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CTRI Number  CTRI/2022/02/040346 [Registered on: 16/02/2022] Trial Registered Prospectively
Last Modified On: 15/02/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   The Comparison Of Two Fascial Plane Blocks For Post Operative Analgesia In Abdominal Surgeries. 
Scientific Title of Study   The Comparative Evaluation Of Ultrasound Guided Quadratus Lumborum And Erector Spinae Block For Post Operative Analgesia In Abdominal Surgeries. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Divya Gupta 
Designation  Professor  
Affiliation  Himalayan Institute Of Medical Sciences 
Address  Department of Anaesthesia,Pain Management and Critical Care. Himalayan Institute Of Medical Sciences,Swami Rama Himalayan University,Jolly Grant.

Dehradun
UTTARANCHAL
248140
India 
Phone  9456570288  
Fax    
Email  divyagupta@srhu.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manjot Kaur Ahluwalia 
Designation  Post Graduate Resident 
Affiliation  Himalayan Institute Of Medical Sciences 
Address  Department of Anaesthesia,Pain Management and Critical Care. Himalayan Institute Of Medical Sciences,Swami Rama Himalayan University,Jolly Grant.

Dehradun
UTTARANCHAL
248140
India 
Phone  8437973351  
Fax    
Email  manjotkaur0194@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Manjot Kaur Ahluwalia 
Designation  Post Graduate Resident 
Affiliation  Himalayan Institute Of Medical Sciences 
Address  Department of Anaesthesia,Pain Management and Critical Care. Himalayan Institute Of Medical Sciences,Swami Rama Himalayan University,Jolly Grant.

Dehradun
UTTARANCHAL
248140
India 
Phone  8437973351  
Fax    
Email  manjotkaur0194@gmail.com  
 
Source of Monetary or Material Support  
Department Of Anaesthesia,Pain Management and Critical Care Himalayan Institute Of Medical Sciences,Swami Rama Himalayan University,Jolly Grant 
 
Primary Sponsor  
Name  Himalayan Institute Of Medical Sciences 
Address  Himalayan Institute Of Medical Sciences,Swami Rama Himalayan University,Jolly Grant,Dehradun 
Type of Sponsor  Private 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 Manjot Kaur Ahluwalia  Himalayan Institute Of Medical Sciences  Induction Room, Pre op area, Operation Theatre first floor, Department of Anaesthesia ,Himalayan Institute Of Medical Sciences,Swami Rama Himalayan University, Jolly Grant
Dehradun
UTTARANCHAL 
8437973351

manjotkaur0194@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K638||Other specified diseases of intestine,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1)Age - 18-65 Years
2)Gender– Both male and female patient
3)Physical Status :American Society of Anesthesiologists (ASA) I and II patients
scheduled to undergo upper abdominal surgeries with midline incision
 
 
ExclusionCriteria 
Details  1)American Society of Anaesthesiologists(ASA) physical status more than or equal to III patients
2)Local infection at the site of block
3)H/o allergy to study medications
4)Patients on chronic pain relief medications
5)Allergic to local anesthetics
6)Bleeding disorders
7)Dyselectrolytemias
8)Patient on anti-coagulants
9)Inability to give informed consent
10)Severe cardiovascular , respiratory, liver and kidney disease
11)Patient who cannot operate Patient Controlled Analgesia (PCA) system
12)Psychiatric disorders
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To observe and evaluate post operative analgesic efficacy of ultrasound guided Bilateral Quadratus Lumborum block and Bilateral Erector Spinae block in abdominal surgeries with midline incision.  To observe the total post operative fentanyl consumption over 24 hrs after administration of each block in either group and to study pain intensity at 0,4,8,12,16,20 and 24 hrs intervals respectively.  
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcome variable will be Motor block.It will be evaluated using modified Bromage Score.  It will be calculated at time points 0,4,8,12,16,20 and 24 h after anesthesia recovery. 
 
Target Sample Size   Total Sample Size="67"
Sample Size from India="67" 
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)   16/02/2022 
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   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The International Association for the Study of Pain (IASP) defines pain as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage”.

