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Trial registered on ANZCTR


Registration number
ACTRN12610000910000
Ethics application status
Approved
Date submitted
25/10/2010
Date registered
26/10/2010
Date last updated
26/10/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Are the intraperitoneal ropivacaine instillation and ropivacaine infiltration at the port site effective in relieving the postoperative pain after laparoscopic cholecystectomy?
Scientific title
In patients undergoing laparoscopic cholecystectomy, are intraperitoneal ropivacaine instillation and ropivacaine infiltration at the port site effective in terms of visceral pain, parietal pain, and shoulder tip pain?
Secondary ID [1] 252946 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pain following laparoscopic cholecystectomy 258478 0
Condition category
Condition code
Anaesthesiology 258643 258643 0 0
Pain management
Oral and Gastrointestinal 258644 258644 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Surgery 258645 258645 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
arm 1:both infiltration at the port site and intraperitoneal instillation: 20ml of a solution containing ropivacaine (2 mg/ml) was infiltrated at the port site before insertion of trocar and 100 ml of ropivacaine solution (2 mg/kg) was infused intraperitoneally immediately after the creation of the pneumoperitoneum and 10 min before the beginning of surgery..
arm 2: intraperitoneal instillation: 20ml normal saline was infiltrated at the port site before insertion of trocar, and 100 ml of ropivacaine solution (2 mg/kg) was infused intraperitoneally immediately after the creation of the pneumoperitoneum and 10 min before the beginning of surgery..
arm 3: infiltration at the port site:20ml of a solution containing ropivacaine (2 mg/ml) was infiltrated at the port site before insertion of trocar and 100 ml of normal saline solution was infused intraperitoneally immediately after the creation of the pneumoperitoneum and 10 min before the beginning of surgery..
Intervention code [1] 257474 0
Treatment: Drugs
Comparator / control treatment
Control group: 20ml normal saline was infiltrated at the port site before insertion of trocar received 100 ml of normal saline solution was infused intraperitoneally immediately after the creation of the pneumoperitoneum and 10 min before the beginning of surgery.
Control group
Placebo

Outcomes
Primary outcome [1] 259488 0
Visceral Pain score assessed using visual analogue scale
Timepoint [1] 259488 0
at 2hr, 4hr, 8hr, 12hr, 24hr postoperatively
Primary outcome [2] 259489 0
Parietal Pain score assessed using visual analogue scale
Timepoint [2] 259489 0
at 2hr, 4hr, 8hr, 12hr, 24hr postoperatively
Primary outcome [3] 259490 0
Shoulder tip Pain score assessed using visual analogue scale
Timepoint [3] 259490 0
at 2hr, 4hr, 8hr, 12hr, 24hr postoperatively
Secondary outcome [1] 266075 0
Frequency to push the button of patient controlled analgesia machine recordedy computerized patient controlled analgesia machine
Timepoint [1] 266075 0
at 2hr, 4hr, 8hr, 12hr, 24hr postoperatively
Secondary outcome [2] 266076 0
fentanyl consumption recorded by nurse
Timepoint [2] 266076 0
at 2hr, 4hr, 8hr, 12hr, 24hr postoperatively

Eligibility
Key inclusion criteria
patients undergoin laparscopic cholecystectomy
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
body weight lower than 45 kg or greater than 100 kg, history of severe underlying cardiovascular, pulmonary, renal or hepatic disease, or allergy to local anaesthetics

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)
The details of the series are kept in a set of sealed envelopes, each bearing only the case number on the outside. After admitting into the operating room and just before the induction of anaesthesia, the numbered envelope was opened and the card inside determined which group the patient would be affiliated to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization into one of the four groups was based on Excel random-number generation.
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
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 2990 0
Korea, Republic Of
State/province [1] 2990 0

Funding & Sponsors
Funding source category [1] 257926 0
University
Name [1] 257926 0
Chung-Ang University
Address [1] 257926 0
224-1 Heukseok-dong, Dongjak-gu Seoul, 156-755
Country [1] 257926 0
Korea, Republic Of
Primary sponsor type
University
Name
Chung-Ang University
Address
224-1 Heukseok-dong, Dongjak-gu Seoul, 156-755
Country
Korea, Republic Of
Secondary sponsor category [1] 257117 0
None
Name [1] 257117 0
Address [1] 257117 0
Country [1] 257117 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259938 0
Institutional Board of Chung-Ang University School of Medicine
Ethics committee address [1] 259938 0
Chung-Ang University College of Medicine 224-1 Heukseok-dong, Dongjak-gu Seoul, 156-755, Korea
Ethics committee country [1] 259938 0
Korea, Republic Of
Date submitted for ethics approval [1] 259938 0
08/03/2008
Approval date [1] 259938 0
08/04/2008
Ethics approval number [1] 259938 0
c2009014(201)

Summary
Brief summary
The parietal component is incisional pain experienced at the port sites and visceral component is deep intra-abdominal pain related to diaphragmatic irritation caused by pnemoperitoneum and postcholecystectomy wound. Shoulder tip pain is presumably referred pain related to distension of diaphragm caused by pneumoperitoneum and resultant phrenic nerve neuropraxia.The aim of our prospective, randomized, double-blind study was to evaluate the intensity of visceral, parietal and shoulder tip pain, and to determine the efficacy of peritrocal injection and intraperitoneal instillation of ropivacaine on each pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31827 0
Address 31827 0
Country 31827 0
Phone 31827 0
Fax 31827 0
Email 31827 0
Contact person for public queries
Name 15074 0
Hyun Kang
Address 15074 0
Department of Anaesthesiology and Pain Medicine Chung-Ang University College of Medicine 224-1 Heukseok-dong, Dongjak-gu Seoul, 156-755, Korea
Country 15074 0
Korea, Republic Of
Phone 15074 0
+82-2-6299-2571, 2579, 2586
Fax 15074 0
+82-2-6299-2585
Email 15074 0
roman00@naver.com
Contact person for scientific queries
Name 6002 0
Hyun Kang
Address 6002 0
Department of Anaesthesiology and Pain Medicine Chung-Ang University College of Medicine 224-1 Heukseok-dong, Dongjak-gu Seoul, 156-755, Korea
Country 6002 0
Korea, Republic Of
Phone 6002 0
+82-2-6299-2571, 2579, 2586
Fax 6002 0
+82-2-6299-2585
Email 6002 0
roman00@naver.com

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