Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000851369
Ethics application status
Approved
Date submitted
19/04/2017
Date registered
8/06/2017
Date last updated
8/10/2019
Date data sharing statement initially provided
8/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison between ketamine and dexmedetomidine as adjuvants in Pectoral Nerves Regional Blocks for perioperative pain control for patients undergoing breast cancer surgery
Scientific title
Comparison between the efficacy and the safety of ketamine and dexmedetomidine as adjuvants in PEC1 and PEC2 regional blocks for perioperative pain control for patients undergoing breast cancer surgery,A controlled prospective double blind randomized study.
Secondary ID [1] 291728 0
None
Universal Trial Number (UTN)
U1111-1195-6837
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
breast cancer surgery 302916 0
Condition category
Condition code
Anaesthesiology 302399 302399 0 0
Anaesthetics
Anaesthesiology 302400 302400 0 0
Pain management
Cancer 302601 302601 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomized double blind prospective study will be conducted on 90 patients aged 18 years or above undergoing modified radical mastectomy. Patients will be randomly assigned into three groups (30 patients each).Patients in group ketamine bupivacaine (KB) will receive PECs block with 30 ml of 0.25% bupivacaine added to ketamine hydrochloride 1mg/kg .Patients in group dexmedetomidine bupivacaine (DB) will receive PECs block with 30 ml of 0.25%bupivacaine added to dexmedetomidine 1ug/kg .Patients in bupivacaine group(B) will receive PECs block with 30 ml of 0.25%bupivacaine .


The local anaesthesia will be prepared by our hospital pharmacy in unlabeled 30 ml syringes according to the randomization table and will be handed to the anaesthetist before starting the procedure.Both the patients and the anesthetist will beblinded to the study drug.

In all patients general anesthesia will be induced using 2 µg/kg fentanyl, 2.5mg/kg propofol and 1 mg/kg lidocaine. Endotracheal intubation will be facilitated by 0.5 atracurium and will be maintained by 1 MAC sevoflurane in 50% Oxygen /air mixture in a low flow breathing system (FiO2 = 0.5) .
PECs block will be done in all patient by an anaesthetist blinded to the solution to be injected. PECs block will be done with an in plane Ultrasound guidance to inject 10 ml of the local anesthetic solution between pectoralis major and pectoralis minor muscles and 20 ml the needle is then advanced from the medial to lateral side parallel to the ultrasound beam and then 20ml of the solution is injected between the pectoralis minor and serratus anterior muscles
Intervention code [1] 297835 0
Treatment: Drugs
Comparator / control treatment
30 Patients in bupivacaine group(B) will receive PECs block with 30 ml of 0.25%bupivacaine
Control group
Active

Outcomes
Primary outcome [1] 301810 0
The total postoperative morphine consumption,

The patient will be transferred to the Post Anaesthesia Care Unit (PACU) and a trained nurse will be assigned to start PCA morphine pump .

Total postoperative morphine consumption for the first 24 hours postoperative( once the pain is expressed by the patient an initial morphine bolus of 0.1mg/kg followed by 1mg bolus with a lockout periods of 15 minutes with no background infusion allowed) ,
Timepoint [1] 301810 0
24 Hours post-operative
Primary outcome [2] 302013 0
The time of the first request of analgesic as recorded by nurse in patient charts
Timepoint [2] 302013 0
24 hours post-operative
Secondary outcome [1] 333932 0
pain scores at rest
pain score will be assessed using the numerical rating scale (NRS) (0–10; 0 = no pain, 10 = worst imaginable pain)
Timepoint [1] 333932 0
24 Hours post operative
Secondary outcome [2] 334801 0
Pain score at movement of the ipsilateral arm
pain score will be assessed using the numerical rating scale (NRS) (0–10; 0 = no pain, 10 = worst imaginable pain)
Timepoint [2] 334801 0
24 Hours post operative
Secondary outcome [3] 334802 0
intraoperative fentanyl requirements recorded from the anesthetic chart
Timepoint [3] 334802 0
time of surgery
Secondary outcome [4] 334803 0
Any side effect (Nausea,Vomiting ,etc) reported in the patient notes
Timepoint [4] 334803 0
24 hours post operative

Eligibility
Key inclusion criteria
Patients American Society of Anesthesiologists (ASA) classification score 1 to 3 scheduled for modified radical mastectomy
Minimum age
18 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
patients with history of advanced cardiac disease or having sepsis, Those with prior surgery in areas above or below the clavicle or in the axillary region, Those with opioid dependence or alcohol or drug abuse, those with coagulopathy p, and those with psychiatric illness that prevent them from proper perception and assessment of pain,

