To compare the pain relief during labour using a epidural local anaesthetic and an opioid versus epidural local anaesthetic and opioid along with intravenous steroid(dexamethasone)
- Conditions
- Age 18 yearsPrimigravidaSingle gestationCephalic presentation at ≥ 36 wk of gestationIn early spontaneous labour (cervical dilation ≤ 5 cm)Baseline pain score 30 (on a 0-100 VAS)
- Registration Number
- CTRI/2014/05/004596
- Lead Sponsor
- GMCH chandigarh
- Brief Summary
Labour is the physiological process associated with severe pain, the multidimensional aspects and intensity of which far exceeds that of other conditions.Although severe pain in healthy parturient is not life-threatening, it can have numerous neuropsychological consequences.The goal of labour analgesia is to provide adequate pain relief without causing any maternal or foetal jeopardy. Continuous epidural analgesia is the most versatile and most commonly employed technique since it can be used for pain relief during labour and for subsequent vaginal delivery as well as analgesia and anaesthesia for ceasarean section, if necessary. The review of literature in the area of labour analgesia indicates that significant progress has been made with the advent of PCEA using a combination of low-concentration long-acting local anaesthetics (bupivacaine, levobupivacaine) and low-dose lipid soluble potent opioids (e.g., fentanyl).studying whether addition of a long-established safe and well-tolerated adjuvant in multimodal postoperative analgesia like dexamethasone by the intravenous route to the intrapartum labour analgesia regime reduces the total hourly consumption of the local anaesthetic-opioid combination by the epidural route.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 80
•American Society of Anesthesiologists (ASA) grade I and II •Age >18 years •Primigravida •Single gestation •Cephalic presentation at ≥ 36 wk of gestation •In early spontaneous labour (cervical dilation ≤ 5 cm) •Baseline pain score > 30 (on a 0-100 VAS) •Able to use PCEA pump •Requesting epidural analgesia for labour.
- •Refusal by parturient.
- •Parturients who had received parenteral opioids in the last 4 hours.
- •Systemic and local sepsis.
- •Deranged coagulation profile.
- •Parturients having multiple pregnancies and premature labour.
- •Obstetric complications (e.g., premature rupture of amniotic membranes).
- •Noncephalic presentations.
- •Allergy to study drugs, i.e. levobupivacaine and fentanyl.
- •H/O peptic ulcer disease.
- •Known case of uncontrolled Diabetes Mellitus.
- •Patient who have received dexamethasone in last 7 days for foetal lung maturity.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hourly average consumption of levobupivacaine and fentanyl mixture, including both continuous background infusion plus bolus doses (in ml) corrected for the duration of labour. At the end of delivery
- Secondary Outcome Measures
Name Time Method Maternal satisfaction and Pain score (VAS) Haemodynamic parameters of mother 5 min for the first 20 min and then every 1 h until delivery Sensory and motor block characteristics Sensory block at midline every 5 min for the first 20 min and then every 1 h until delivery. Foetal heart rate Continuous foetal heart rate monitoring. Apgar score 1 and 5 minute after delivery
Trial Locations
- Locations (1)
GMCH, Chandigarh
🇮🇳Chandigarh, CHANDIGARH, India
GMCH, Chandigarh🇮🇳Chandigarh, CHANDIGARH, IndiaDr Pratibha DubePrincipal investigator9815678146pratibhadube.dube@gmail.com