Trial no.:	PACTR201707002385379	Date of Approval:	27/06/2017
Trial Status:	Registered in accordance with WHO and ICMJE standards

TRIAL DESCRIPTION

Public title

continuous pecs for MRM

Official scientific title

Continuous pectoral nerve block compared to intravenous opioid analgesia and continuous thoracic paravertebral block for postoperative analgesia in patients undergoing modified radical mastectomy

Brief summary describing the background and objectives of the trial

Breast cancer is the most common cancer among women that require breast surgery. [1,2] Acute postoperative pain is a risk factor for chronic postoperative pain after breast surgery [3] Effective postoperative pain management is necessary. Systemic opioids can be administered using patient-controlled devices but the analgesic effect can be limited and undesirable side effects may occur. [4] Thoracic paravertebral block (TPVB) consists in the administration of a local anesthetic solution close to the spinal cord nerve roots after their exit from the intervertebral foramen [5, 6]. Injection into the thoracic paravertebral space through a catheter demonstrates vertical diffusion lateral to the vertebral column between the parietal pleura and the endothoracic fascia [7, 8]. Continuous paravertebral nerve block has the advantages of equivalent analgesia as an epidural technique but with less risk of block failure, dural puncture, cord trauma, and clinically significant side effects, including hypotension. Additionally, urinary catheterization is not necessary. [9] Pectoral nerve (Pecs) blocks are ultrasound guided interfascial plane blocks that target tissue planes between the pectoralis major and minor (Pecs I), and the pectoralis minor and serratus anterior muscles (Pecs II) [10,11]. Targeting these planes with local anesthetic blocks the medial and lateral pectoral nerves, anterior divisions of the thoracic intercostal nerves from T2 to T6, long thoracic nerve, and thoracodorsal nerves providing analgesia to the anterior and lateral thoracic walls with an extension into axilla. Pecs blocks have shown excellent efficacy for analgesia after breast surgery.[12] The aim of the current study is to compare the effects of three techniques ; continuous thoracic paravertebral block, continuous Pectoral nerve block and PCA IV morphine on postoperative pain and rescue analg

Type of trial

RCT

Acronym (If the trial has an acronym then please provide)

Disease(s) or condition(s) being studied

postoperative pain,Surgery

Sub-Disease(s) or condition(s) being studied

Purpose of the trial

Treatment: Other

Anticipated trial start date

01/07/2017

Actual trial start date

01/08/2017

Anticipated date of last follow up

01/02/2018

Actual Last follow-up date

20/08/2018

Anticipated target sample size (number of participants)

90

Actual target sample size (number of participants)

90

Recruitment status

Completed

Publication URL

Secondary Ids	Issuing authority/Trial register
31585/06/17	Tanta University, Faculty of Medicine,Research Ethics Committee, Quality Assurance Unit

STUDY DESIGN
Intervention assignment	Allocation to intervention	If randomised, describe how the allocation sequence was generated	Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms	Masking	If masking / blinding was used
Parallel: different groups receive different interventions at same time during study	Randomised	permuted block randomisation	Sealed opaque envelopes	Masking/blinding used	Care giver/Provider,Outcome Assessors,Participants

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Control Group	Group I: IV patient controlled analgesia using morphine. (PCA-M	morphine loading dose of 1mg (bolus), a lockout interval of 7 min and a maximum dose of 34.2 mg per 4 h.	48 h	morphine PCA	30	Active-Treatment of Control Group
Experimental Group	Group II: Continuous thoracic paravertebral block. (TPVB):	An initial bolus of 10¿15 ml bupivacaine 0.125% is injected followed by a continuous infusion of bupivacaine, 0.125%, at a rate of 5 ml/hr.	48 h	continuous TPVB	30
Experimental Group	continuous pectoral nerve block. (Pecs):	After an initial bolus dose of 10 mL of 0.25% bupivacaine, a continuous infusion of 6 ml/h	48 h	continuous Pecs block	30

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
aged 20 ¿ 70 years, ASA I-III, undergoing modified radical mastectomy (MRM)	include body mass index > 35, mental disorders, any contraindication to regional anesthesia (e.g. local infection, coagulation abnormality, or patient refusal), known allergy to the study drug, pregnancy, drug or alcohol abuse daily intake of opioid analgesics.		20 Year(s)	70 Year(s)	Female

ETHICS APPROVAL

Has the study received appropriate ethics committee approval

Date the study will be submitted for approval

Date of approval

Name of the ethics committee

Yes

01/06/2017

Tanta University Faculty of Medicine Research Ethics Committee Quality Assurance Unit

Ethics Committee Address
Street address	City	Postal code	Country
10 Algeish street	Tanta	31527	Egypt

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	cumulative morphine consumption	24h postoperative 48h postoperative
Secondary Outcome	postoperative VAS	at 0, 1, 3, 6 , 12 , 24 and 48 hours postoperatively

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
Tanta University, Faculty of Medicine	10 Algeish street	Tanta	31951	Egypt

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
Tanta University, Faculty of Medicine	10 Algeish street	Tanta	31951	Egypt

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Secondary Sponsor	Department of anesthesia and surgical ICU	10 Algeish street	Tanta	31951	Egypt	Hospital
Primary Sponsor	Tanta University, Faculty of Medicine	10 Algeish street	Tanta	31951	Egypt	University

COLLABORATORS
Name	Street address	City	Postal code	Country
Shaimaa Farouk	1 Moheb street	Almahalla Alkobra	31951	Egypt

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	Shaimaa Farouk	Shaimaafarouk7777@yahoo.com	01270440771	1 Moheb street
City	Postal code	Country	Position/Affiliation
Almahalla Alkobra	31951	Egypt	Lecturer ofanesthesia and ICU
Role	Name	Email	Phone	Street address
Public Enquiries	Mohamed Mohye Eldin	Mohd_yazed75@yahoo.com	01120014472	55 Stad street
City	Postal code	Country	Position/Affiliation
Tanta	31951	Egypt	Lecturer ofanesthesia and ICU
Role	Name	Email	Phone	Street address
Scientific Enquiries	Mohamed Mohye Eldin	Mohd_yazed75@yahoo.com	01120014472	55 Stad street
City	Postal code	Country	Position/Affiliation
Tanta	31951	Egypt	Lecturer ofanesthesia and ICU

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria
No
URL	Results Available	Results Summary	Result Posting Date	First Journal Publication Date
	No
Result Upload 1:	Result Upload 2:	Result Upload 3:	Result Upload 4:	Result Upload 5:

Result URL Hyperlinks	Link To Protocol
Result URL Hyperlinks

Changes to trial information

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