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Patient controlled oral analgesia (PCOA) following Caesarean delivery.

Patient controlled oral analgesia (PCOA) for women following caesarean section delivery: A Non inferiority study.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619001345178
Enrollment
38
Registered
2019-10-01
Start date
2019-07-22
Completion date
2019-12-03
Last updated
2020-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

We aim to improve the analgesia women recieve after their caesarean section deliveries at Hutt Hosptial. Expectations of this group are high as they are required to look after a new-born baby, as well as resume their wider family and community responsibilities, whilst at the same time recover from major abdominal surgery. Good analgesia following their caesarean section will aid with this. We are going to trial patient controlled oral analgesia (PCOA) in which women are able to take the pain relief medication themselves from a medication pack which they will recieve after their caesarean delivery and will keep with them during their hospital admission. The medication is the same as what would normally be given after a caesarean section but usually the maternity staff brings the medication to the woman. Providing women the opportunity to be in control of their own oral analgesia ensures the timing of medication administration is not disruptive and provides a period of education in self-administration that can be continued into the community on discharge.

Interventions

Baseline audit performed looking at quality of recovery after caesarean delivery was completed in 2016 over a 2 month period. Intervention will be the introduction of a standardised analgesic regime using patient controlled oral analgesia (PCOA). A repeat audit will then be preformed to ensure non-inferiority. Patient controlled oral analgesia (PCOA) following caesarean section. Women at Hutt hospital who have had a caesearean section and are in a postiion pre-operatively to consent to be in t

Baseline audit performed looking at quality of recovery after caesarean delivery was completed in 2016 over a 2 month period. Intervention will be the introduction of a standardised analgesic regime using patient controlled oral analgesia (PCOA). A repeat audit will then be preformed to ensure non-inferiority. Patient controlled oral analgesia (PCOA) following caesarean section. Women at Hutt hospital who have had a caesearean section and are in a postiion pre-operatively to consent to be in the study may be recruited. If the woman opts into the study they will be given a 7 day medication pack post caesarean section in the post anaesthetic recovery room which they will keep with them during their stay and can take home with them. During their stay the medication pack will be kept in a lockable bag that is bolted to the wall beside their bed. The medication pack contains the same medications normally charted at Hutt hospital for pain relief following caesarean section. They will take the medication themselves from the pack at 4-6 hourly intervals. The medication pack contains: Paracetamol 2 x 500mg oral tablets to take four times a day Ibuprofen 2x 200mg oral tablets to take four times a day Tramadol 1x 50mg oral capsule to take four times a day. They are shown how to identify tramadol in the packs and if when the medication is due to be taken they do not think they need the tramadol they are instructed to take it out of the pack and leave it in the lockable bag. All women who have these packs are also charted additional medications for women following caesarean section on our national drug chart which can be brought to them by the midwife as needed including further analgesia, anti-emetics and anti-puretic. The medication pack will be checked once daily on the pm shift by the maternity staff. Missed doses recorded and discarded. The women can take their medication packs home with them and they will also be given a discharge script for more oral analgesia from the obstetric team looking after the patient. What is prescribed is determined by obstetric team and is not standardised. It usually contains paracetamol, ibuprofen or diclofenac and tramadol. The women are followed in hospital with two visits on the post natal ward and one phone call day 10 post caesarean section. If the woman does not want to participate or are not in a position to consent preoperatively they will recieve their analgesic medication from the maternity staff.

Sponsors

Johanna Pigou
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Women having a caesarean section at Hutt Hospital.

Exclusion criteria

Catagory 1 emergency caesarean section Any emergency caesarean section in which the woman in not in a position to give consent including due to time pressure, pain, feeling overwhelmed Allergy or significant adverse reaction to paracetamol, ibuprofen or tramadol Pre-eclampsia and HELLP syndrome Seizure disorder requiring anti-epileptics Documented history of drug misuse of mother or partner Inability to understand PCOA process for example due to Intellectual/cognitive impairment, Language barriers Risk of serotonin syndrome The woman does not wish to participate

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026