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Trial registered on ANZCTR


Registration number
ACTRN12612000530820
Ethics application status
Approved
Date submitted
17/05/2012
Date registered
21/05/2012
Date last updated
21/05/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Ropivacaine wound infusion for postoperative pain control in living donors of liver transplantation
Scientific title
Postoperative pain control in living donors of liver transplantation : A comparison of ropivacaine wound infusion vs. intrathecal morphine with intravenous patient controlled analgesia
Secondary ID [1] 280503 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative pain control 286488 0
Condition category
Condition code
Anaesthesiology 286750 286750 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Local anesthetic (0.5% Ropivacaine) wound instillation device, Painbuster 4ml/hr, for postoperative 72 hours

Painbuster is an elastometric pump with catheters that have multiorifice holes through which local anesthetics can be delivered at a constant rate 4ml/hr if the catheters are placed at the wound are.

As for a rescue analgesics, fentanyl intravenous patient controlled analgeisa (IV PCA) was applied at the end of surgery with a regimen of 1500 ug of fentanyl in normal saline 100 mL (15 ug/mL), programmed for 1ml bolus, 15 minutes lockout time without a basal infusion.
Intervention code [1] 284871 0
Treatment: Devices
Intervention code [2] 284872 0
Treatment: Drugs
Comparator / control treatment
In the comparator group, intrathecal morphine 400ug was administered before induction of anesthesia and fentanyl IV PCA was applied at the end of surgery with a regimen of 1500 ug of fentanyl in normal saline 100 mL (15 ug/mL), programmed for 1ml bolus, 15 minutes lockout time, and 1ml/hr basal rate.
Control group
Active

Outcomes
Primary outcome [1] 287140 0
The Visual analgue scores (VAS) at rest and coughing were assessed to evaluate the intensity of pain
Timepoint [1] 287140 0
At postoperative 4, 8, 12, 24, 48, 72 hours
Secondary outcome [1] 297474 0
A consumption of IV PCA (fentanyl) and supplementary meperidine

An IV PCA device (AutoMed 3200; Acemedical, Korea) that can manifest infused volumes was used to check the amount of IV PCA fentanyl consumption.
Supplementary meperidine was given when appropriate by the VAS >5 even if IV PCA was applied more than 3 time (assessed by the clinician at the ward), and the usage was investigated by reviewing the patient chart by the study time interval. An independent investigator assessed IV PCA fentanyl and meperidine consumption.
Timepoint [1] 297474 0
During postoperative 0-24, 24-48, 48-72 hours
Secondary outcome [2] 297488 0
Side effects were recorded.
respiratory rate, saturation of peripheral oxygen (SpO2), sedation, dizziness, nausea, vomiting, pruritus,
wound complications including hematoma, seroma and wound discharge

Side effects were reviewed with the patients chart and patient inquiery at the study check point

Respiratory rate, saturation of peripheral oxygen (SpO2) were checked with monitoring and recoreded on the patient's chart.
Sedation was assessed on a 5-point scale (1- completely awake with the eyes open; 2 -drowsy; 3 -dozing, 4- mostly sleeping; and 5- not responding).
Dizziness, nausea, vomiting, and pruritus were assessed by asking the patient on a scale of mild, moderate and severe.
Wound complications including hematoma, seroma and wound discharge were inspected by a surgeon on the postoeprative 3 and were recorded on the chart.
Timepoint [2] 297488 0
During postoperative 4,8,24,48,72 hours
Secondary outcome [3] 297499 0
Pulmonary function test (Forced expiratory volume in 1 second, FEV1 and Functional vital capacity, FVC)

a portable spirometry (Micro, Micro Medical Limited, Rochester, U.K.) was used for the assessment
Timepoint [3] 297499 0
-at baseline, at 24, 48, 72 hours postoperatively.

Eligibility
Key inclusion criteria
All living liver donors
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A known allergy to eggs, propofol or any of the drugs used in the study.
Bleeding diathesis, neurologic dysfunction (preexisting lower limb neurological deficit), recent systemic or local infections, insufficient comprehension to use the PCA device, history of drug use, or under treatment with opioids because of chronic pain.

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)
Forty five adults undergoing right hepatectomy are enrolled

Allocation into 2 groups using a computer generated randomization (www.randomizer.org) and sealed opaque envolope technique
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization sequence generation was conducted with computer generated numbers
Masking / blinding
Open (masking not 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
Completed
Date of first participant enrolment
Anticipated
30/11/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
19
Accrual to date
Final
Recruitment outside Australia
Country [1] 4320 0
Korea, Republic Of
State/province [1] 4320 0
Seoul

Funding & Sponsors
Funding source category [1] 285267 0
Self funded/Unfunded
Name [1] 285267 0
Sang Hyun Lee
Country [1] 285267 0
Korea, Republic Of
Primary sponsor type
Individual
Name
Soo Joo Choi
Address
50 Ilwon dong, Kangnam gu, 135-710
Samsung Medical Center
Seoul, Korea
Country
Korea, Republic Of
Secondary sponsor category [1] 284131 0
Individual
Name [1] 284131 0
Sang Hyun Lee
Address [1] 284131 0
50 Ilwon dong, Kangnam gu, 135-710
Samsung Medical Center
Seoul, Korea
Country [1] 284131 0
Korea, Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287283 0
Samsung Medical Center
Ethics committee address [1] 287283 0
50 Ilwon dong, Kangnam gu, 135-710
Samsung Medical Center
Seoul, Korea
Ethics committee country [1] 287283 0
Korea, Republic Of
Date submitted for ethics approval [1] 287283 0
24/09/2010
Approval date [1] 287283 0
11/10/2010
Ethics approval number [1] 287283 0

Summary
Brief summary
We evaluated the efficacy and safety of ropivacaine continuous infusion (Painbuster) in liver donors compared to intrathecal morphine (ITM) with intravenous patient controlled analgesia (IV PCA).
Adult donors were randomly allocated into 2 groups: ITM + IV PCA group, Painbuster + rescue IV PCA group. Donors in Painbuster + rescue IV PCA group were placed a catheter in the wound and 0.5% ropivacaine was infused for postoperative 72 hours at a rate of 4ml/hr. Donors in ITM + IV PCA group received morphine sulfate (400ug) and fentanyl IV PCA postoperatively . The visual analogue scale (VAS) at rest and coughing, and IV PCA fentanyl and meperidine consumptions were assessed for 72 hours postoperatively. Side effects including sedation, dizziness, nausea, vomiting, pruritis, respiratory depression, wound seroma or hematoma, and bowel recovery time were recorded.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34187 0
Address 34187 0
Country 34187 0
Phone 34187 0
Fax 34187 0
Email 34187 0
Contact person for public queries
Name 17434 0
Sang Hyun Lee
Address 17434 0
50 Ilwon dong, Kangnam gu, 135-710
Samsung Medical Center
Seoul, Korea
Country 17434 0
Korea, Republic Of
Phone 17434 0
+82-2-3410-2470
Fax 17434 0
Email 17434 0
[email protected]
Contact person for scientific queries
Name 8362 0
Sang Hyun Lee
Address 8362 0
50 Ilwon dong, Kangnam gu, 135-710
Samsung Medical Center
Seoul, Korea
Country 8362 0
Korea, Republic Of
Phone 8362 0
+82-2-3410-2470
Fax 8362 0
Email 8362 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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