TerminatedPhase 4ACTRN12605000771651

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

Sponsor

Royal Women's Hospital

Enrollment

120 participants

Start Date

Mar 1, 2006

Study Type

Interventional

Conditions

Caesarean Section

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.

Eligibility

Sex: Females

Inclusion Criteria1

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 Criteria1

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.

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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