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Trial registered on ANZCTR


Registration number
ACTRN12616001708448
Ethics application status
Approved
Date submitted
17/11/2016
Date registered
13/12/2016
Date last updated
24/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Postoperative analgesic efficacy of ketamine added to bupivacaine in ultrasound guided transversus abdominis plane block for laparoscopic cholecystectomy
Scientific title
Postoperative analgesic efficacy of ketamine added to bupivacaine in ultrasound guided transversus abdominis plane block for laparoscopic cholecystectomy
Secondary ID [1] 290101 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
postoperative analgesia 301230 0
Condition category
Condition code
Surgery 300076 300076 0 0
Other surgery
Anaesthesiology 300986 300986 0 0
Pain management
Oral and Gastrointestinal 300989 300989 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
The patients ' demographic data was recorded. The patients will be divided into two groups. Patients distributed to groups with closed envelope technique
Group I (n=60): control group.
All transversus abdominis plane blocks were performed under ultrasound guidance after induction of anesthesia, before beginning of surgery by the same anesthesiologist who performed block at least 20 times. 1mg/kg Bupivacaine (Marcaine (R) AstraZeneca: Istanbul, Turkey)+ Saline 0.9% (Izotonik sodyum klorur (R) (Eczacibasi: Istanbul, Turkey) ( total 40ml) injected in the transversus abdominis fascial plane under direct visualization.
Group II (n=60): 1mg/kg Bupivacaine (Marcaine (R) AstraZeneca: Istanbul, Turkey)+ 0.5 mg/kg ketamine (Ketalar (R) Pfizer: Istanbul, Turkey)+ Saline 0.9% (Izotonik sodyum klorur (R) (Eczacibasi: Istanbul, Turkey) (total 40ml).

The patients received patient-controlled intravenous analgesia (PCA) with 90 ml normal saline + 500 mg tramadol (Tramosel (R), Haver, Istanbul, Turkey) for postoperative pain management (bolus dose: 5 ml, lockout period: 20 minutes,without loading dose). All patients received intravenous analgesia via the same type of PCA (Patient Controlled Analgesia) device for 24 hours period.
When the pain level is higher than three (0=no pain; 10=severe pain), the patient can use the patient controlled analgesia pump. If the pain still exist, additional analgesic will be applied by the same anesthesiologist who assessed outcomes and the number of additional analgesic was recorded..
Intervention code [1] 295847 0
Treatment: Drugs
Comparator / control treatment
Group II (n=60)
All transversus abdominis plane blocks were performed under ultrasound guidance,
1mg/kg Bupivacaine (Marcaine (R) AstraZeneca: Istanbul, Turkey)+ 0.5 mg/kg Ketamine (Ketalar (R) Pfizer: Istanbul, Turkey)+ Saline 0.9% (Izotonik sodyum klorur (R) (Eczacibasi: Istanbul, Turkey) (total 40ml) injected in the transversus abdominis fascial plane under direct visualization.


Control group
Active

Outcomes
Primary outcome [1] 299547 0
rate of analgesic consumption in the 24 hours after surgery

Datas of analgesic agent consumption are assessed by review of medical records. Analgesic consumption will be calculated by the total amount of analgesic agents spent on Patient-controlled analgesia (PCA)
Timepoint [1] 299547 0
24 hours post surgery
Primary outcome [2] 299548 0
time of first analgesic requirement
this information is taken from patients themselves
Timepoint [2] 299548 0
at any time in the 24 hours
Primary outcome [3] 299549 0
Pain, assessed by visual analogue scale at rest and during movement.
Timepoint [3] 299549 0
at 0-2-4-8-12-24. hours
Secondary outcome [1] 327493 0
Adverse effects (itching, allergies, nausea, vomiting, urinary retention, constipation, respiratory depression, bradycardia, hypotension, dizziness ,hallucination i.e.)
Timepoint [1] 327493 0
during intraoperative process and 24 hours post surgery

Adverse events were recorded. If adverse events were recognized, They were evaluated according to Common Terminology Criteria for Adverse Events (CTC-AE) ver. 4.0.
This adverse events listed are assessed as recorded by treating clinician in the medical records

Eligibility
Key inclusion criteria
elective surgery
laparoscopic cholecystectomy
ASA (American Society of Anesthesiologist) Score) I-II
who can talk turkish language.
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
blood coagulation pathologies
allergies against local anaesthetics
inability to understand the study protocol
body mass index >30
infection on the block area


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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety/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] 8204 0
Turkey
State/province [1] 8204 0
Bursa

