A prospective comparison of early post-operative analgesia in Caesarean Section using bilateral ilio-inguinal block and sub-cutaneous morphine

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000771651

Enrollment

Registered

2005-11-30

Start date

2006-03-01

Completion date

2006-07-01

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

Anaesthesia for Caesarean Section is most often performed by an injection of intra-thecal (spinal) or epidural local anaesthetic. This wears after 2-4 hours after which pain needs to be controlled with other agents. The principal class of drugs used for this analgesia are the opioid drugs (eg. oxycodone, codeine or morphine), all of which cause side effects such as nausea, vomiting, itch and sedation. Bilateral ilio-inguinal blocks (superficial injections on each side of the abdominal wall) have been shown to be effective after general anaesthetic in reducing opioid requirements after Caesarean Section. They are also used routinely for procedures such as inguinal hernia repair. We propose to recruit 120 patients undergoing elective Caesarean Section and randomise them to receive ilio-inguinal blocks with either ropivacaine (a long acting local anaesthetic) or saline (placebo). Those who receive placebo blocks will be given subcutaneous morphine at the end of the procedure (the current standard care). We will review patients at 6 and 24 hours seeking a decrease in pain scores, opioid requirements and opioid side effects.

Interventions

Bilateral ilio-inguinal nerve blocks will be performed at the end of surgery (with 1% ropivicaine (long acting local anaesthetic)), patients will be followed for 24 hours after surgery

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

Those scheduled to undergo elective lower uterine segment Caesarean Section for singleton term pregnancy (>37 weeks gestation). Both multiparous and primparous women will be included.

Exclusion criteria

Inability/unwillingness to give informed consent to participate*Significantly limited English*Height <155cm or >185cm (which may require adjustment of spinal dose)*BMI >35 (which may require adjustment of spinal dose)*Conditions associated with a large uterus (macrosomia, polyhydramnios, multiple pregnancy) or small uterus (intra-uterine growth retardation) which may require adjustment of spinal dose*Classical Caesarean incision*Anticipated complex surgery (eg. multiple previous laparotomies, including >2 previous Caesarean Sections) or additional procedures planned (eg. tubal ligation) which may increase post-operative pain and analgesic requirements*Contra-indication to spinal anaesthesia (such as lack of informed consent, local or generalised infection, coagulopathy, medical or obstetric conditions precluding spinal anaesthesia (eg. significant valvular heart disease, high grade placenta praevia)*Allergy/sensitivity to local anaesthetic, paracetamol, fentanyl, morphine*Allergy/sensitivity to non-steroidal anti-inflammatories (diclofenac), including such conditions as renal impairment, peptic ulcer disease, severe (NSAID-sensitive) asthma*Inability or unwillingness to use a PCA device.

Outcome results