Does methylnaltrexone reduce the incidence and severity of itch following spinal anaesthesia with intrathecal morphine in women undergoing caesarean delivery.

In women receiving spinal anaesthesia including intrathecal morphine for caesarean section, is subcutaneous methylnaltrexone 12 mg given at the end of surgery more effective than placebo in reducing 24 hour pruritus severity?

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000572864

Acronym

The MEAN ITCH Trial

Enrollment

137

Registered

2012-05-28

Start date

2012-06-12

Completion date

2013-02-25

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 randomised clinical trial is investigating the preventive effect of subcutaneous methylnaltrexone, in comparison with placebo, on the severity of pruritus in women receiving spinal anaesthesia including intrathecal morphine for caesarean section.

Interventions

The study drug will be 12 mg methylnaltrexone (MNTX) in 0.6 ml solution for subcutaneous injection into the anaesthetised anterolateral thigh at the completion of surgery.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. American Society of Anesthesiologists classification 1 or 2 2. Elective caesarean section under spinal anaesthesia, with or without epidural catheterization

Exclusion criteria

1. Preoperative use of opioid medication 2. Contraindication to spinal anaesthesia 3. Preoperative pruritus for any reason 4. Weight outside the range 62-114 kg 5. Severe renal impairment, gastro-intestinal disease or diarrhoea 6. Conversion to another method of anaesthesia, prior to study drug, for any reason 7. Failure to administer intrathecal morphine 8. Administration of a drug with anti-pruritic activity (propofol, antihistamine, 5HT3-receptor antagonists or other drugs with opioid agonist or antagonist activity such as tramadol or naloxone) prior to study drug 9. Administration of epidural opioid prior to administration of study drug.

Outcome results