ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617000891325

Ethics application status

Approved

Date submitted

26/05/2017

Date registered

16/06/2017

Date last updated

31/01/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

Comparison of Subcostal Transversus Abdominis Plane Block and Quadratus Lumborum Block in Laparoscopic Cholecystectomy with Ultrasonography as a Preventive Analgesia Method

Scientific title

Comparison of Subcostal Transversus Abdominis Plane Block and Quadratus Lumborum Block in Laparoscopic Cholecystectomy with Ultrasonography as a Preventive Analgesia Method

Secondary ID [1]

nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Gallstones/Chololithiasis

Condition category

Condition code

Surgery

Other surgery

Anaesthesiology

Pain management

Oral and Gastrointestinal

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=50): Subcostal transversus abdominis plane block group
Subcostal 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. 1,5 mg/kg %0.25 Bupivacaine (Marcaine (R) AstraZeneca: Istanbul, Turkey)injected in the transversus abdominis fascial plane under direct visualization.
Group II (n=50):Quadratus lumborum block group
Quadratus lumborum 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. 1,5mg/kg %0,25 Bupivacaine (Marcaine (R) AstraZeneca: Istanbul, Turkey)injected in the quadratus lumborum fascial plane under direct visualization.
The patients received patient-controlled intravenous analgesia (PCA) with 54 ml normal saline + 300 mg tramadol (Tramosel (R), Haver, Istanbul, Turkey) for postoperative pain management (bolus dose: 5 ml, lockout period: 30 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]

Treatment: Drugs

Comparator / control treatment

Group II (n=50):Quadratus lumborum block group
Quadratus lumborum 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. 1,5mg/kg %0,25 Bupivacaine (Marcaine (R) AstraZeneca: Istanbul, Turkey)injected in the quadratus lumborum fascial plane under direct visualization.

Control group

Active

Outcomes

Primary outcome [1]

rate of analgesic consumption in the 24 hours after surgery between two blocks groups.
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]

24 hours post surgery

Primary outcome [2]

time of first analgesic requirement
this information is taken from patients themselves

Timepoint [2]

at any time in the 24 hours

Primary outcome [3]

Pain, assessed by visual analogue scale at rest and during coughing

Timepoint [3]

at 0-1-6-12-24. hours

Secondary outcome [1]

Adverse effects (itching, allergies, nausea, vomiting, urinary retention, constipation, respiratory depression, bradycardia, hypotension, dizziness ,hallucination i.e.)

Timepoint [1]

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
laparosopic cholecystectomy
ASA (American Society of Anesthesiologist) Score) I-II
who can talk turkish language.

Minimum age

18 Years

Maximum age

75 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

blood coagulation pathologies
allergies against local anaesthetics
inability to understand the study protocol
body mass index >35
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

10/07/2017

Actual

10/07/2017

Date of last participant enrolment

Anticipated

Actual

2/10/2017

Date of last data collection

Anticipated

Actual

3/10/2017

Sample size

Target

120

Accrual to date

Final

107

Recruitment outside Australia

Country [1]

Turkey

State/province [1]

bursa

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

cagdas baytar

Address [1]

Bursa Yuksek Ihtisas Training Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood /Emniyet Street/16310 Yildirim/Bursa

Country [1]

Turkey

Funding source category [2]

Self funded/Unfunded

Name [2]

canan yilmaz

Address [2]

Bursa Yuksek Ihtisas Training Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood /Emniyet Street/16310 Yildirim/Bursa

Country [2]

Turkey

Funding source category [3]

Self funded/Unfunded

Name [3]

derya karasu

Address [3]

Bursa Yuksek Ihtisas Training Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood /Emniyet Street/16310 Yildirim/Bursa

Country [3]

Turkey

Primary sponsor type

Individual

Name

canan yilmaz

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]

Individual

Name [1]

derya karasu

Address [1]

Bursa Yuksek Ihtisas Training Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood /Emniyet Street/16310 Yildirim/Bursa

Country [1]

Turkey

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bursa Uludag University Medicine Faculty Ethics Committee

Ethics committee address [1]

Ozluce neighborhood, 16059 Nilufer/Bursa/Turkey

Ethics committee country [1]

Turkey

Date submitted for ethics approval [1]

10/03/2017

Approval date [1]

28/03/2017

Ethics approval number [1]

2017-4/19

Summary

Brief summary

Purpose:Ultrasound-guided quadratus lumbar block and transversus abdominis are effective methods for analgesia in operations involving the abdominal region of the abdominal plane and are increasingly used. Many studies have shown that they provide less complications and longer effective analgesia than conventional analgesia regimens. In our clinic, it was planned to compare these methods, which are routinely used for preventive purposes, in terms of efficacy on pain. We aimed to contribute to the literature by comparing the obtained data with the existing literature information.

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 five or infection on the block area.

Demographic data (age, height, weight, gender, ASA) of the patients will be recorded. Patients will be divided into 2 groups of 100 patients according to closed envelope method.
Group 1 (n = 50): General anesthesia will be applied with the drugs applied in the patient's routine. Subcostal Transversus Abdominis Plane block will be performed in the presence of ultrasound after intubation. 1,5 mg / kg 0.25% Bupivacain will be applied on each side in our routine.
Group 2 (n = 50): General anesthesia will be applied with the drugs applied in the patient's routine. Post-intubation Quadratus Lumborum Block will be performed in the presence of ultrasound. Each side will be treated with 1,5 mg / kg 0.25% Bupivacain applied on the route.

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 0-1-6-12-24h 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

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr cagdas baytar

Address

Bursa Yuksek Ihtisas Training and Education Hospital Clinic of Anesthesiology and Reanimation Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/Bursa

Country

Turkey

Phone

+90 554 225 59 60

Fax

cagdasbaytar31@gmail.com

Contact person for public queries

Name

canan yilmaz

Address

Bursa Yuksek Ihtisas Training and Education Hospital Clinic of Anesthesiology and Reanimation Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/Bursa

Country

Turkey

Phone

+90 505 904 59 89

Fax

canan.yilmaz12@saglik.gov.tr

Contact person for scientific queries

Name

canan yilmaz

Address

Bursa Yuksek Ihtisas Training and Education Hospital Clinic of Anesthesiology and Reanimation Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/Bursa

Country

Turkey

Phone

+90 505 904 59 89

Fax

canan.yilmaz12@saglik.gov.tr

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

Source	Title	Year of Publication	DOI
Embase	Comparison of ultrasound-guided subcostal transversus abdominis plane block and quadratus lumborum block in laparoscopic cholecystectomy: A prospective, randomized, controlled clinical study.	2019	https://dx.doi.org/10.1155/2019/2815301

N.B. These documents automatically identified may not have been verified by the study sponsor.

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