Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000034538
Ethics application status
Approved
Date submitted
1/12/2014
Date registered
19/01/2015
Date last updated
8/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pre-emptive analgesia of intrapleural and serratus plane blocks for breast surgeries: A randomized prospective clinical trial
Scientific title
Pre-emptive Analgesia of intrapleural and serratus plane blocks on intra and post-operative analgesia for breast surgery patients
Secondary ID [1] 285736 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast surgeries for any indication, e.g. breast cancer, cosmetic surgery, etc.
 293621 0
Condition category
Condition code
Anaesthesiology 293909 293909 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
30 patients in each group will be randomized using closed envelops and a computer generated random numbers into 2 groups (30 patients each). Each block will be performed just after induction of anesthesia. Group I (intrapleural block): While the patient is in the supine position, the block will be performed using number 18 Touhy needle at the 5th intercostal space in the anterior midaxillary line. The needle will be introduced while the patient is disconnected from the ventilator to avoid lung injury or pneumothorax. Loss of resistance technique will be used to identify the intrapleural space. After negative aspiration test 40 ml of 0.25% levobupivacaine will be injected in the intrapleural space.
Group II (serratus plane block):
The patients will be in the supine position, and the ultrasound probe will be in the sagital plane over the mid clavicular region , then we will go inferiorly and laterally till we identify the 5th rib in the mid axillary line to identify the latissimus dorsi, teres major and serratus muscles. 22G needle will be introduced in-plane in relation to the ultrasound probe, then 0.4 ml/kg levobupivacaine 0.25% will be injected in the potential space superficial to the serratus anterior muscle. In the intra-operative period; if signs of sympathetic stimulation (increase in heart rate and mean arterial blood pressure more than 20 % from the baseline values despite adequate level of anesthesia) treated with iv bolus doses of fentanyl 0.5 micogram /Kg.
In the post-operative period: Visual Analogue Score (VAS). 0 = no pain, to 10 = the most severe pain, 0-3 = mild pain , 4-6 = moderate pain, >6 = severe pain
Patients with moderate or severe pain will receive diclofenac sodium 75 mg intramuscular injection.
(VAS) will be recorded at 1, 2, 4, 8, 12, 18, and 24 hours post-operatively.
Intervention code [1] 290691 0
Treatment: Drugs
Comparator / control treatment
The active control group is group I(Intra-pleural block group) in which 40 ml of 0.25% levobupivacaine will be injected in the intra-pleural space.
Control group
Active

Outcomes
Primary outcome [1] 293685 0
The duration of analgesia measured from the time of injection of the local anesthetic to the time of first request for analgesia (the first time the patient feels moderate or severe pain).
Timepoint [1] 293685 0
In the post-operative period: Visual Analogue Score (VAS). 0 = no pain, to 10 = the most severe pain, 0-3 = mild pain , 4-6 = moderate pain, >6 = severe pain.
(VAS) will be recorded at 1, 2, 4, 8, 12, 18,and 24 hours postoperatively.
Primary outcome [2] 293686 0
The quality of block
Timepoint [2] 293686 0
Will be assessed as follows:
Complete block: Patients who will not need fentanyl intra-operatively or diclofenac sodium injection 4 hours postoperatively.
Partial block: Patients who will need either fentanyl intra-operatively or diclofenac sodium injection 4 hours postoperatively.
Failed block: Patients who will need fentanyl intra-operatively and diclofenac sodium injection 4 hours postoperatively.
Secondary outcome [1] 311592 0
Analgesic consumption
Timepoint [1] 311592 0
Dose of fentanyl and diclofenac sodium is assessed from the time of injection of the local anesthetic until 4 hours post-operatively.
Secondary outcome [2] 311593 0
The occurrence of any complication related to the technique e.g pneumo-thorax, hemo-thorax.....etc will be recorded.
Timepoint [2] 311593 0
During performing the technique and the first 24 hours

Eligibility
Key inclusion criteria
Female patients with ASA clinical status I and II scheduled for breast surgery for any indication, e.g. breast cancer, cosmetic surgery, etc in the General Surgery Department, Tanta University Hospital, Egypt.
Minimum age
20 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with pulmonary disease (empyema, chronic obstructive pulmonary disease, Pulmonary disease, or previous cardio-thoracic surgery), allergy to the local anesthetic, uncooperative patients, and patients with bleeding abnormalities.

