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Trial registered on ANZCTR


Registration number
ACTRN12605000771651
Ethics application status
Approved
Date submitted
29/11/2005
Date registered
30/11/2005
Date last updated
26/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A prospective comparison of early post-operative analgesia in Caesarean Section using bilateral ilio-inguinal block and sub-cutaneous morphine
Scientific title
A prospective comparison of early post-operative analgesia in Caesarean Section using bilateral ilio-inguinal block and sub-cutaneous morphine
Secondary ID [1] 288003 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Caesarean Section 927 0
Condition category
Condition code
Reproductive Health and Childbirth 995 995 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 775 0
Treatment: Drugs
Comparator / control treatment
Bilateral ilio-inguinal nerve blocks will be performed at the end of surgery (with saline (placebo)), patients will be followed for 24 hours after surgery
Control group
Active

Outcomes
Primary outcome [1] 1325 0
Analgesia: Morphine use
Timepoint [1] 1325 0
At 6 and 24 hours
Primary outcome [2] 1326 0
Analgesia: time to first anlgesia
Timepoint [2] 1326 0
The second primary outcome is "time to first analgesia request", therefore the time point is the outcome
Primary outcome [3] 1327 0
Analgesia: VAS scores of pain
Timepoint [3] 1327 0
VAS scores will be taken at 6 and 24 hours
Secondary outcome [1] 2368 0
Presence and severity of opiod side effects (nausea, vomiting, itch, sedation).
Timepoint [1] 2368 0
In first 24 hrs.

Eligibility
Key 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.
Minimum age
Not stated
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
numbered envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated random number table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/02/2006
Actual
1/03/2006
Date of last participant enrolment
Anticipated
Actual
1/07/2006
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1093 0
Hospital
Name [1] 1093 0
Royal Women's Hospital
Country [1] 1093 0
Australia
Primary sponsor type
Hospital
Name
Royal Women's Hospital
Address
Flemington Rd, Parkville Vic 3052
Country
Australia
Secondary sponsor category [1] 953 0
None
Name [1] 953 0
Nil
Address [1] 953 0
Country [1] 953 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293925 0
Royal Women's Hospital
Ethics committee address [1] 293925 0
Grattan St
PARKVILLE Vic 3052
Ethics committee country [1] 293925 0
Australia
Date submitted for ethics approval [1] 293925 0
01/02/2006
Approval date [1] 293925 0
01/02/2006
Ethics approval number [1] 293925 0
n/a

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35574 0
Dr James Griffiths
Address 35574 0
Royal Women's Hospital
Grattan St
Parkville, Vic 3052
Country 35574 0
Australia
Phone 35574 0
+61418306793
Fax 35574 0
Email 35574 0
[email protected]
Contact person for public queries
Name 9964 0
Dr Dr Phil Popham
Address 9964 0
Department of Anaesthesia
Royal Women's Hospital
Carlton VIC 3052
Country 9964 0
Australia
Phone 9964 0
+61 3 93442000
Fax 9964 0
Email 9964 0
[email protected]
Contact person for scientific queries
Name 892 0
Dr Dr James Griffiths
Address 892 0
PO Box 2002
Ivanhoe East VIC 3079
Country 892 0
Australia
Phone 892 0
+61 418306793
Fax 892 0
Email 892 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.