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. Recently, a prospective audit was conducted at the Northern Hospital. This audit assigned 50 women to receive IV analgesia and a further 50 women received PR analgesia post caesarean section, which was either an elective or an emergency procedure. Analysis of the data revealed that the group who had received IV analgesia had a lower 48 hour oxycodone usage of 148.9 +/- 36.7 compared to the PR analgesia group, which had a 48 hour oxycodone usage of 170.0 +/- 47.5 mg. This difference is a 12.4% reduction. Despite this apparent difference in opioid requirements, there did not appear to be a difference in pain scores as reflected by the fact that for three of the four pain questionnaires, all of which were unidimensional measurements of pain, there was no statistical difference between the two groups. For the fourth pain questionnaire, which measures the multidimensional aspect of pain, a statistical difference was found favouring the group who had received IV analgesia. Therefore, we wish to expand upon these findings and would like to propose a non-blinded randomised controlled trial comparing the IV route to the PR route. Based on data previously obtained, if the IV route provided better analgesia, we propose that there should be a 20% reduction in the total pain score as determined by the multidimensional pain questionnaire (SF-MPQ).
Interventions
Perioperative analgesia:
Intravenous arm of the trial:
1 g paracetamol
40 mg parecoxib
20 mg oxycontin orally in the post anaesthesia care unit
Intravenous paracetamol and intravenous 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). Intravenous paracetamol is given over 10 minutes, whereas intravenous parecoxib is often given as a push. Any variation to this
Perioperative analgesia: Intravenous arm of the trial: 1 g paracetamol 40 mg parecoxib 20 mg oxycontin orally in the post anaesthesia care unit Intravenous paracetamol and intravenous 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). Intravenous paracetamol is given over 10 minutes, whereas intravenous parecoxib is often given as a push. Any variation to this protocol will be recorded as a protocol deviation. 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
Elective caesarean section
Exclusion criteria
Patient refusal Non English speaking background
Outcome results
None listed