None listed
Conditions
Brief summary
Chronic postsurgical pain (CPSP) after caesarean section surgery occurs in approximately one in five women. In Australia about one-third of women who give birth have caesarean section surgery. This means that in Australia over the next five years nearly 105,000 young women will be affected by CPSP. The impacts of this condition are significant with reduction in quality of life, reduced maternal-baby bonding, decreased mobility, and social isolation, and present an added burden for women facing the physical and emotional challenges of motherhood. The problem of chronic pain also has other complications including the risk of dependence on morphine-based medications, poor mental health and loss of work productivity. Due to the far-reaching implications of chronic pain, there is an ongoing search for ways to prevent this. Data suggests that different types of anaesthesia and management around the time of surgery may minimise the risk of patients developing chronic pain following surgery. A local anaesthetic drug, lignocaine, which has a long history of use and is safe in pregnancy and breastfeeding, has shown promising benefits in reducing chronic pain when it is given with an anaesthetic during other types of abdominal surgery. It has not been used in caesarean section surgery however we hope that it could be used in this surgery to reduce CPSP. Before conducting a large study in this area, we need to collect information about the safety of lignocaine in women having caesarean section, information about whether a study is feasible on a large scale, and what the rate of CPSP is in women in contemporary Australia.
Interventions
Intravenous lignocaine: Women allocated to the intravenous lignocaine group (intervention group) will receive a lignocaine bolus of 1.0 mg/kg over 15 minutes followed by a lignocaine infusion of 1.5 mg/kg/hour (based on their current day of surgery weight). The bolus dose will commence immediately after the spinal anaesthetic injection at the same time as the prophylactic phenylephrine intravenous infusion is commenced (routine care). The infusion will be ceased immediately prior to transfer fro
Intravenous lignocaine: Women allocated to the intravenous lignocaine group (intervention group) will receive a lignocaine bolus of 1.0 mg/kg over 15 minutes followed by a lignocaine infusion of 1.5 mg/kg/hour (based on their current day of surgery weight). The bolus dose will commence immediately after the spinal anaesthetic injection at the same time as the prophylactic phenylephrine intravenous infusion is commenced (routine care). The infusion will be ceased immediately prior to transfer from the operating table to the participants bed in the operating theatre (prior to transfer to the post-anaesthesia recovery area). A study investigator will ensure that randomised participants receive the infusion. In the post-anaesthesia care unit blood samples will be taken to measure the intravenous concentration of the intervention (lignocaine)
Sponsors
Royal Women's Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
Pregnant people. Age 18 years or greater, age 50 years or less; Gestational age 36 weeks; or greater Undergoing elective caesarean section surgery under neuraxial anaesthesia (spinal anaesthesia); Weight (on day of caesarean section surgery) 50 kg or greater, 120 kg or less
Exclusion criteria
American Society of Anesthesiology (ASA) class III, IV; Preoperative opioid therapy in the seven days prior to surgery; History of recreational drug use in the last 12 months prior to surgery; Allergies to local anaesthetics, morphine, fentanyl, paracetamol; Allergy or adverse reaction to non-steroidal anti-inflammatory drugs (NSAIDs); Body mass index (on day of caesarean section surgery) 45 kg/m¬2 or less.; Renal or liver impairment; Placental adhesive disorder defined on ultrasound and/or MRI; Known uterine fibroids.
Outcome results
None listed