection bias) All outcomes	High risk	Outcome assessors not blinded
Incomplete outcome data (attrition bias) All outcomes	High risk	Significant attrition
Selective reporting (reporting bias)	Low risk	No subgroup analysis was performed
Null bias	High risk	Quote: "no statistically significant differences were noted between the groups with regard to pain..."