Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12615001297516
Ethics application status
Approved
Date submitted
25/09/2015
Date registered
27/11/2015
Date last updated
27/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of postoperative pain scores with deep versus moderate neuromuscular blockade during laparoscopic cholecystectomy.
Scientific title
In patients undergoing laparoscopic cholecystectomy, what is the effect of deep versus moderate muscle blockade on postoperative pain scores?
Secondary ID [1] 287549 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
postoperative pain 296326 0
cholecystitis 296740 0
Condition category
Condition code
Anaesthesiology 296602 296602 0 0
Pain management
Oral and Gastrointestinal 296978 296978 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1: Deep neuromuscular blockade with bolus intraveneous 1 mg/kg rocuronium for 8 mmHg intraabdominal pressure for pneumoperitoneum at the beginning of the procedure. 5% carbon dioxide (CO2) at 37 degrees Celsius and 50% humidity was used for pneumoperitoneum from time of incision to time of closure of the abdomen. 0.1-0.2 mg/kg rocuronium was administered multiple doses at clinical discretion of anaesthetist to maintain deep neuromuscular blockade during surgery if post-tetanic count >1. Group 2: moderate neuromuscular blockade with bolus intraveneous 0.5 mg/kg rocuronium for 12 mmHg intraabdominal pressure for pneumoperitoneum at the beginning of the procedure. 5% carbon dioxide (CO2) at 37 degrees Celsius and 50% humidity was used for pneumoperitoneum from time of incision to time of closure of the abdomen. No further rocuronium was administered for moderate blockade.
Intervention code [1] 292951 0
Treatment: Drugs
Comparator / control treatment
Group 2:Moderate neuromuscular blocade with bolus intraveneous 0,5 mg/kg rocuronium at the beginning of the procedure and no further rocuronium was administered during the surgery.
Control group
Active

Outcomes
Primary outcome [1] 296217 0
Effect of the deep and moderate muscle blockade on postoperative pain scores. Assessment was done with 11 point numerical rating scale.
Timepoint [1] 296217 0
postoperative pain assessment at 1, 2 ,4, 8,12, 18 hours
Secondary outcome [1] 317859 0
Comparision of the low (8mmHg) and standard(12mmHg) insufflation pressures affect on surgical space conditions during the laparoscopy.
Timepoint [1] 317859 0
assessment of the surgical area with four point scale and numeric rating scale after initiation and at the end of the surgery.
Secondary outcome [2] 317860 0
Comparision of the low (8mmHg) and standard(12mmHg) insufflation pressures affect on postoperative pain scores used 11 point numeric rating scale
Timepoint [2] 317860 0
postoperative pain assessment at 1, 2 ,4, 8,12, 18 hours

Eligibility
Key inclusion criteria
ASA(American Society of Anesthesiologists) 1-2 Patients
Undergo laparoscopic cholecystectomy
Minimum age
20 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Body Mass Index greater than 35
Body Mass Index less than 18
Neurological Disorders
Coagulopathy
Allergic to narcotic and NSAID agents
Cancer patients
Chronic Pain Disorders

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/12/2014
Date of last participant enrolment
Anticipated
Actual
31/05/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
50
Recruitment outside Australia
Country [1] 7186 0
Turkey
State/province [1] 7186 0
Istanbul

Funding & Sponsors
Funding source category [1] 292117 0
Self funded/Unfunded
Name [1] 292117 0
Country [1] 292117 0
Primary sponsor type
Hospital
Name
Istanbul training and research hospital
Address
Abdurrahman nafiz Gurman Street postal code:34098 Fatih /Istanbul
Country
Turkey
Secondary sponsor category [1] 290793 0
None
Name [1] 290793 0
Address [1] 290793 0
Country [1] 290793 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293745 0
Istanbul training and research hospital
Ethics committee address [1] 293745 0
Kasap Ilyas district Org.Abdurrahman Nafiz Gurman street Postal code:34098 FATIH
Ethics committee country [1] 293745 0
Turkey
Date submitted for ethics approval [1] 293745 0
12/08/2015
Approval date [1] 293745 0
14/08/2015
Ethics approval number [1] 293745 0
690

Summary
Brief summary
We assessed the postoperative pain scores with 11 point numeric rating scale for deep and moderate muscle blockade after laparoscopic cholecystectomy. In addition we assessed the surgical space conditions during surgery with 4-point scale and numeric rating scale.
Trial website
Trial related presentations / publications
Public notes
ethics approval was not attained prior to recruitment of the first participant. because our ethical comitee did not approved. Then we finished the recruitment, they approved the study so ethical comitee date was late.

Contacts
Principal investigator
Name 60626 0
A/Prof VEYSEL ERDEN
Address 60626 0
Istanbul Research and Education Hospital Kasap Ilyas district Org.Abdurrahman Nafiz Gurman street Postal code:34098 FATIH/ ISTANBUL
Country 60626 0
Turkey
Phone 60626 0
+90 212 459 60 00
Fax 60626 0
Email 60626 0
[email protected]
Contact person for public queries
Name 60627 0
Dr CIHAN GULER
Address 60627 0
Istanbul Research and Education Hospital Kasap Ilyas district Org.Abdurrahman Nafiz Gurman street Postal code:34098 FATIH/ ISTANBUL
Country 60627 0
Turkey
Phone 60627 0
+90 212 459 60 00
Fax 60627 0
Email 60627 0
[email protected]
Contact person for scientific queries
Name 60628 0
Dr CIHAN GULER
Address 60628 0
Istanbul Research and Education Hospital Kasap Ilyas district Org.Abdurrahman Nafiz Gurman street Postal code:34098 FATIH/ ISTANBUL
Country 60628 0
Turkey
Phone 60628 0
+90 212 459 60 00
Fax 60628 0
Email 60628 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.