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CTRI Number  CTRI/2018/11/016374 [Registered on: 16/11/2018] Trial Registered Prospectively
Last Modified On: 15/11/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Breast cancer surgery and postoperative pain management with nerve block 
Scientific Title of Study   COMPARISON OF POSTOPERATIVE ANALGESIC EFFICACY OF ULTRASOUND GUIDED ERECTOR SPINAE BLOCK VERSUS PECTORAL NERVE BLOCK AFTER BREAST SURGERIES: A PROSPECTIVE RANDOMIZED CONTROL 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 Geeta Singariya 
Designation  Professor 
Affiliation  Dr. S.N. medical collage, Jodhpur 
Address  123 vaishali avenue, jhanwar road, Jodhpur
Dept of anesthesiology and critical care, Dr S N Medical college, Jodhpur
Jodhpur
RAJASTHAN
342008
India 
Phone  9414803554  
Fax    
Email  geetamanoj007@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Geeta Singariya 
Designation  Professor 
Affiliation  Dr. S.N. medical collage, Jodhpur 
Address  123 vaishali avenue, jhanwar road, Jodhpur
Dept of anesthesiology and critical care, Dr S N Medical college, Jodhpur
Jodhpur
RAJASTHAN
342008
India 
Phone  9414803554  
Fax    
Email  geetamanoj007@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  DR Himani Pahuja 
Designation  Postgraduate student  
Affiliation  Dr. S.N. medical collage, Jodhpur 
Address  Dept of anesthesiology and critical care, Dr S N Medical college, Jodhpur
Dept of anesthesiology and critical care, Dr S N Medical college, Jodhpur
Jodhpur
RAJASTHAN
342001
India 
Phone  08949038805  
Fax    
Email  himani.dochimani.pahuja6@gmail.com  
 
Source of Monetary or Material Support  
Dr S N Medical College Jodhpur  
 
Primary Sponsor  
Name  NIL 
Address  Not applicable 
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 
DrGeeta Singariya  M D M Hospital  Main OT Complex First floor Dept of Anaesthesia MDM hospital Dr. S.N. medical collage Jodhpur
Jodhpur
RAJASTHAN 
9414803554

geetamanojkamal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr S N Medical College Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group E (Erector spinae plane block )  Patients will receive ESP block using 20 ml of 0.25% levobupivacaine 
Comparator Agent  Group P (Pectoral Block)  Patients will receive PECS block using 30 ml of 0.25% levobupivacaine. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  1. Age between 18 to 65 yr.
2. Body weight 40 to 80 kg.
3. Patients belong to American Society of Anaesthesiologists (ASA) grade-I and II.
4. Female patients scheduled for breast surgeries under general anaesthesia.
 
 
ExclusionCriteria 
Details  1. Local infection at the block site.
2. Coagulopathy.
3. Morbid obesity or body mass index (BMI >40).
4. Allergy to local anaesthetics.
5. Decreased pulmonary reserve.
6. Cardiac disorders.
7. Renal dysfunction.
8. Pre-existing neurological deficits. 9. Psychiatric illness.
 
 
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 post-operative rescue analgesic (morphine) consumption in first 24 hours.
 
24 hours.
 
 
Secondary Outcome  
Outcome  TimePoints 
ï‚§To compare the duration of analgesia (time to first rescue analgesia after administration of block)
ï‚§ To compare Pain scores in first 24 h.
ï‚§ Hemodynamic monitoring in first 24 h.
 Patient’s satisfaction score.
ï‚§ Any complications / adverse effects/side effects of block.

 
24 hours 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   26/11/2018 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This prospective, randomized study will be conducted in the Department of Anaesthesiology, Dr. S. N. Medical College and Attached Group of Hospitals, Jodhpur. The patients will be randomly selected from the patients posted for elective modified radical mastectomy, under general anaesthesia after confirming all inclusion and exclusion criteria. A written informed consent will be taken from all the patients for performance of block after complete explanation about the study protocol, anaesthetic technique, merits and demerits of the procedure in perioperative course of anaesthesia.

Preoperative evaluation and preparation: All selected patients will be undergo a routine pre-anaesthetic check-up (PAC), including explanation of numeric rating scale (NRS) [19] pain scale (0-10, where 0 stands for no pain and 10 stands for worst imaginable pain) for post-operative pain assessment. All the patients will be kept nil per oral as per the fasting guidelines. All patients will be premedicated with tab alprazolam 0.5 mg orally night before the surgery.  In the operative room, identification of patient, fasting status, consent and PAC will be confirmed. After reassuring the patient, standard ASA monitoring will be applied. Base line heart rate (HR), non- invasive systolic blood pressure (SBP), diastolic blood pressure (DBP) and mean blood pressure (MAP), respiratory rate (RR), and peripheral oxygen saturation (SpO2) will be recorded. Continuous electrocardiographic (ECG) monitoring will be done. Peripheral i.v. cannulation will be done by using 18G cannula in the contralateral upper limb and lactated ringer’s solution will be started.

