Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619001029189
Ethics application status
Approved
Date submitted
16/06/2019
Date registered
18/07/2019
Date last updated
18/07/2019
Date data sharing statement initially provided
18/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of local anesthetic infiltration to the nerves which lies in the axilla on postoperative analgesia and opioid consumption in cancer breast surgery.
Scientific title
Comparison of PECs II block with Axillary infiltration of local anesthetic on postoperative analgesia in patients undergoing cancer breast surgery : a randomized clinical trial.
Secondary ID [1] 298442 0
none
Universal Trial Number (UTN)
U1111-1234-8654
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative pain 313177 0
Breast cancer 313559 0
Breast surgery 313560 0
Condition category
Condition code
Anaesthesiology 311640 311640 0 0
Pain management
Cancer 311924 311924 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Thirty minutes prior induction of general anesthesia, Axillary Infiltration group: Patient in the supine position with the arm abducted. An anesthesiologist skilled with ultrasound guided regional anesthesia placed the ultrasound probe at the midclavicular level inferolaterally to locate the axillary artery and vein, and then moved laterally until the lower border of the pectoralis minor is identified at the level of the third or fourth rib. Needle advanced in the plane mode until the tip entered the area below the pectoralis half distance between the axillary vein and the rib and 20.5 ml of ropivacaine 0.5% was injected. The anesthesiologist is able to be sure that the quantity injected under ultrasound is in the fatty area of the axilla.
Intervention code [1] 314686 0
Treatment: Drugs
Comparator / control treatment
Thirty minutes prior induction of general anesthesia the Pec's group (Control Group): Patient in the supine position with the arm abducted. The anesthesiologist placed the ultrasound probe at the midclavicular level inferolaterally to locate the axillary artery and vein, and then moved laterally until pectoralis minor and serratus anterior muscles were identified at level of the third rib. Needle advanced in the plane of probe from medial to lateral in an oblique manner until the tip entered the plane between pectoralis major and minor and ropivacaine 0.5%, 10 ml was injected. After depositing the local anesthetic, the needle was advanced further until it lay in the potential space in the fascia between pectoralis minor and serratus anterior muscles, and ropivacaine 0.5%, 15 ml was deposited in this space.
Control group
Active

Outcomes
Primary outcome [1] 320344 0
The duration of analgesia (time to first rescue analgesia after administration of block).
The time of performance of the block was noted by the anesthesiologist, the time of first dose of narcotics administered to the patient in the post operative period was noted by the nurse incharge on the floor. The duration of analgesia (time to first rescue analgesia after administration of block) can be calculated subsequently.
Timepoint [1] 320344 0
up to 24 hours post-intervention.
Primary outcome [2] 320345 0
Postoperative pain: assessed using a visual analog scale (VAS, 0–10; 0=no pain and 10=worst imaginable pain)
Timepoint [2] 320345 0
recorded at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 24 hours.
Secondary outcome [1] 371281 0
Amount of postoperative opioid consumption for analgesia. which assessed with medical records and Patient controlled analgesia records.
Timepoint [1] 371281 0
recorded after 24 hours

Eligibility
Key inclusion criteria
1. ASA grade I–II
2. Female patients
3. Breast Surgery
4. Fasting overnight
5. Informed consent
Minimum age
18 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Infection at the block site
2. Coagulopathy
3. Morbid obesity (BMI >40 kg m-2)
4. Allergy to local anesthetics
5. Decreased pulmonary reserve
6. Major cardiac disorders
7. Renal dysfunction
8. Pre-existing neurological de?cits
9. Psychiatric illness

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)
Simple randomisation using a randomisation table created by computer software: Simple Random sample generator application on mobile software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/08/2019
Actual
Date of last participant enrolment
Anticipated
15/10/2019
Actual
Date of last data collection
Anticipated
17/10/2019
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 21584 0
Lebanon
State/province [1] 21584 0
BEIRUT

Funding & Sponsors
Funding source category [1] 302988 0
Self funded/Unfunded
Name [1] 302988 0
Maroun B. Ghabach, M.D
Country [1] 302988 0
Lebanon
Primary sponsor type
Individual
Name
Maroun B, Ghabach
Address
Rosary Hospital
Department of Anesthesia
Gemayze, Beirut.
PO Box: 175-272
Country
Lebanon
Secondary sponsor category [1] 302948 0
None
Name [1] 302948 0
None
Address [1] 302948 0
Country [1] 302948 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303539 0
Medical Ethics Committee
Ethics committee address [1] 303539 0
Caroline Roumolian, M.D
General Secretary,
Medical Ethics Committee
Rosary Hospital
Gemayze , 175272
Beirut, Lebanon
Tel:+9613444865
Email: [email protected]
Ethics committee country [1] 303539 0
Lebanon
Date submitted for ethics approval [1] 303539 0
15/04/2019
Approval date [1] 303539 0
15/05/2019
Ethics approval number [1] 303539 0
A3-2019

Summary
Brief summary
In our study we introduced a new technique for postoperative control of pain in patients undergoing breast surgery. The technique consisted of infiltrating the axillary fat area with ropivacaine by using ultrasound.
Hypothesis: the new technique is effective as Pec's II block on postoperative analgesia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94014 0
Prof Maroun B. Ghabach
Address 94014 0
Rosary Hospital
Department of Anesthesia
Gemayze, Beirut.
PO Box: 175-272
Country 94014 0
Lebanon
Phone 94014 0
+9613451882
Fax 94014 0
+9611440800-1252
Email 94014 0
[email protected]
Contact person for public queries
Name 94015 0
Prof Maroun B. Ghabach
Address 94015 0
Rosary Hospital
Department of Anesthesia
Gemayze, Beirut.
PO Box: 175-272
Country 94015 0
Lebanon
Phone 94015 0
+9613451882
Fax 94015 0
+9611440800-1252
Email 94015 0
[email protected]
Contact person for scientific queries
Name 94016 0
Prof Maroun B. Ghabach
Address 94016 0
Rosary Hospital
Department of Anesthesia
Gemayze, Beirut.
PO Box: 175-272
Country 94016 0
Lebanon
Phone 94016 0
+9613451882
Fax 94016 0
+9611440800-1252
Email 94016 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.