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)
The patients will be randomized using closed envelops into 2 groups (30 patients each).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated random numbers will be used.
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
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
For each group 26 patients will be required for the serratus plane block to increase the duration of analgesia by 20% (72 minutes) based on a previous pilot study in our department with 90 % power using a cutoff statistical significance of 0.05 % and a standard deviation of 80 and standardized difference of 0.9. We will use 30 patients in each group for more accurate statistical analysis. Quantitative data will be expressed as mean +/- SD and qualitative data and that which will not follow the normal distibution will be expressed as median and range will be analyzed using SPSS, P< 0.05 will be considered significant

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/08/2014
Actual
16/08/2014
Date of last participant enrolment
Anticipated
16/02/2015
Actual
16/08/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 6494 0
Egypt
State/province [1] 6494 0
Tanta, El Gharbia governorate

Funding & Sponsors
Funding source category [1] 290308 0
Self funded/Unfunded
Name [1] 290308 0
Hoda Alsaid Ahmed Ezz
Country [1] 290308 0
Egypt
Primary sponsor type
Individual
Name
Hoda Al Said Ahmed Ezz
Address
El Geish street, Anesthesia and Surgical Intensive Care Department, Tanta University Hospital, Faculty of Medicine, Tanta University, Tanta, El Gharbia Governorate, Egypt.
postal code:31257
Country
Egypt
Secondary sponsor category [1] 289019 0
Individual
Name [1] 289019 0
Ahmed Abd El-Aziz Shama
Address [1] 289019 0
El Geish street, Anesthesia and Surgical Intensive Care Department, Tanta University Hospital, Faculty of Medicine, Tanta University, Tanta, El Gharbia Governorate, Egypt.
postal code:31257
Country [1] 289019 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292014 0
Research Ethics Committee of the faculty of medicine ,Tanta Univerisity, Egypt.
Ethics committee address [1] 292014 0
Ethics committee country [1] 292014 0
Egypt
Date submitted for ethics approval [1] 292014 0
Approval date [1] 292014 0
13/08/2014
Ethics approval number [1] 292014 0
2674/08/14

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53058 0
A/Prof Hoda ALsaid Ahmed Ezz
Address 53058 0
El Geish street, anesthesia and surgical intensive care Department, Tanta University Hospital, Faculty of Medicine, Tanta University, Tanta, El Gharbia Governorate, Egypt.
postal code:31257
Country 53058 0
Egypt
Phone 53058 0
+20 1222768250
Fax 53058 0
Email 53058 0
[email protected]
Contact person for public queries
Name 53059 0
Abd El Reheem M. Dowidar
Address 53059 0
El Geish street, Anesthesia and Surgical Intensive Care Department, Tanta University Hospital, Faculty of Medicine, Tanta University, Tanta, El Gharbia Governorate, Egypt.
postal code:31257
Country 53059 0
Egypt
Phone 53059 0
+20 1223195015
Fax 53059 0
Email 53059 0
[email protected]
Contact person for scientific queries
Name 53060 0
Abd El Reheem M. Dowidar
Address 53060 0
El Geish street, Anesthesia and Surgical Intensive Care Department, Tanta University Hospital, Faculty of Medicine, Tanta University, Tanta, El Gharbia Governorate, Egypt.
postal code:31257
Country 53060 0
Egypt
Phone 53060 0
+20 1223195015
Fax 53060 0
Email 53060 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
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