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CTRI Number  CTRI/2019/12/022389 [Registered on: 16/12/2019] Trial Registered Prospectively
Last Modified On: 14/12/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of two drugs in post operative pain management in breast surgeries 
Scientific Title of Study   “COMPARATIVE EFFICACY OF LEVOBUPIVACAINE AND ROPIVACAINE IN ULTRASOUND GUIDED SERRATUS ANTERIOR PLANE BLOCK FOR PATIENTS UNDERGOING UNILATERAL BREAST SURGERIES: A RANDOMIZED CONTROLLED TRIAL 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Krishna Rathod 
Designation  Junior resident 
Affiliation  Vijayanagar institute of medical sciences, Ballari 
Address  Department of anesthesiology Vijayangar institute of medical sciences, Ballari 583 104

Bellary
KARNATAKA
583 104
India 
Phone  9901170297  
Fax    
Email  krishnarathod114@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bala Subramanya H 
Designation  Professor 
Affiliation  Vijayanagar institute of medical sciences, Ballari 
Address  Department of anesthesiology Vijayangar institute of medical sciences, Ballari 583 104

Bellary
KARNATAKA
583 104
India 
Phone  9980600724  
Fax    
Email  halsanadu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Krishna Rathod 
Designation  Junior resident 
Affiliation  Vijayanagar institute of medical sciences, Ballari 
Address  Department of anesthesiology Vijayangar institute of medical sciences, Ballari 583 104

Bellary
KARNATAKA
583 104
India 
Phone  9901170297  
Fax    
Email  krishnarathod114@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Vijayanagar institute of medical sciences 
Address  Department of anesthesiology Vijayangar institute of medical sciences, Ballari 583 104 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Krishna Rathod  Vijayangar institute of medical sciences, Ballari 583 104  Department of anesthesiology Vijayangar institute of medical sciences, Ballari 583 104
Bellary
KARNATAKA 
9901170297

krishnarathod114@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
VIMS institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: R20-R23||Symptoms and signs involving the skin and subcutaneous tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  INJ LEVOBUPIVACAINE BY ULTRASOUND GUIDED SERRATUS ANTERIOR PLANE BLOCK  Single bolus dose of 30ml of 0.5% INJ LEVOBUPIVACAINE, IS ADMINISTERED BY ULTRASOUND GUIDANCE FOR SERRATUS ANTERIOR PLANE BLOCK, followed by general anaesthesia FOR PATIENTS UNDERGOING UNILATERAL BREAST SURGERIES 
Comparator Agent  INJ ROPIVACAINE BY ULTRASOUND GUIDED SERRATUS ANTERIOR PLANE BLOCK  Single bolus dose of 30ml of 0.5% INJ ROPIVACAINE IS ADMINISTERED BY ULTRASOUND GUIDANCE FOR SERRATUS ANTERIOR PLANE BLOCK, followed by general anaesthesia FOR PATIENTS UNDERGOING UNILATERAL BREAST SURGERIES 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  ASA physical status I & II patients
Female patients in the age group of 18 to 65 years.
Patients posted for elective unilateral breast surgeries with or without axillary clearance under general anaesthesia. 
 
ExclusionCriteria 
Details  Refusal by patients for the block.
Surgery duration more than 2 hours.
History of significant systemic disorders (cardiovascular, respiratory,
central nervous system or renal system).
Infection at block site of block.
Thoracic wall and chest wall deformities.
Allergy to the study drugs. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the duration of postoperative analgesia  Study parameters are observed and recorded just before the administration of block, 5 minutes after administration, at the time of skin incision and every 10 minutes intra-operatively following the block till extubation and post-operatively at 5 min, 15min, 30min, then hourly for first 2 hours and at 4,6,12,24hrs after extubation. Post-operative pain will be assessed using visual analog scale (VAS) at rest and at coughing. Inj.tramadol 50 mg IV is used as rescue analgesic when VAS score is 4. 
 
Secondary Outcome  
Outcome  TimePoints 
the need for rescue analgesic,
total dose of rescue analgesic required,
perioperative haemodynamics
incidence of post-operative nausea and vomiting (PONV) and
adverse effects, if any. 
Up to 24hrs after extubation 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/12/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Breast cancer is increasingly becoming the most common cancer among the females in India.  It accounts to around 25-32% of all female cancers in India as per National Cancer Registry1. Advances in Oncology has led to effective treatment in breast cancers.

 

Breast cancers requires various surgical interventions like lumpectomy or mastectomy with axillary lymph node clearance. General anaesthesia is the conventional, most frequently used anaesthetic technique. Various regional anaesthetic techniques interventions have also been used for breast surgeries; these include local infiltration, thoracic epidural anaesthesia, thoracic  paravertebral blocks, thoracic spinal anaesthesia, and more recently, ultrasound guided interfascial plane blocks such as Pectoral nerves ( PECS ),  type 1 and  type 2, Serratus anterior plane block. Although the beneficial effect of regional anaesthesia is well known, data are emerging for other potentially beneficial effects of regional anaesthesia and analgesia on other perioperative outcomes. Those include decreased need of opioid analgesics for post-operative pain management, decreased post-operative nausea and vomiting (PONV).

 

Serratus anterior plane block was described by Fajardo as a new ultrasound guided technique. Local anaesthetic is injected between serratus anterior and external intercoastal muscles in the mid-axillary line to block the lateral cutaneous branches of the intercoastal nerves mainly from T2-T9 before dividing into anterior and posterior branches. On injection of local anesthetic at this level also blocks the thoracic and thoracodorsal nerves.

 

The long-acting local anaesthetics viz., Ropivacaine and Levobupivacaine have been developed after the evidence of bupivacaine-related severe toxicity. Both these agents are pure left-isomers and, based on their three-dimensional structure; they have less toxic potential both on the central nervous system and on the heart.  Although levobupivacaine is theoretically more potent than ropivacaine, clinical studies show conflicting results in terms of anesthetic and analgesic characteristics. Studies on various nerve blocks have shown that equipotent doses of ropivacaine and levobupivacaine have similar efficacy in peripheral nerve plexus blocks2. However, no study is available in the literature comparing the relative efficacy of these drugs in Serratus anterior plane block.

 

This study is conducted to assess the comparative efficacy of Inj. Levobupivacaine and Inj. Ropivacaine in Serratus anterior plane block as a part of  multimodal analgesia inpatients undergoing unilateral breast surgeries under general anaesthesia.

 
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