Skip to content

Nurse Practitioner led Pain Management the day after Caesarean Section: A Randomised Controlled Trial

A Randomised Controlled Trial comparing a personalised pain intervention with immediate release oxycodone to controlled release oxycodone the day after Caesarean Section

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000076774
Enrollment
122
Registered
2013-01-21
Start date
2013-06-28
Completion date
2014-11-28
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Objectives: This randomised controlled trial (n = 122) compared the effectiveness of a nurse practitioner (NP) pain management intervention commencing with immediate release oxycodone the day after caesarean section compared to standard care with a prescription of controlled release oxycodone. Methods: A pain management plan based on immediate release oxycodone was developed for each woman in the intervention group. The NP addressed psychosocial aspects of pain in order to (1) reduce pain intensity, (2) decrease pain interference on maternal function and recovery, and (3) increase maternal control over pain management. The control group received standard care including controlled-release oxycodone prescribed twice daily for two days.

Interventions

For the analgesic component of the intervention, participants were prescribed scheduled IR oxycodone doses at 8:00 (10mg), 14:00 (5mg) and 20:00 hours (5mg), commencing the day after CS. Prior to the first dose, the NP allowed participants to discuss their caesarean experience, beliefs about pain and their expectations for pain management. The intervention included discussing concerns regarding analgesics as well as fears about pain when getting up to look after their baby. Any misconceptions we

For the analgesic component of the intervention, participants were prescribed scheduled IR oxycodone doses at 8:00 (10mg), 14:00 (5mg) and 20:00 hours (5mg), commencing the day after CS. Prior to the first dose, the NP allowed participants to discuss their caesarean experience, beliefs about pain and their expectations for pain management. The intervention included discussing concerns regarding analgesics as well as fears about pain when getting up to look after their baby. Any misconceptions were discussed and the proposed pain management plan was explained to each participant. This focused on how IR oxycodone could lessen pain interference on sitting up, mobilising and caring for a newborn. The NP explained that it would take one hour for a dose of IR oxycodone to reach peak analgesic effect, thereby reducing pain when increased pain was anticipated. The NP also explained that additional IR oxycodone or IR tramadol were available on request and that the IR doses only had an analgesic effect for a few hours. Maternal right to refuse any scheduled dose of oxycodone was reinforced in order to transfer decision-making power to participants. Reviews at 11:00 and 14:00 evaluated how participants perceived their progress in terms of pain intensity and function. If analgesia was inadequate, options for pain management were discussed, including commencing 10mg of CR oxycodone at 20:00 hours in place of the scheduled 5mg IR oxycodone dose. Both groups received equal doses of regular oxycodone on the first postoperative day but the groups differed in the formulation used. The control group received controlled-release (CR) oxycodone as the regular dose, whereas the intervention group received regular Immediate-release (IR) oxycodone. Both groups received equal opportunity for changes to their pain management plan.

Sponsors

IPSWICH HOSPITAL
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

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

Inclusion criteria

Public patients over 18 years of age English speaking (to reduce data collection error and costs) Scheduled for elective caesarean section the day prior to the intervention.

Exclusion criteria

Chronic pain, opioid tolerance, history of substance abuse, allergies to agents used in the research or epilepsy or use of serotonin re-uptake inhibitors, obstructive sleep apnoea.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026