Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000687392
Ethics application status
Approved
Date submitted
11/04/2017
Date registered
12/05/2017
Date last updated
12/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of local anesthetic infiltration to the nerves which lies on pectoral (chest) muscles on postoperative ( after operation) analgesia and opioid ( narcotic analgesics) consumption in aesthetic breast surgery operation.
Scientific title
The effect of pectoral nerve blocks on postoperative analgesia and opioid consumption in aesthetic breast surgery operation.
Secondary ID [1] 291653 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
postoperative pain following breast reconstruction surgery 302805 0
Condition category
Condition code
Anaesthesiology 302302 302302 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
At the end of breast surgery operation anesthesiologists will perform pectoral nerve blocks patients in intervention group. After skin disinfection first anesthesiologists will give 20 ml %0.25 bupivacaine to fascia which lies between pectoralis minor and serratus anterior muscles between 3. and 4. ribs guided under ultrasound view. Then the same amount of bupivacaine will be given fascia which lies between pectoralis major and minor muscles. We will use appropriate needles for this intervention.It will take approximately 5 minutes.
Intervention code [1] 297738 0
Treatment: Drugs
Comparator / control treatment
no treatment
Control group
Active

Outcomes
Primary outcome [1] 301710 0
postoperative pain score which assessed with visual analog scale ( VAS)
Timepoint [1] 301710 0
Postoperative 0,1,2,4,6,8,12 and 24. hours
Secondary outcome [1] 333642 0
Amount of postoperative opioid consumption for analgesia. which assessed with medical records and Patient controlled analgesia records.
Timepoint [1] 333642 0
postoperative 0,1,2,4,6,8,12 and 24. hours

Eligibility
Key inclusion criteria
1) Will undergo Aesthetic breast surgery operation
2)between 20-65 years old
3)American Society of Anesthesiologists (ASA) physical status I-II patients.
Minimum age
20 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1)antiepileptic drug use
2)Known allergy to study drugs
3)Severe renal or hepatic disease
4)Psychiatric disorders
5) Routine use of opioids or NSAI drugs
6)Pregnancy or lactation
7)Neurpathic disorders
8) Rejects study participation or using patient controlled analgesia device

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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/05/2017
Actual
Date of last participant enrolment
Anticipated
30/04/2018
Actual
Date of last data collection
Anticipated
2/05/2018
Actual
Sample size
Target
54
Accrual to date
Final
Recruitment outside Australia
Country [1] 8785 0
Turkey
State/province [1] 8785 0
Konya

Funding & Sponsors
Funding source category [1] 296152 0
University
Name [1] 296152 0
Baskent University
Country [1] 296152 0
Turkey
Primary sponsor type
University
Name
Baskent University
Address
Taskent Caddesi (Eski 1. Cadde) 77. Sokak (Eski 16. Sokak) No:11 06490 Bahcelievler / ANKARA
Country
Turkey
Secondary sponsor category [1] 295083 0
None
Name [1] 295083 0
Address [1] 295083 0
Country [1] 295083 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297398 0
Baskent University Clinical Research Ethical Committee
Ethics committee address [1] 297398 0
Taskent Caddesi 77. Sokak No:11 06490 Bahcelievler Cankaya/ Ankara
Ethics committee country [1] 297398 0
Turkey
Date submitted for ethics approval [1] 297398 0
12/12/2016
Approval date [1] 297398 0
13/01/2017
Ethics approval number [1] 297398 0
KA 16/358

Summary
Brief summary
Using opioids for postoperative analgesia is a standard modality. But opioid related side effects like nausea-vomiting, respiratory depression, urinary retention, Pruritus limits its use. Peripheral nerve and truncus block with local anesthetics can improve postoperative analgesia and reduce opioid requirement.
Our primary purpose in this study ; to investigate effect of pectoral nerve blocks on postoperative analgesia and total opioid consumption in aesthetic breast surgery
operation..
We will take written informed consent for all patients before the procedure. We will record age, height, weight, American Society of Anesthesiologists (ASA) physical status of all patients.We will randomize patients into two group with computer program.In the operation room, we will routinely monitor electrocardiography, peripheric oxygen saturation and blood pressure.Standard anesthesia induction will perform for general anesthesia.
At the end of breast surgery operation we will perform pectoral nerve blocks patients in intervention group. After skin disinfection first we will give 20 cc %0.25 bupivacaine fascia which lies between pectoralis minor and serratus anterior muscles between 3. and 4. ribs guided under ultrasound view. Then the same amount of bupivacaine will be given fascia which lies between pectoralis major and minor muscles. We will use appropriate needles for this intervention.It will take approximately 5 minutes. Both group ( control and intervebntion group) will take same postoperative analgesics routinely.
Postoperative analgesia will provided with patient controlled analgesia (PCA) device which contains opioid drugs. Postoperative analgesia will measure with visual analog scale for pain and opioid consumption with PCA datas postoperative 0,1,2,4,6,8,12 and 24. hours .
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73918 0
Mr Huseyin Ulas Pinar
Address 73918 0
Baskent University Konya Research Center Anesthesiology Department
Hocacihan mah. saray cad. no:1 Selcuklu /Konya
Postal Code : 42080
Country 73918 0
Turkey
Phone 73918 0
+905055251992
Fax 73918 0
+903322570637
Email 73918 0
[email protected]
Contact person for public queries
Name 73919 0
Mr Huseyin Ulas Pinar
Address 73919 0
Baskent University Konya Research Center Anesthesiology Department
hocacihan mah saray cad No: 1 Selcuklu/Konya
Postal Code : 42080
Country 73919 0
Turkey
Phone 73919 0
+905055251992
Fax 73919 0
+903322570637
Email 73919 0
[email protected]
Contact person for scientific queries
Name 73920 0
Mr Huseyin Ulas Pinar
Address 73920 0
Baskent University Konya Research Center Anesthesiology Department
hocacihan mah saray cad No: 1 Selcuklu/Konya
Postal Code : 42080
Country 73920 0
Turkey
Phone 73920 0
+905055251992
Fax 73920 0
+903322570637
Email 73920 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
SourceTitleYear of PublicationDOI
EmbasePectoral nerve (PECs) block for postoperative analgesia-a systematic review and meta-analysis with trial sequential analysis.2020
N.B. These documents automatically identified may not have been verified by the study sponsor.