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
ACTRN12614000587606
Ethics application status
Approved
Date submitted
7/05/2014
Date registered
3/06/2014
Date last updated
9/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Plasma ropivacaine concentrations and duration of sensory block after ultrasound-guided transversus abdominis plane block, with and without additives (adrenaline and clonidine), for gynaecological surgery
Scientific title
Plasma ropivacaine levels and duration of sensory block in women undergoing gynaecological surgery and having ultrasound-guided transversus abdominis blocks with ropivacaine and additives (clonidine and adrenaline) vs ropivacaine alone
Secondary ID [1] 284559 0
nil
Universal Trial Number (UTN)
U1111-1156-5247
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post operative pain 291826 0
Condition category
Condition code
Anaesthesiology 292191 292191 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ultrasound-guided transversus abdominis plane blocks using either:
- Ropivacaine 3mg/kg with 1:400,000 adrenaline
- Ropivacaine 3mg/kg with clonidine 2mcg/kg
- Ropivacaine 3mg/kg plus clonidine 2mcg/kg subcutaneous
Intervention code [1] 289331 0
Treatment: Drugs
Comparator / control treatment
Transversus abdominis plane blocks using:
- Ropivacaine 3mg/kg
Control group
Active

Outcomes
Primary outcome [1] 292066 0
Plasma ropivacaine levels as measured by Gas Chromatograph Mass Spectrometry following transversus abdominis plane block
Timepoint [1] 292066 0
Time points following transversus abdominis plane block: every 10 minutes for the first hour, then every 30 minutes until 3 hours post block, and then at 6, 9, and 12 hours post block
Secondary outcome [1] 308121 0
Sensory testing (warm, cold, and Von Frey Filament testing)
Timepoint [1] 308121 0
3, 6, 9, and 12 hours post block

Eligibility
Key inclusion criteria
Adult female patients, aged 18 to 65, undergoing elective gynaecological surgery and who are planned to receive TAP blocks
Minimum age
18 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Allergy to any of the drugs in the study, morbid obesity, infection at site of block placement, pre-existing neurological or muscular disease, coagulopathy, significant liver or renal disease, and pregnancy.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generator called "Research Randomizer"
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis
The total sample size will be 80, with 20 patients allocated to each trial group. This is effectively a pilot study since there are no studies available that specifically measure blood levels after ropivacaine TAP block with and without clonidine in the literature on which to base a sample size calculation. However, using the data from the recent study measuring ropivacaine levels in the blood with and without adrenaline (control mean peak level = 2.11mcg/ml +/- 0.31; mean reduction with adrenaline of 13%), we calculate (assuming an estimated effect of clonidine to be 2/3 of that of adrenaline, and with alpha=0.05 and power=0.8), that 17 patients per group will be required. To allow for potential drop-outs, we will recruit 20 patients per group.

The data will be summarised using appropriate measures of central tendency and tested for normality of distribution. For parametric data, t-tests and ANOVA will be used. For non-parametric data, Mann-Whitney U tests or Kruskall-Wallis tests will be used as appropriate.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/06/2014
Actual
16/06/2014
Date of last participant enrolment
Anticipated
30/05/2016
Actual
30/11/2015
Date of last data collection
Anticipated
Actual
30/11/2015
Sample size
Target
80
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2432 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 8059 0
2050 - Missenden Road

Funding & Sponsors
Funding source category [1] 289187 0
Hospital
Name [1] 289187 0
Department of Anaesthetics,
Royal Prince Alfred Hospital
Country [1] 289187 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital, Sydney Local Health District
Address
Missenden Road,
Camperdown,
2050
NSW
Country
Australia
Secondary sponsor category [1] 287858 0
None
Name [1] 287858 0
Address [1] 287858 0
Country [1] 287858 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290966 0
SLHD Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 290966 0
Research Development Office, RPAH
Missenden Rd, Camperdown, NSW
2050
Ethics committee country [1] 290966 0
Australia
Date submitted for ethics approval [1] 290966 0
Approval date [1] 290966 0
11/04/2014
Ethics approval number [1] 290966 0
HREC/14/RPAH/10

Summary
Brief summary
The purpose of this study is to assess how clonidine as an additive to local anaesthetics works when used for abdominal wall pain blocks (transversus abdominis plane blocks) after gynaecological surgery. One hypothesis is that it causes blood vessel constriction and slows the washout of local anaesthetic into the blood stream, therefore leaving it at its site of action for longer. We will assess this by measuring the levels of local anaesthetic in the blood over time. Simultaneously, we will assess the abdominal wall sensation to determine if and by how long clonidine improves the duration of postoperative pain relief in these patients.
Trial website
Trial related presentations / publications
none
Public notes

Contacts
Principal investigator
Name 48174 0
Dr Jennifer Crawford
Address 48174 0
Royal Prince Alfred Hospital
Department of Anaesthetics
Missenden Rd, Camperdown
2050
NSW
Country 48174 0
Australia
Phone 48174 0
+61 2 95158564
Fax 48174 0
Email 48174 0
[email protected]
Contact person for public queries
Name 48175 0
Dr Jennifer Crawford
Address 48175 0
Royal Prince Alfred Hospital
Department of Anaesthetics
Missenden Rd, Camperdown
2050
NSW
Country 48175 0
Australia
Phone 48175 0
+61 2 95158564
Fax 48175 0
Email 48175 0
[email protected]
Contact person for scientific queries
Name 48176 0
Dr Jennifer Crawford
Address 48176 0
Royal Prince Alfred Hospital
Department of Anaesthetics
Missenden Rd, Camperdown
2050
NSW
Country 48176 0
Australia
Phone 48176 0
+61 2 95158564
Fax 48176 0
Email 48176 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.