Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001396415
Ethics application status
Approved
Date submitted
5/09/2016
Date registered
7/10/2016
Date last updated
7/10/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of two ultrasound guided nerve blocks in patients undergoing breast surgery: effects on post-surgery pain.
Scientific title
Comparison of analgesic efficacy of Ultrasound guided Paravertebral block and Serratus Anterior Plane block in patients undergoing Modified Radical Mastectomy
Secondary ID [1] 290099 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pain after breast surgery 300186 0
breast surgery 300187 0
Condition category
Condition code
Cancer 300071 300071 0 0
Breast
Anaesthesiology 300235 300235 0 0
Pain management
Anaesthesiology 300236 300236 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the operation theatre of Safdarjung Hospital, new delhi, general anesthesia will be induced with midazolam 1mg, fentanyl 1.5 mcg/kg, propofol 1- 2 mg/kg and vecuronium bromide 0.1 mg/kg and trachea of the patient will be intubated, Patient will be given either ultrasound guided paravertebral block (n=25) or ultrasound guided serratus anterior plane block (n=25) with 20 ml of 0.5% bupivacaine by a staff anesthesiologist with experience of both the blocks ( more than 50 each).
1. Group SAB:--- Ultrasound guided serratus anterior plane block-
This block will be given in supine position. Linear transducer (8-13Mhz) probe of ultrasound machine (Sonosite M-Turbo, Sonosite Inc., USA) will be placed in mid-clavicular region of thoracic cage in the sagittal plane. The latissimus dorsi, teres major and serratus anterior muscles will be identified between 4th and 5th rib. The fascial plane between serratus anterior muscle and latissimus dorsi muscle will be identified. 20 G sonosonic needle will be introduced in-plane with respect to ultrasound probe from superio-anterior to posterio-inferior direction. Under continuous ultrasound guidance, 20ml of 0.5% bupivacaine will be injected superior to the serratus anterior muscle.

Group PVB: Ultra sound guided paravertebral block---
This block will be given in the lateral position. The transducer (linear, 38mm, high frequency 8-13MHz) probe of ultrasound machine (Sonosite M-Turbo, Sonosite Inc., USA) will be placed parallel to the spine, above the transverse process of T4 vertebrae and T5 vertebrae. The thoracic paravertebral space will be identified as a wedge shaped hypoechoic space between internal intercostal membrane and pleura. 20 G sonosonic needle will be inserted in an out of plane approach and advanced under ultrasound guidance until the tip penetrates internal intercostal membrane. Hydro-dissection will be used to locate the tip of needle. 20ml of 0.5% bupivacaine will be injected and movement of pleura downwards will be used as confirmation of block.
Anesthesia will be maintained with O2/ N2O/ 0.8-1% Isoflurane. At the end of surgery, . Neostigmine 50 mcg/kg and glycopyrrolate 10 mcg/kg will be given I.V. and trachea extubated. Patient is shifted to PACU for intensive monitoring of vitals.A resident blinded to block will assess the pain relief and adverse effects at regular intervals for next 72 hrs.
Intervention code [1] 295834 0
Treatment: Drugs
Comparator / control treatment
The patients receiving ultrasound guided serratus plane block - control group
Control group
Active

Outcomes
Primary outcome [1] 299542 0
Primary outcome is post-operative morphine consumption in first 24 hrs post surgery. All observations intra-operatively and post-operatively will be made by a resident, who will be blinded to the type of block given to patient. .Postoperative analgesia will be provided using Patient Controlled Analgesia pump (PCA- T34L, Caesarea Medical Electronics, Israel), attached to the patient in the immediate post operative period. The pump settings will be – morphine- 1 mg/ml; bolus dose 1mg, lock out time 15 mins and maximum dose allowed will be 4mg/hr. Patient will be instructed to use PCA pump whenever she has pain with VAS score greater than 4. PCA pump has a memory that stores the morphine administered to patient
Timepoint [1] 299542 0
The amount of morphine administered to the patient in first 24hrs post-surgery by PCA pump will be recorded by the resident.
Primary outcome [2] 299712 0
Duration of the block- Patient will be instructed to note the first time she uses PCA pump for pain relief on a patient diary. That will be rescue analgesia time
Timepoint [2] 299712 0
Rescue analgesia time- Time between the administration of block to the first use of the PCA pump by the patient will be recorded as the duration of analgesia of the block
Secondary outcome [1] 327475 0
Pain will be assessed by the patients themselves using self rating VAS ranging from 0 (pain free) to 10 (worst imaginable pain). This VAS score will be explained to the patient before surgery.
Timepoint [1] 327475 0
VAS score will be assessed at 4 hrs, 6hrs, 24 hrs, 48 hrs and 72 hrs after block administration and recorded by the resident, who is blinded to the study
Secondary outcome [2] 327928 0
Resident will assess the patient for any adverse effects like nausea, vomiting, respiratory problem and itching.
Timepoint [2] 327928 0
assessment for any adverse effects like nausea, vomiting, respiratory problem and itching will be done at 4 hrs, 6 hrs, 24 hrs, 48 hrs and 72 hrs.
Secondary outcome [3] 328206 0
morphine consumption by patient in first 48 hrs and 72 hrs postsurgery using the PCA pump will be recorded as secondary outcome
Timepoint [3] 328206 0
The amount of morphine administered to the patient in first 48hrs and 72 hrs post-surgery by PCA pump will be recorded by the resident.

