Prophylactic norepinephrine infusion or leg wrapping for postspinal hypotension in elective caesarean delivery: A randomised, double-blind, placebo-controlled trial.

BACKGROUND

Because of its alpha and beta agonist properties, norepinephrine infusion is currently being studied for the prevention of spinal hypotension during caesarean delivery. Vasopressor infusions are not always possible if there is an unavailability of infusion pumps. Leg wrapping with crepe bandage is an effective technique for prevention of postspinal hypotension and could be useful in resource-poor settings.

OBJECTIVE

The aim of this study was to compare the incidence of hypotension with norepinephrine infusion or leg wrapping with a control group in women undergoing caesarean delivery with spinal anaesthesia.

DESIGN

Randomised, double-blind, controlled trial.

SETTING

Single centre, tertiary level institute, India.Study period 3 April 2018 to 31 March 2019.

PATIENTS: One hundred and forty-four women aged 19 to 40 years with a singleton pregnancy.

INTERVENTION: In group Leg Wrapping, crepe bandage was applied tightly from metatarsus to groin. Group Norepinephrine and the control group received sham leg wrapping. In group Norepinephrine, the women received a norepinephrine infusion according to their body weight, while group Leg Wrapping and the control group received a 0.9% normal saline infusion at a similar rate. All three groups received a 500 ml co-load of Ringer's solution over 15 min. Noninvasive SBP was monitored every 2 min until delivery, and every 5 min thereafter. Any hypotensive event (SBP < 20% of baseline) was treated with an intravenous bolus of norepinephrine (7.5 μg).

MAIN OUTCOME MEASURES: The primary outcome was the incidence of hypotension. The secondary outcomes were performance error measurements, and the incidences of hypertension, bradycardia, norepinephrine rescue bolus and neonatal outcomes.

RESULTS

The incidences of hypotension were significantly lower in the norepinephrine infusion group and the leg wrapping groups than the control group (P values 0.021 for both). Performance error calculations showed that SBP was maintained closer to baseline with the norepinephrine infusion.

CONCLUSION

Norepinephrine infusion and leg wrapping can both reduce the incidence of postspinal hypotension during elective caesarean delivery compared with saline infusion alone.

TRIAL REGISTRATION: Clinical trial number and registry URL: CTRI/2018/04/012917 registered at Clinical Trial Registry of India http://www.ctri.nic.in/Clinicaltrials/login.php.