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 90 patients will be randomly assigned into 3 groups (30 patients each) using a randomization –computer program and to conceal the allocation the method of sealed envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The 90 patients will be randomly assigned into 3 groups (30 patients each) using a randomization –computer program and to conceal the allocation the method of sealed envelope
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
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
80% power of detecting difference at 0.05 level of significance using a confidence interval of 95% was obtained by calculating sample size of 30 patients patients per group giving a total target of 90 patients to enforce the study.
Statistical analysis will be performed using SPSS version17.0. One-way ANOVA will be used to compare mean age , weight, baseline hemodynamics, duration of anesthesia and surgery, total morphine consumption, time for first analgesic rescue , and intraoperative fentanyl requirements among the three groups. A value of p < 0.05 will be considered statistically significant. Pearson’s chi-squared or Fisher’s exact test will be used to compare the need for rescue analgesics, satisfaction score and side effects. Repeated measures ANOVA will be used to perform inter-group comparisons for HR, BP and NRS. Post hoc analysis was performed with Tukey’s test. Kruskal–Wallis will be applied to compare sedation scores among the three groups. If found significant, then pairwise Mann–Whitney test will be applied as a post hoc test and a p value < 0.02 will be considered significant due to the Bonferroni correction.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
20/06/2017
Actual
Date of last participant enrolment
Anticipated
20/07/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment outside Australia
Country [1] 8828 0
Saudi Arabia
State/province [1] 8828 0

Funding & Sponsors
Funding source category [1] 296226 0
Hospital
Name [1] 296226 0
Ain Shams University Hospital
Country [1] 296226 0
Egypt
Primary sponsor type
Individual
Name
Amira Soliman
Address
, Faculty of Medicine, Ain Shams University, Abbassyia 11566, Cairo, Egypt
Country
Egypt
Secondary sponsor category [1] 295406 0
None
Name [1] 295406 0
Address [1] 295406 0
Country [1] 295406 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297465 0
Saudi German Hospitals ethical committee and institutional review board
Ethics committee address [1] 297465 0
King Fahad Branch Road, As Sahafah, Riyadh 13321, Saudi Arabia
Ethics committee country [1] 297465 0
Saudi Arabia
Date submitted for ethics approval [1] 297465 0
11/01/2017
Approval date [1] 297465 0
14/03/2017
Ethics approval number [1] 297465 0

Summary
Brief summary
Significant postoperative pain can follow major surgical procedures for cancer breast . postoperative pain that not well controlled has a lot of negative consequences as the patient sufferings, more hospital costs with extended hospital stay, and it is a risk factor in the development of chronic post-mastectomy pain .Procedural interventions involving regional blocks are found to be more effective than pharmacologic means .Pecs 1 and 2 can provide effective postoperative analgesia for such procedures . Pecs 1 and 2 blocks are field blocks that aim to deposit the local anesthetic between the pectoralis major and minor muscles and between pectoralis minor and serratus anterior respectively to block the different peripheral nerves supplying breast and so providing complete analgesia for breast surgery . Dexmetomedine an alpha2 receptor agonist has been used as an adjuvant to local anesthetic for various regional anesthetic techniques with significant prolongation of duration of analgesia . Ketamine a N-methyl-D-aspartate receptor antagonist has a reported local anesthetic and analgesic properties .Studies on caudal administration of ketamine combined with the local anesthetic has shown that it is effective for prolonging the duration of postoperative analgesia. Very few studies about the efficacy of ketamine for prolonging the duration of analgesia when combined with local anesthetic for peripheral nerve blocks with different conclusions.
Therefore our study was planned to compare the analgesic efficacy and safety of ultrasound guided Pecs 1 and 2 blocks with local bupivacaine versus bupivacaine added to either ketamine or dexmetomidine in patients undergoing breast cancer surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74126 0
Dr Amira soliman
Address 74126 0
Department of anaesthesia.Faculty of Medicine, Ain Shams University, Abbassyia 11566, Cairo, Egypt
Country 74126 0
Egypt
Phone 74126 0
+20 01 273046528
Fax 74126 0
Email 74126 0
[email protected]
Contact person for public queries
Name 74127 0
Dr Ahmad shaaban
Address 74127 0
Department of anaesthesia.Faculty of Medicine, Ain Shams University, Abbassyia 11566, Cairo, Egypt
Country 74127 0
Egypt
Phone 74127 0
+20 01 005280883
Fax 74127 0
Email 74127 0
[email protected]
Contact person for scientific queries
Name 74128 0
Dr AHMAD SHAABAN
Address 74128 0
Department of anaesthesia.Faculty of Medicine, Ain Shams University, Abbassyia 11566, Cairo, Egypt
Country 74128 0
Egypt
Phone 74128 0
+20 100 5280883
Fax 74128 0
Email 74128 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
withdrawn


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.