Eligibility
Key inclusion criteria
. Female patients aged 18-65 years, who are scheduled to undergo Modified Radical Mastectomy, with ASA physical status I and II and weighing 40-85 kgs.
Minimum age
18 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Contraindications to block (e.g. patient with coagulopathy or taking anticoagulant medication and local infection at the site of block) or recent neurological deficit.
2. Known allergy to local anesthestic.
3. Cardiac, renal, hepatic or respiratory insufficiency.

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 receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/09/2016
Date of last participant enrolment
Anticipated
21/12/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 8195 0
India
State/province [1] 8195 0
delhi

Funding & Sponsors
Funding source category [1] 294467 0
Hospital
Name [1] 294467 0
safdarjung hospital
Country [1] 294467 0
India
Primary sponsor type
Hospital
Name
safdarjung hospital
Address
Safdarjung hospital, Ring Road, New Delhi, Delhi, India -110029
Country
India
Secondary sponsor category [1] 293333 0
None
Name [1] 293333 0
Address [1] 293333 0
Country [1] 293333 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295897 0
vardhaman mahavir medical college & safdarjung hospital ethics committee
Ethics committee address [1] 295897 0
Vardhaman Mahavir Medical College and Safdarjung hospital, Ring Road, New Delhi, Delhi, India -110029
Ethics committee country [1] 295897 0
India
Date submitted for ethics approval [1] 295897 0
01/03/2016
Approval date [1] 295897 0
16/05/2016
Ethics approval number [1] 295897 0
IEC/508

Summary
Brief summary
Introduction: Modified Radical Mastectomy (MRM) may be associated with severe post-operative pain, leading to impairment of respiratory gas exchange or chronic pain syndrome. We will compare the analgesic efficacy and safety profile of two new and promising ultrasound guided nerve blocks: paravertebral block and serratus anterior plane block for these surgeries.
Methods: This study will be conducted on 50 adult females,scheduled for Modified Radical Mastectomy. After inducing general anesthesia,patients will be given either ultrasound guided paravertebral block (n=25) or serratus anterior plane block (n=25) with 20 ml of 0.5% bupivacaine to freeze the nerves. After completion of surgery, patient will be monitored in recovery for adequate pain relief and any adverse effects of the block. Patient will be attached to a I.V.PCA pump for morphine administration, whenever she has pain. The resident will assess the adequacy of pain relief and any side effects at regular intervals.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68846 0
A/Prof dr kapil gupta
Address 68846 0
Associate professor, vardhaman mahavir medical college and safdarjung hospital, Ring Road,New Delhi, Delhi, India- 110029
Country 68846 0
India
Phone 68846 0
+91-9811859019
Fax 68846 0
Email 68846 0
[email protected]
Contact person for public queries
Name 68847 0
A/Prof dr kapil gupta
Address 68847 0
Associate professor, vardhaman mahavir medical college and safdarjung hospital, Ring Road,New Delhi, Delhi, India- 110029
Country 68847 0
India
Phone 68847 0
+91-9811859019
Fax 68847 0
Email 68847 0
[email protected]
Contact person for scientific queries
Name 68848 0
A/Prof dr kapil gupta
Address 68848 0
associate professor, vardhaman mahavir medical college and safdarjung hospital, new delhi- 110029
Country 68848 0
India
Phone 68848 0
+91-9811859019
Fax 68848 0
Email 68848 0
[email protected]

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Results publications and other study-related documents

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