Post-operative pain is a problem for many patients and affects recovery, risk of post-operative complications and quality of life. A thorough preoperative evaluation, careful perioperative planning, identification, and individualized treatment of high-risk patients can reduce post-operative pain. Multimodal treatment combines different analgesic techniques in order to utilize synergistic and additive effects of different treatments and has the potential to optimize effects and reduce side effects.

Currently, various modalities for post-operative pain management exist. Traditionally opioids ,NSAIDS and Paracetamol were used as the main agents for post-operative analgesia.Newer modalities include Patient Control Analgesia (PCA) pumps, epidural neuraxial blocks and peripheral nerve blocks. With multimodal approach there is decrease in opioid requirement and at the same time reduction in side effects due to opioids such as nausea, vomiting, drowsiness and constipation.

There is an increasing trend toward the use of peripheral nerve blocks for post-operative pain control. They are one of the safest and most effective methods to control pain from surgery.For post- operative pain control nerve blocks can be given alone or as a component of multimodal analgesia. In a peripheral nerve block, anaesthetic drug is injected at a particular site around the nerves which then stop the pain signal to reach the brain, thus provides analgesia. Peripheral nerve block can be given as a single injection (sPNB), when post-operative pain is of short duration or as a continuous catheter infusion (cPNB), when prolonged post-operative analgesia is required .

Uncontrolled pain after abdominal surgery increases the incidence of postoperative complications, as it prolongs hospitalization, and increases health care costs and the use of opioids.Interfacial plane blocks such as Quadratus Lumborum block (QLB) and Errector Spinae block are the new emerging modalities, performed by ultrasound guidance, that are being put to use for post operative analgesia in patients undergoing abdominal surgeries.

Quadratus lumborum block has been used for postoperative analgesia in patients undergoing upper abdominal surgeries. The analgesia is achieved in T7–L1 dermatomes,with cranial spread to T4–T5 and caudal spread to L2–L3 dermatomes. Quadratus lumborum block 3 implies the application of the local anesthetic between the QLM and the psoas major muscle (PMM) at the front of the QLM, at the level of its attachment to the transverse process of L4 vertebra.

Erector spinae block (ESB) is an interfascial plane block in which anaesthetic drug is injected between anterior surface of Erector spinae muscle and transverse process of underlying vertebra. It acts by blocking dorsal and ventral rami of spinal nerves .Block will be performed at the T9 level in our study.

Ropivacaine is a long-acting amide local anaesthetic agent and first produced as a pure enantiomer .It produces effects similar to other local anaesthetics via reversible inhibition of sodium ion influx in nerve fibres. Ropivacaine is less lipophilic than bupivacaine and is less likely to penetrate large myelinated motor fibres, resulting in a relatively reduced motor blockade.Thus, ropivacaine has a greater degree of motor sensory differentiation, which could be useful when motor blockade is undesirable. The reduced lipophilicity is also associated with decreased potential for central nervous system toxicity and cardiotoxicity.

Patient controlled analgesia (PCA) is another modality which is given along with    peripheral nerve blocks to reduce post-operative pain. PCA allow patient to control his desired level of analgesia which ultimately lead to patient satisfaction .

The above mentioned nerve blocks have been studied and used in the management of postoperative pain in patients undergoing upper abdominal surgeries with variable results. So, in this study we will be comparing the effectiveness of Quadratus lumborum block and Erector spinae plane block along with PCA for post-operative pain management in abdominal surgeries with midline incision.

Sample Size:

n= (Z2a/2 p(1-p)

              d2

Z α/2 = 1.96 at 5% level of significance

p = prevalence

Here, we conside p=50%

p=505=0.5

1-p=1-0.5=0.5

d=adsolute pricisim

d=12%=0.12

n= (1.96)2x(0.5)x(0.5)

              (0.12)2

n= 3.84x0.25

        0.0144

n=66.66

n = 67

So, the sample size is 67.

 

 

 


 
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