ANZCTR - Registration

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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

Condition category

Condition code

Surgery

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]

Treatment: Drugs

Comparator / control treatment

Parallel group will receive saline instead of levobupivicaine.

Control group

Placebo

Outcomes

Primary outcome [1]

Efficacy of pain relief as assessed by pain score (visual analogue scale - VAS)

Timepoint [1]

During movement and at 6 and 24 hours.

Secondary outcome [1]

Cumulative postoperative morphine dose requirement.

Timepoint [1]

To 6 and 24 hours.

Secondary outcome [2]

Pain scores at rest and on movement

Timepoint [2]

At 2, 6, 24 and 48 hours postoperatively.

Secondary outcome [3]

Global assessment of pain

Timepoint [3]

From end of surgery until 24 hours (nil; mild; moderate; severe).

Secondary outcome [4]

Incidence and severity of side effects

Timepoint [4]

0-10 numerical rating score or ordinal scales for postoperative nausea and vomiting, sedation, pruritus.

Secondary outcome [5]

Presence of symptoms associated with premonitory central nervous system local anaesthetic toxicity.

Timepoint [5]

Secondary outcome [6]

Time to first ambulation.

Timepoint [6]

Secondary outcome [7]

Time to first oral food intake.

Timepoint [7]

Secondary outcome [8]

Satisfaction with pain relief (0-100 VAS).

Timepoint [8]

Secondary outcome [9]

Wound healing

Timepoint [9]

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]

Venous levobupivicaine concentrations

Timepoint [10]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Abbott Australasia

Address [1]

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Sharon Smedley

Address

Country

Secondary sponsor category [1]

Individual

Name [1]

Professor Michael Paech

Address [1]

King Edward Memorial Hospital for Women
374 Bagot Road
Subiaco
Perth WA 6008

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

King Edward Memorial Hospital for Women

Ethics committee address [1]

374 Bagot Road, Subiaco, Perth, WA, 6008

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Professor Michael Paech or Research Nurses, Desiree Cavill & Tracy Bingham

Address

King Edward Memorial Hospital for Women
374 Bagot Road
Subiaco Perth WA 6008

Country

Australia

Phone

+61 8 93402222 Pager 3223 (Mike Paech) or 3433 (Research Nurses)

Fax

+61 8 93402260

Michael.Paech@health.wa.gov.au

Contact person for scientific queries

Name

Professor Michael Paech

Address

King Edward Memorial Hospital for Women
374 Bagot Road
Subiaco Perth WA 6008

Country

Australia

Phone

+61 8 93402222 Pager 3223

Fax

+61 8 93402260

Michael.Paech@health.wa.gov.au

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

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No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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