IV paracetamol as an adjunct to patient-controlled epidural analgesia with levobupivacaine and fentanyl in labour: a randomized controlled study

Background: Use of i. v. paracetamol for postoperative pain is well documented, but it is unclear if it can reduce the consumption of opioids during patient-controlled epidural analgesia (PCEA) in labouring parturients. Methods: In this randomized, double-blind, placebo-controlled clinical trial conducted in a tertiary care hospital, (80)parturients were randomly assigned to two groups of 40 each, to receive either 1000 mg (100 ml) i.v. paracetamol or 100 ml normal saline as placebo, 30 min before the procedure. After insertion of the epidural catheter, all patients received 10 ml of levobupivacaine 0.1% with 2 mu g ml-1 fentanyl, followed by continuous background epidural infusion of 6 ml h-1 with a provision of patient-controlled bolus 5 ml of same drug with a lock-out interval of 12 min. The primary outcome was hourly mean consumption of levobupivacaine and fentanyl mixture (ml.h-1). Secondary outcomes included pain score, sensory and motor block, haemodynamic parameters of mother, duration of second stage of labour, mode of delivery, Apgar scores, foetal heart rate and adverse effects. Results: The hourly mean drug consumption in the Paracetamol group was significantly lower as compared with the Placebo group (7.03 ml.h-1, SD 0.83 vs. 8.12 ml.h-1, SD 1.34; p < 0.001). The mean number of boluses taken were also significantly less in the paracetamol group (1.00, SD 0.93 vs. 1.43, SD 0.90; p = 0.036). Pain scores decreased in both the groups without significant inter-group differences. Conclusions: Use of 1000 mg i.v. paracetamol decreases the mean hourly drug consumption through epidural route. Thus i.v. paracetamol is a safe and effective adjunct to PCEA in labour analgesia. Clinical trial registration: Clinical Trials Registry-India (ext-link-type="uri" xlink:href="http://ctri.nic.in/Clinicaltrials/login.php">http://ctri.nic.in/Clinicaltrials/login.php), trial registration number 2013/09/003968.