Chalekar 2021.

Study characteristics
Methods	Prospective randomised double‐blind controlled study
Participants	Setting: Obstetrics and Gynaecology Department at Fortis Hospital, Bannerghatta road, Bengaluru, Karnataka, India from June 2014 to June 2015 Sample size: N = 60 Inclusion criteria: American Society of Anesthesiologists (ASA) II parturients, aged 18‐35 years, admitted with term gestation for safe confinement in active labour were included. Also primiparturients with singleton pregnancy, term gestation, cephalic presentation in active first stage of labour willing for epidural analgesia, cervical dilatation >3 cm and <5 cm, aged 18‐35 years, height >145 cm, and Body Mass Index (BMI) 18‐25 kg/m2. Exclusion criteria: Parturients who were unwilling, had medical disorders and pregnancy associated disorders, spine abnormalities and local skin infections, coagulopathies, preterm gestation, non reassuring non stress test, pregnant women with preterm labour or false labour pains, parturients in whom epidural analgesia was inadequate even after 45 minutes of initial bolus, parturients who experience unilateral block, parturients with blood tap during epidural and those with accidental dural puncture.
Interventions	Group I (PIEB) (n=30) parturients received 8 mL of 0.15% ropivacaine with fentanyl 2 µg/mL hourly. Group C (CEI) (n=30) parturients received same solution as continuous infusion immediately.
Outcomes	Primary outcome: LA consumption Secondary outcomes: 1. Level of sensory block 2. Motor block 3. Breakthrough pain 4. Duration of epidural analgesia 5. Maternal satisfaction 6. Mode of delivery 7. Second stage of labour 8. APGAR scores 9. Contraction stress test 10. Pain scores
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Random assignment using sealed envelopes, but method of randomisation was not stated: Quote:"The parturients were then randomly assigned, using sealed envelope method..."
Allocation concealment (selection bias)	Unclear risk	Allocation via sealed envelopes, but it was not stated that the envelopes were opaque: Quote:"The parturients were then randomly assigned, using sealed envelope method..."
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	It was not stated if participants were blinded.  Quote:"Observations were made by an assessor ‘blind’ to the mode of drug administration. The attending anaesthesiologist was informed whenever pain recurred (VAS ≥4) and additional top‐ups of the study drug were given"
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	It was not stated if participants were blinded.  Quote:"Observations were made by an assessor ‘blind’ to the mode of drug administration. The attending anaesthesiologist was informed whenever pain recurred (VAS ≥4) and additional top‐ups of the study drug were given"
Incomplete outcome data (attrition bias) All outcomes	Low risk	No loss to follow‐up or exclusions
Selective reporting (reporting bias)	Low risk	All a priori outcomes reported
Other bias	Low risk	Sample size calculation provided