Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612000572864
Ethics application status
Approved
Date submitted
22/05/2012
Date registered
28/05/2012
Date last updated
18/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Does methylnaltrexone reduce the incidence and severity of itch following spinal anaesthesia with intrathecal morphine in women undergoing caesarean delivery.
Scientific title
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?
Secondary ID [1] 280447 0
Nil
Universal Trial Number (UTN)
Trial acronym
The MEAN ITCH Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Incidence and severity of pruritus after intrathecal morphine at caesarean delivery 286421 0
Condition category
Condition code
Anaesthesiology 286673 286673 0 0
Other anaesthesiology
Reproductive Health and Childbirth 286808 286808 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 284806 0
Treatment: Drugs
Intervention code [2] 284914 0
Prevention
Comparator / control treatment
The placebo will be 0.6 ml normal saline for subcutaneous injection into the anaesthetised anterolateral thigh at the completion of surgery.
Control group
Placebo

Outcomes
Primary outcome [1] 287076 0
The severity of intrathecal morphine-induced pruritus among woman delivering by elective caesarean section under spinal anaesthesia, as determined by the mean maximum pruritus score in the first 24 hours after surgery and the 0-24 hour area under the curve for pruritus scores. Pruritus will be scored on a 0-10 verbal numerical rating scale = VNRS
Timepoint [1] 287076 0
Maximum score and area under the curve for pruritus scores over 0-24 hours post-operatively, based on scores at 2, 4, 8 and 24 hours.
Secondary outcome [1] 297327 0
The incidence of intrathecal morphine-induced pruritus in the first 24 hours postoperatively, among women delivering by elective caesarean section under spinal anaesthesia. VNRS score >0.
Timepoint [1] 297327 0
Across 0-24 hours postoperatively; with assessment of early incidence across 0-8 hours
Secondary outcome [2] 297328 0
The incidence of intrathecal morphine-induced pruritus requiring treatment in the first 24 hours postoperatively among women delivering by elective caesarean section under spinal anaesthesia.
Timepoint [2] 297328 0
Across 0-24 hours post-operatively.
Secondary outcome [3] 297329 0
The incidence of nausea and/or vomiting in the first 24 hours after delivery by elective caesarean section under spinal anaesthesia. VNRS>0.
Timepoint [3] 297329 0
0-24 hours post-operatively.
Secondary outcome [4] 297330 0
The incidence of cramping abdominal pain in the first 24 hours after delivery by elective caesarean section under spinal anaesthesia. Presence and severity (VNRS 0-10) of gastrointestinal cramps.
Timepoint [4] 297330 0
0-24 hours post-operatively.
Secondary outcome [5] 297331 0
The OBAS (overall benefit of analgesia score).
Timepoint [5] 297331 0
At 24 hours post-operatively.

Eligibility
Key inclusion criteria
1. American Society of Anesthesiologists classification 1 or 2
2. Elective caesarean section under spinal anaesthesia, with or without epidural catheterization
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Women will be recruited at antenatal pre-admission caesarean section clinics and from the maternal-fetal assessment unit or ward, as appropriate. All must have consented to spinal anaesthesia, including intrathecal morphine for postoperative analgesia. The study intervention will occur post-delivery, at the end of surgery and the study will be completed at 24 hours postoperatively.
Group allocation will occur after delivery, by means of a sealed opaque envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomised, stratified for centre, in a 1:1 ratio by the hospital Pharmacy department using a computer generated random number sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/06/2012
Actual
12/06/2012
Date of last participant enrolment
Anticipated
Actual
25/02/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
130
Accrual to date
Final
137
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5336 0
6008
Recruitment outside Australia
Country [1] 4287 0
Singapore
State/province [1] 4287 0
Singapore
Country [2] 4288 0
United States of America
State/province [2] 4288 0
California

Funding & Sponsors
Funding source category [1] 285208 0
Charities/Societies/Foundations
Name [1] 285208 0
Australian and New Zealand College of Anaesthetists
Country [1] 285208 0
Australia
Primary sponsor type
Hospital
Name
King Edward Memorial Hospital for Women
Address
374 Bagot Road, Subiaco, WA 6008.
Country
Australia
Secondary sponsor category [1] 284080 0
None
Name [1] 284080 0
Address [1] 284080 0
Country [1] 284080 0
Other collaborator category [1] 260817 0
Individual
Name [1] 260817 0
Ban Leong Sng
Address [1] 260817 0
Department of Women's Anaesthesia, KK Women's and Children's Hospital, 100 Bukit Timah Rd, Singapore 229899
Country [1] 260817 0
Singapore
Other collaborator category [2] 260818 0
Individual
Name [2] 260818 0
Brendan Carvalho
Address [2] 260818 0
Department of Anesthesia, Stanford Medical Center, 300 Pasteur Drive, Palo Alto, California 94305
Country [2] 260818 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287210 0
Women and Newborn Health Service
Ethics committee address [1] 287210 0
King Edward Memorial Hospital for Women, GPO Box D184, Perth, WA 6840
Ethics committee country [1] 287210 0
Australia
Date submitted for ethics approval [1] 287210 0
Approval date [1] 287210 0
27/03/2012
Ethics approval number [1] 287210 0
1985/EW

Summary
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.
Trial website
Trial related presentations / publications
M. Paech, B.Sng, L. Ng, E. Nathan, A. Sia and B. Carvalho. Methylnaltrexone to prevent intrathecal morphine-induced pruritus after Caesarean delivery: a multicentre, randomized clinical trial. Br J Anaesth 2015;114(3):469-76
Public notes

Contacts
Principal investigator
Name 34144 0
Prof Michael
Address 34144 0
Department of Anaesthesia and Pain Medicine, King Edward Memorial Hospital for Women, 374 Bagot Road, Subiaco, WA 6008.
Country 34144 0
Australia
Phone 34144 0
+61893402250
Fax 34144 0
+61893402227
Email 34144 0
[email protected]
Contact person for public queries
Name 17391 0
Prof Michael Paech
Address 17391 0
Department of Anaesthesia and Pain Medicine, King Edward Memorial Hospital for Women, 374 Bagot Road, Subiaco, WA 6008.
Country 17391 0
Australia
Phone 17391 0
+61 8 93402222
Fax 17391 0
+61 8 93402227
Email 17391 0
[email protected]
Contact person for scientific queries
Name 8319 0
Prof Michael Paech
Address 8319 0
Department of Anaesthesia and Pain Medicine, King Edward Memorial Hospital for Women, 374 Bagot Road, Subiaco, WA 6008.
Country 8319 0
Australia
Phone 8319 0
+61 8 93402222
Fax 8319 0
+61 8 93402227
Email 8319 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.