Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000241639
Ethics application status
Approved
Date submitted
29/08/2005
Date registered
31/08/2005
Date last updated
31/08/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
The WIPPET Study
Scientific title
The effect of levobupivicaine Wound Infusion, for 24 hours, on Postoperative Pain after caEsarean secTion - a prospective, randomised, double-blind parallel-group placebo controlled clinical trial.
Universal Trial Number (UTN)
Trial acronym
WIPPET
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative analgesia after caesarean section 327 0
Condition category
Condition code
Surgery 376 376 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To determine whether levobupivicaine, administered by wound infiltration and continuous infusion into the rectus sheath (using Go Medical Balloon Infusor Catheter) is effective in reducing postoperative opioid requirements.
Intervention code [1] 283 0
Treatment: Drugs
Comparator / control treatment
Parallel group will receive saline instead of levobupivicaine.
Control group
Placebo

Outcomes
Primary outcome [1] 435 0
Efficacy of pain relief as assessed by pain score (visual analogue scale - VAS)
Timepoint [1] 435 0
During movement and at 6 and 24 hours.
Secondary outcome [1] 951 0
Cumulative postoperative morphine dose requirement.
Timepoint [1] 951 0
To 6 and 24 hours.
Secondary outcome [2] 952 0
Pain scores at rest and on movement
Timepoint [2] 952 0
At 2, 6, 24 and 48 hours postoperatively.
Secondary outcome [3] 953 0
Global assessment of pain
Timepoint [3] 953 0
From end of surgery until 24 hours (nil; mild; moderate; severe).
Secondary outcome [4] 954 0
Incidence and severity of side effects
Timepoint [4] 954 0
0-10 numerical rating score or ordinal scales for postoperative nausea and vomiting, sedation, pruritus.
Secondary outcome [5] 955 0
Presence of symptoms associated with premonitory central nervous system local anaesthetic toxicity.
Timepoint [5] 955 0
Secondary outcome [6] 956 0
Time to first ambulation.
Timepoint [6] 956 0
Secondary outcome [7] 957 0
Time to first oral food intake.
Timepoint [7] 957 0
Secondary outcome [8] 958 0
Satisfaction with pain relief (0-100 VAS).
Timepoint [8] 958 0
Secondary outcome [9] 959 0
Wound healing
Timepoint [9] 959 0
Incidence of wound dehiscence or infection on day 4 postoperatively and at 30 days as assessed by a telephone call to the patient to determine presence of wound edge separation since discharge.
Secondary outcome [10] 960 0
Venous levobupivicaine concentrations
Timepoint [10] 960 0
At baseline and at set time intervals after wound infiltration and during continuous wound irrigation for a 21 hour postoperative period and until 4 hours after cesstion of the infusion (for 20 patients in study only).

Eligibility
Key inclusion criteria
ASA 1 or 2. Elective caesarean section with pfannensteil incision. Consent for spinal anesthesia and postoperative patient controlled intravenous morphine analgesia (PCIA).
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of allergy to amide local anaesthetic or morphine.Current opioid use excluding codeine.Patients unsuitable for PCIA system.Anaesthesia other than spinal anaesthesia.Surgical incision other than pfannensteil.Surgery other than caesarean section (inlcuding tubal ligation).Requirement for administration of local anaesthetic at other sites during the procedure. Surgical decision to insert a wound drainage catheter.

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)
Infiltration solutions to be prepared by anaesthetist not involved in study. Solutions coded to maintain blinding of patient and observers. Allocation using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated sequence
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
Not yet recruiting
Date of first participant enrolment
Anticipated
9/02/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
76
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 432 0
Commercial sector/Industry
Name [1] 432 0
Abbott Australasia
Country [1] 432 0
Australia
Primary sponsor type
Individual
Name
Dr Sharon Smedley
Address
Country
Secondary sponsor category [1] 350 0
Individual
Name [1] 350 0
Professor Michael Paech
Address [1] 350 0
King Edward Memorial Hospital for Women
374 Bagot Road
Subiaco
Perth WA 6008
Country [1] 350 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1401 0
King Edward Memorial Hospital for Women
Ethics committee address [1] 1401 0
374 Bagot Road, Subiaco, Perth, WA, 6008
Ethics committee country [1] 1401 0
Australia
Date submitted for ethics approval [1] 1401 0
Approval date [1] 1401 0
Ethics approval number [1] 1401 0

Summary
Brief summary
The aim of this study is to determine whether infiltration and then continuous infusion of the wound with local anaesthetic reduces pain after caesarean section. Secondary outcomes include the effect on the need for opioid pain killers (e.g. morphine) and recovery after caesarean section. Currently the common methods used for post-caesarean pain relief include opioid pain killers (intravenous and oral), non-steroidal anti-inflammatory drugs, paracetamol and epidural analgesia. Opioids have unwanted side effects such as drowsiness, nausea and vomiting, itchiness and constipation, and pass to the newborn in breast milk. Epidural analgesia requires an indwelling epidural catheter and has infection risks, as well as being labour intensive. Numerous studies have looked at the effectiveness of local anaesthetics administered by infiltration and/or infusion as a means of postoperative analgesia after abdominal surgery. Several demonstrated a clear benefit to this approach, while others found no advantage. Two studies of wound infusion following caesarean delivery showed a reduced need for opioid painkillers but the new local anaesthetic levobupivicaine has not yet been studied for wound infusion. Recently, two wound infusion catheters have been developed to aid local anaesthetic infusion to surgical wounds. Information on absorption of local anaesthetics into the blood after wound infiltration is limited. Bupivicaine is the most widely used local anaesthetic. A study determined venous bupivicaine levels follwing total abdominal field block but this regimen did not inlcude continuous infusion. The effects of repeated ropivacaine instillation into the wound has been assessed and unbound ropivacaine concentrations were below the toxic range, however accumulation was noted. An alternative to bupivucaine and ropivicaine is levobupivicaine which has a better side effect profile than bupivicaine. There is no information about its absortion after wound instillation. A second aim of this study would be to determine venous levobupivicaine concentraions resulting from wound infiltration and a 24 hour postoperative period of irrigation by infusing through a wound catheter.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35989 0
Address 35989 0
Country 35989 0
Phone 35989 0
Fax 35989 0
Email 35989 0
Contact person for public queries
Name 9472 0
Professor Michael Paech or Research Nurses, Desiree Cavill & Tracy Bingham
Address 9472 0
King Edward Memorial Hospital for Women
374 Bagot Road
Subiaco Perth WA 6008
Country 9472 0
Australia
Phone 9472 0
+61 8 93402222 Pager 3223 (Mike Paech) or 3433 (Research Nurses)
Fax 9472 0
+61 8 93402260
Email 9472 0
Michael.Paech@health.wa.gov.au
Contact person for scientific queries
Name 400 0
Professor Michael Paech
Address 400 0
King Edward Memorial Hospital for Women
374 Bagot Road
Subiaco Perth WA 6008
Country 400 0
Australia
Phone 400 0
+61 8 93402222 Pager 3223
Fax 400 0
+61 8 93402260
Email 400 0
Michael.Paech@health.wa.gov.au

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No Supporting Document Provided



Results publications and other study-related documents

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