Funding & Sponsors
Funding source category [1] 294472 0
Self funded/Unfunded
Name [1] 294472 0
Demet Ozer
Address [1] 294472 0
Bursa Yuksek Ihtisas Training Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood /Emniyet Street/16310 Yildirim/Bursa
Country [1] 294472 0
Turkey
Funding source category [2] 294634 0
Self funded/Unfunded
Name [2] 294634 0
Derya Karasu
Address [2] 294634 0
Bursa Yuksek Ihtisas Training Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood /Emniyet Street/16310 Yildirim/Bursa
Country [2] 294634 0
Turkey
Primary sponsor type
Individual
Name
Derya Karasu
Address
Bursa Yuksek Ihtisas Training Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood /Emniyet Street/16310 Yildirim/Bursa
Country
Turkey
Secondary sponsor category [1] 293341 0
Individual
Name [1] 293341 0
Canan Yilmaz
Address [1] 293341 0
Bursa Yuksek Ihtisas Training Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood /Emniyet Street/16310 Yildirim/Bursa
Country [1] 293341 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295908 0
Yuksek Ihtisas Training and Education Hospital Clinical Researc Ethics Committee
Ethics committee address [1] 295908 0
Bursa Yuksek Ihtisas Training Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood /Emniyet Street/16310 Yildirim/Bursa
Ethics committee country [1] 295908 0
Turkey
Date submitted for ethics approval [1] 295908 0
15/08/2016
Approval date [1] 295908 0
05/10/2016
Ethics approval number [1] 295908 0
2011-KAEK-25 2016/17-01

Summary
Brief summary
Purpose: To study postoperative analgesic efficacy of ketamine added to bupivacaine in ultrasound guided transversus abdominis plane block for laparoscopic cholecystectomy.

Methods: In this study the patients who can speak Turkish and who have chololithiasis and planned elective laporoscophic cholecistectomy surgery, aged between 18-75 years with ASA (American Society of Anesthesiologist) Score I-II were included. We excluded patients with blood coagulation pathologies, allergies against local anaesthetics , inability to understand the study protocol, body mass index greater than thirty or infection on the block area.

After induction of anaesthesia, anaesthetists placed the bilateral transversus abdominis plane block after visualising with an ultrasound scan and then the operation was allowed.
The patients divided into two groups :
Group I (n=60): control group. 1mg/kg Bupivacaine (Marcaine (R) AstraZeneca: Istanbul, Turkey)+ Saline 0.9% (Izotonik sodyum klorur solusyonu (R) (Eczacibasi: Istanbul, Turkey) ( total 40ml).
Group II (n=60): 1mg/kg Bupivacaine (Marcaine (R) AstraZeneca: Istanbul, Turkey)+ 0.5 mg/kg ketamine (Ketalar (R) Pfizer: Istanbul, Turkey)+ Saline 0.9%(Izotonik sodyum klorur solusyonu (R) (Eczacibasi: Istanbul, Turkey) (total 40ml).

After the operation, to obtain minimum level of pain, patients controlled analgesia pump was applied via intravenous way to the patients. Then the level of pain was observed through the visual analog scale at 0-2-4-8-12-24h postoperatively both while coughing and at rest.

When the pain level is higher than three (0=no pain; 10=severe pain), the patient can use the patient controlled analgesia pump. If the pain still exist, additional analgesic was applied and the number of additional analgesic will be recorded accordingly.Results: 108 patients completed the study: 53 in Group I and 55 in Group II. For Group II, postoperatively at 0, 2, 4 and 24. hours VAS scores at rest and 0, 2, 4, 12 and 24 hours dynamic VAS scores were significantly lower than Group I (p<0.05).Moreover, the time to first analgesic requirement was longer significantly than Group I (p<0.0001).We couldn’t find any significant difference between the groups in terms of the total tramadol consumption.
Conclusions: We concluded that TAP block with bupivacaine and ketamine combination increases the time until the first request for rescue analgesic and it provides effective analgesia on postoperative period after laparoscopic cholecystectomy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68858 0
Dr Demet Ozer
Address 68858 0
Bursa Yuksek Ihtisas Training and Education Hospital Clinic of Anesthesiology and Reanimation Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/Bursa

Country 68858 0
Turkey
Phone 68858 0
+9055059045989
Fax 68858 0
Email 68858 0
drderyatopuz@gmail.com
Contact person for public queries
Name 68859 0
Dr Derya Karasu
Address 68859 0
Bursa Yuksek Ihtisas Training and Education Hospital Clinic of Anesthesiology and Reanimation Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/Bursa
Country 68859 0
Turkey
Phone 68859 0
+90505728117
Fax 68859 0
Email 68859 0
dr_cnnylmz@yahoo.com
Contact person for scientific queries
Name 68860 0
Dr Derya Karasu
Address 68860 0
Bursa Yuksek Ihtisas Training and Education Hospital Clinic of Anesthesiology and Reanimation Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/Bursa
Country 68860 0
Turkey
Phone 68860 0
+905057281175
Fax 68860 0
Email 68860 0
drderyatopuz@gmail.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