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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of continuous preperitoneal infusion of ropivacaine in laparoscopic colorectal surgery
Scientific title
Efficacy of postoperative continuous preperitoneal infusion of 0.5% ropivacaine at 4ml/hr after laparoscopic colorectal surgery compared to intravenous patient controlled postoperative analgesia
Secondary ID [1] 253610 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
This study investigates postoperative analgesic efficacy and recovery in patients receiving continuous preperitoneal ropivacaine infusion vs. intravenous patient controlled analgesia after laparoscopic colorectal surgery. 261170 0
Condition category
Condition code
Anaesthesiology 259324 259324 0 0
Pain management
Oral and Gastrointestinal 259327 259327 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Study type
Description of intervention(s) / exposure
Intervention consists preperitoneal placement of catheter with multiple side-holes to continuously release 0.5%ropivacaine at 4ml/hr for postoperative 72hours. This placement will be conducted by an experienced attending surgeon.

Intervention with 0.5% ropivacaine (local anesthetics) continuous infusion at 4ml/hr
Intervention code [1] 258032 0
Treatment: Drugs
Intervention code [2] 258046 0
Treatment: Devices
Comparator / control treatment
Control : IV PCA regimen includes fentanyl 16 mcg/ml in 100ml saline bag with basal infusion rate of 0.5 ml/hr, bolus of 1ml at 15min lockout interval. Thus maximum dose allowed per hour is 80mcg and basal infusion is continued with bolus injection when patient presses a button. Overall duration of this method is 72 hours postoperatively.
Control group

Primary outcome [1] 262127 0
Decrease in Visual analogue scale (VAS)
Timepoint [1] 262127 0
postoperative 2hr, 6hr, 24hr, 48hr, 72hr
Secondary outcome [1] 273208 0
return of bowel movement (flatus)
Timepoint [1] 273208 0
exact time checking during postoeprative period
Secondary outcome [2] 273209 0
reduced consumption of rescue analgesics
Timepoint [2] 273209 0
postoeprative 2hr, 6hr, 24hr, 48hr, 72hr

Key inclusion criteria
ASA PS 2-3 patients undertaking laparoscopic colorectal surgery
Minimum age
20 Years
Maximum age
65 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
patients with previous opioid analgesic medication
allergic to local anesthetics or opioid
coagulopathy or hemostatic abnormalities
neurologic disorder / mental disorder
obesity BMI > 30

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients are randomly allocated to one of two groups by using computer based randomized number concealed in an envelop before intervention. All patients receive preperitoneal wound catheterization and IV PCA (intravenous patient controlled analgesia ) device, but one group with study drug only in preperitoneal catheter and the other group with study drug only in IV PCA. Allocation is blinded both to patients and investigators.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Consecutive patients receiving laparoscopic colorectal surgery will be enrolled with randomization sequence generation using computerized randomizer.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 3199 0
Korea, Republic Of
State/province [1] 3199 0

Funding & Sponsors
Funding source category [1] 258506 0
Name [1] 258506 0
Samsung Medical Center
Address [1] 258506 0
50 Ilwon dong, Gangnam gu, 135-710
Samsung Seoul Hospital
Country [1] 258506 0
Korea, Republic Of
Primary sponsor type
Samsung Medical Center
50 Ilwon dong, Gangnam gu, 135-710
Samsung Seoul Hospital
Korea, Republic Of
Secondary sponsor category [1] 263756 0
Commercial sector/Industry
Name [1] 263756 0
B. Braun Korea Co., Ltd.
Address [1] 263756 0
13th Fl., West Wing, POSCO Center Bldg. 892, Daechi4-Dong, Kangnam-Ku, Seoul 135-777
Country [1] 263756 0
Korea, Republic Of

Ethics approval
Ethics application status
Ethics committee name [1] 260480 0
Samsung Medical Center IRB
Ethics committee address [1] 260480 0
50 Ilwon dong, Gangnam gu, 135-710
Samsung Seoul Hospital
Ethics committee country [1] 260480 0
Korea, Republic Of
Date submitted for ethics approval [1] 260480 0
Approval date [1] 260480 0
Ethics approval number [1] 260480 0

Brief summary
This controlled double blinded randomized clinical study intend to investigate postoperative analgesia and bowel recovery thus overall recovery efficacy of continuous preperitoenal infusion of 0.5% ropivacaine compared to intravenous opioid based patient controlled postoeprative analgesia. The main hypothesis of this study is that analgesic method using local anesthetic will provide equivalent or better analgesia with prompt bowel recovery.
Trial website
Trial related presentations / publications
under manuscript preparation
Public notes

Principal investigator
Name 32217 0
Prof Woo Seog Sim
Address 32217 0
50 Ilwon dong, Gangnam gu, 135-710 Samsung Seoul Hospital
Country 32217 0
Korea, Republic Of
Phone 32217 0
Fax 32217 0
Email 32217 0
Contact person for public queries
Name 15464 0
Dr Sang Hyun Lee
Address 15464 0
50 Ilwon dong, Gangnam gu, 135-710
Samsung Seoul Hospital
Country 15464 0
Korea, Republic Of
Phone 15464 0
Fax 15464 0
Email 15464 0
Contact person for scientific queries
Name 6392 0
Prof Woo Seog Sim
Address 6392 0
50 Ilwon dong, Gangnam gu, 135-710
Samsung Seoul Hospital
Country 6392 0
Korea, Republic Of
Phone 6392 0
Fax 6392 0
Email 6392 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary