ANZCTR - Registration

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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]

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

Condition category

Condition code

Anaesthesiology

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]

Treatment: Drugs

Comparator / control treatment

no treatment

Control group

Active

Outcomes

Primary outcome [1]

postoperative pain score which assessed with visual analog scale ( VAS)

Timepoint [1]

Postoperative 0,1,2,4,6,8,12 and 24. hours

Secondary outcome [1]

Amount of postoperative opioid consumption for analgesia. which assessed with medical records and Patient controlled analgesia records.

Timepoint [1]

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Turkey

State/province [1]

Konya

Funding & Sponsors

Funding source category [1]

University

Name [1]

Baskent University

Address [1]

Taskent Caddesi (Eski 1. Cadde) 77. Sokak (Eski 16. Sokak) No:11 06490 Bahcelievler / ANKARA

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Baskent University Clinical Research Ethical Committee

Ethics committee address [1]

Taskent Caddesi 77. Sokak No:11 06490 Bahcelievler Cankaya/ Ankara

Ethics committee country [1]

Turkey

Date submitted for ethics approval [1]

12/12/2016

Approval date [1]

13/01/2017

Ethics approval number [1]

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

Mr Huseyin Ulas Pinar

Address

Baskent University Konya Research Center Anesthesiology Department
Hocacihan mah. saray cad. no:1 Selcuklu /Konya
Postal Code : 42080

Country

Turkey

Phone

+905055251992

Fax

+903322570637

huseyinpinar2002@yahoo.com

Contact person for public queries

Name

Huseyin Ulas Pinar

Address

Baskent University Konya Research Center Anesthesiology Department
hocacihan mah saray cad No: 1 Selcuklu/Konya
Postal Code : 42080

Country

Turkey

Phone

+905055251992

Fax

+903322570637

huseyinpinar2002@yahoo.com

Contact person for scientific queries

Name

Huseyin Ulas Pinar

Address

Baskent University Konya Research Center Anesthesiology Department
hocacihan mah saray cad No: 1 Selcuklu/Konya
Postal Code : 42080

Country

Turkey

Phone

+905055251992

Fax

+903322570637

huseyinpinar2002@yahoo.com

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	Pectoral 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.

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Documents added manually

Documents added automatically