Skip to content

Oral analgesia compared with intrathecal morphine for pain after caesarean delivery: a randomised controlled trial

Oral oxycodone analgesia compared with intrathecal morphine for pain relief after caesarean delivery: a randomised controlled trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12606000506594
Acronym
The SMOOTH study
Enrollment
120
Registered
2006-12-07
Start date
2007-01-21
Completion date
Unknown
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

This study will investigate two methods of pain relief after caesarean section conducted under regional anaesthesia. Our hypothesis is that multimodal analgesia including intrathecal morphine is more effective than multimodal analgesia with regular administration of oral opioid.

Interventions

Intervention group: Intrathecal morphine 100 mcg given with spinal anaesthesia immediately preoperatively. Both control group and intervention groups also receiving oral paracetamol 1 g in recovery and 6 hourly until 24 hours postoperatively plus diclofenac 100 mg per rectum at completion of surgery and diclofenac 50 mg

Intervention group: Intrathecal morphine 100 mcg given with spinal anaesthesia immediately preoperatively. Both control group and intervention groups also receiving oral paracetamol 1 g in recovery and 6 hourly until 24 hours postoperatively plus diclofenac 100 mg per rectum at completion of surgery and diclofenac 50 mg orally 8 hourly until 24 hours postoperatively, after caesarean section.

Sponsors

Individual (Michael Paech)
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)

Eligibility

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

Inclusion criteria

Elective or non-elective caesarean section under combined spinal-epidural or spinal anaesthesia American Society of Anesthesiologists classification 1 or 2

Exclusion criteria

Preoperative opioid useContraindication, allergy or known intolerance to study drugsPreoperative nausea or pruritusFailure to identify the subarachnoid space or accidental dural puncture with the epidural needleRequirement for intraoperative opioid or epidural analgesic other than local anaesthetic Conversion to general anaesthesia.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026