Method of ESP block:-The block will be performed on the side of surgery with the technique used by Forero M and colleagues [38]. The patient will be placed in a sitting position and a high frequency linear ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to T3 or 4 spinous process. Trapezius, rhomboid major and erector spinae muscles will be identified, superficial to the hyperechoic transverse process shadow and a 10 cm, 22 G block needle will be inserted until the tip crosses the interfacial plane between rhomboid major and erector spinae muscle, and reaches the transverse process, evidenced by visible linear spread of fluid upon injection. After negative aspiration, 20 ml of 0.25% levobupivacaine will be injected.

Method of Pectoral Block:-In Group P PECS block will be performed on the side of surgery after informed consent and application of standard monitoring. The patient will be placed in supine position with the arm abducted (block side). The area will be prepared with 5% povidone iodine solution and covered with sterile drapes. Skin will be infiltrated with 2% lignocaine. The USG probe will be placed at midclavicular level inferolaterally to locate the axillary artery and vein, and then moved laterally until pectoralis minor and serratus anterior muscles will be identified at 3rd rib level. After identification of muscle layers, the needle will be advanced in the plane of probe from medial to lateral in an oblique manner until the tip enters the plane between pectoralis minor and minor serratus anterior muscle, 20 ml of levobupivacaine deposited. After deposited the drug in between pectoralis minor and serratus anterior muscle, the needle will be withdrawn till it lies in the potential space between pectoralis minor and pectoralis major. After negative aspiration 10 ml of levobupivacaine deposited in this space.

After performing the block, the patients will be observed in pre-operative room for 30 min. The sensory level of block will be assessed with pin prick method every 5 min till 30 min. Total number of dermatomes that has less pain to pin prick compared with opposite side will be noted. If pin prick sensation does not decrease, then it is considered as block failure. Any side effect in form of nausea, vomiting, respiratory depression, hypotension, and pruritus and chest pain will be noted. Respiratory depression is defined as respiratory rate less than 8 breath/min or SpO2 <90% after 30 min of block, patient will be shifted to the operating room.

Anaesthesia technique:-The general anaesthesia will be induced with injection fentanyl (2 μg/kg) and propofol (1.5 mg/kg). The endotracheal intubation will be facilitated by using muscle relaxant inj. vecuronium bromide (0.1mg/kg) after confirming adequacy of ventilation and loss of consciousness. The airway will be secured with appropriate size of endotracheal tube. The anaesthesia will be maintained with air oxygen (50:50), isoflurane and injection vecuronium bromide. Supplemental analgesia will be providing with injection fentanyl (1 μg/kg) when rise in HR or MAP more than 20% of base line values. 

Continuous monitoring of HR, NIBP, SpO2 and end tidal carbon-dioxide (EtCO2) will be done throughout intra operative period and recorded every 15 min. The EtCO2 will be maintained between 35-40 mm Hg. The number of doses and total amount of supplement analgesia intra operative with fentanyl will be recorded for comparison between two groups. Fifteen min before surgery completion ondansetron 8 mg i.v. given and residual neuromuscular blockade will be reversed with neostigmine 0.05 mg/kg and glycopyrrolate 0.01 mg/kg i.v. and the trachea will be extubated when the patient is fully awake and breathing adequately. The patients will be shifted to the recovery room for further management. The total duration of the surgery will be also recorded.

Post operatively patients will be given morphine 3 mg i.v. as rescue analgesia, if NRS ≥4.  HR, NIBP, SpO2, RR and NRS score will be recorded at 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 and 24 h after the surgery. Time to first rescue analgesia as well as the total doses of morphine used in first 24 h will be recorded. Any side effects like nausea, vomiting, respiratory depression, hypotension, pruritus and chest pain will be recorded and will be treated accordingly. The patient’s satisfaction score will be noted. Nausea lasting more than 10 min or vomiting will be treated with ondansetron 4mg i.v.

Postoperative observations:-

The following characteristics of the block will be observed postoperatively:

1. Duration of analgesia: Duration of analgesia will be defined as the time interval from completion of local anesthetic administration till first need of rescue analgesic. The rescue analgesic regime morphine 3 mg i.v. slowly as analgesic whenever NRS ≥ 4 or on request.

 2. Pain assessment: The numerical rating scale (NRS) is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0–10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line which contains 11-point numeric scale ranges from ’0’ representing one pain extreme (e.g. “no pain”) to ’10’ representing the other pain extreme (e.g. “pain as bad as you can imagine” or “worst pain imaginable”). NRS for pain will be assessed during rest (NRS-R) and movement (NRS-M) at predefined intervals at 0, 2, 4, 6, 8, 10, 12, 15, 18, 21 and 24 h postoperatively. 

3. Total rescue analgesic consumption: The total dose of morphine used in initial 24 h.

4. Postoperative side effects or complications: Local anesthetic toxicity, nausea, vomiting, pruritus, drowsiness, convulsions etc.

 5. Hemodynamic and respiratory changes: Bradycardia (pulse <50 beats/min), hypotension (reduction of MAP >20% of baseline), respiratory depression (RR ≤8 breaths/minute or SpO2< 90%).

 6. Patient’s satisfaction score:    4 = excellent, 3 = good, 2 = fair, 1 = poor.

  


 
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