None listed
Conditions
Brief summary
Currently, opinion amongst obstetric anaesthetists is divided as to whether an intravenous (IV) route is superior to the per rectum (PR) route for perioperative mangagement of post caesarean section pain. An audit of the mean total 48 hour opioid requirements post caesaren section was undertaken at The Northern Hospital during March 2014. This did not reveal a difference in the mean opioid requirement between the two different routes of analgesia administration. Despite this, there is a significant increased cost associated with the use of IV analgesia. It has been estimated that for every 4,000 deliveries, by not using IV analgesia, a cost saving of $20,000.00 will result. Therefore, we wish to conduct a randomised controlled trial, using current Australian TGA approved medications and formulations, in line with current obstetric anaesthesia practice to determine if the IV route provides superior analgesia. As such, we would expect to find a 20% decrease in total 48 hour opioid consumption when the IV route is compared to the PR route. Statistical anlaysis of the prior audit has determined that we will need to recruit 50 women into each arm of this trial.
Interventions
Perioperative analgesia:
Intravenous arm of the trial:
1 g paracetamol
40 mg parecoxib
20 mg oxycontin orally in the post anaesthesia care unit
IV paracetamol and IV parecoxib are given by the attending anaesthetist after delivery of the neonate, prior to the parturient leaving the operating theatre to be managed in the Postoperative Care Unit (PACU). IV paracetamol is given over 10 minutes, whereas IV parecoxib is often given as a push.
As per this study protocol, there are no specific analge
Perioperative analgesia: Intravenous arm of the trial: 1 g paracetamol 40 mg parecoxib 20 mg oxycontin orally in the post anaesthesia care unit IV paracetamol and IV parecoxib are given by the attending anaesthetist after delivery of the neonate, prior to the parturient leaving the operating theatre to be managed in the Postoperative Care Unit (PACU). IV paracetamol is given over 10 minutes, whereas IV parecoxib is often given as a push. As per this study protocol, there are no specific analgesic requirements, however, it is usual practice for the anaesthetist to chart on the patient's medical chart, either Targin or Oxycontin 10-20 mg twice daily and paracetamol 1g four times daily as a regular dose. A non-steroidal anti-inflammatory drug (NSAID), either ibuprofen 400 mg three times daily or diclofenac 100 mg three times daily is charted either as a regular dose, or as required, oxycodone 5 - 10 mg as required is charted and occasionally tramadol 50 - 100 mg four times daily as required is charted as well. All of these medications are given once the patient has left PACU and is being managed on the ward.
Sponsors
Darren Lowen
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
Caesarean section either elective or emergency
Exclusion criteria
Patient refusal
Outcome results
None listed