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CTRI Number  CTRI/2022/05/042394 [Registered on: 06/05/2022] Trial Registered Prospectively
Last Modified On: 18/11/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   After Total hip replacement surgery measures of pain relief are compared between two nerve blocks : Erector spinae plane block vs Quadratus lumborum block 
Scientific Title of Study   Comparison Of Ultrasound Guided Erector Spinae Plane Block And Anterior Quadratus Lumborum Block For Post Operative Analgesia In Total Hip Replacement surgery - A Prospective, Randomised, Double blinded Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Paridhi Jain 
Designation  Secondary DNB Postgraduate 
Affiliation  Ganga Medical Centre and Hospital  
Address  Ganga Medical Centre and Hospital 313, Mettupalayam road, Coimbatore, TamilNadu

Coimbatore
TAMIL NADU
641043
India 
Phone  9660045494  
Fax    
Email  drparidhi15@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr J Balavenkatasubramanian 
Designation  Senior Consultant  
Affiliation  Ganga Medical Centre and Hospital 
Address  Ganga Medical Centre and Hospital 313, Mettupalayam road, Coimbatore, TamilNadu

Coimbatore
TAMIL NADU
641043
India 
Phone  9842245757  
Fax    
Email  drbalavenkat@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr J Balavenkatasubramanian 
Designation  Senior Consultant  
Affiliation  Ganga Medical Centre and Hospital 
Address  Ganga Medical Centre and Hospital 313, Mettupalayam road, Coimbatore, TamilNadu

Coimbatore
TAMIL NADU
641043
India 
Phone  9842245757  
Fax    
Email  drbalavenkat@gmail.com  
 
Source of Monetary or Material Support  
Ganga Medical Centre and hospital  
 
Primary Sponsor  
Name  Dr Paridhi Jain 
Address  Ganga Medical Centre and Hospital 313, Mettupalayam road, Coimbatore, TamilNadu 
Type of Sponsor  Other [Self] 
 
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 Paridhi Jain  Ganga Medical Centre and Hospital  Department of Anaesthesiology, Division of Anaesthesia and Perioperative Care
Coimbatore
TAMIL NADU 		 9660045494

drparidhi15@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: M161||Unilateral primary osteoarthritisof hip,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ERECTOR SPINAE PLANE BLOCK  Under Ultrasound Guidance, 25cc of 0.2%Ropivacaine + 8mg Dexamethasone will be injected in plane between tip of transverse process of L4 and deep to Erector Spinae muscle using 23G Nerve stimulating needle. Total duration of analgesia provided by the block will be less than or equal to 24 hours. Patients will be monitored for a period of 24 hours after block administration. 
Comparator Agent  QUADRATUS LUMBORUM BLOCK  Under USG guidance, 25cc of 0.2%Ropivacaine + 8mg Dexamethasone will be injected between Quadratus Lumborum muscle and Psoas major muscle using 23G Nerve Stimulating Needle. Total duration of analgesia provided by the block will be less than or equal to 24 hours. Patients will be monitored for a period of 24 hours after block administration. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  ASA I, II & III
Patient undergoing Total Hip Replacement surgery 
 
ExclusionCriteria 
Details  Patient not willing for surgery
Patient allergic to Local Anesthetic agents
Bleeding diathesis , patient on anti platelets
Revision Surgery
Patient with Hepatic or Renal Failure
Body Mass Index more than 40
Patient having pre-existing Peripheral Neuropathy
Patient on regular opioids prior to surgery
Localised infection at site of Peripheral Nerve block 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Post operative pain score using Numeric Rating Scale  at 30 minutes to 24 hours post operatively 
 
Secondary Outcome  
Outcome  TimePoints 
Time interval of motor activity restoration after administered block  At 30 minutes to 24 hours post operatively 
Quadriceps weakness due to block causing delay in full motor recovery  At 30 minutes to 24 hours post operatively 
Presence of complications like PONV or hypotension  At 30 minutes to 24 hours post operatively 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/05/2022 
Date of Study Completion (India) 18/08/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 18/08/2022 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  
In this study, “COMPARISON OF ULTRASOUND GUIDED ERECTOR SPINAE PLANE
BLOCK AND QUADRATUS LUMBORUM BLOCK FOR POSTOPERATIVE ANALGESIA IN
TOTAL HIP REPLACEMENT SURGERY – A PROSPECTIVE, RANDOMIZED, DOUBLE
BLINDED STUDY”, the analgesic efficacy of ultrasound guided erector spinae plane block and quadratus
lumborum block, as part of multimodal analgesia, will be compared using single shot
0.2% Ropivacaine (25cc) plus Dexamethasone (8mg), following total hip replacement surgery. 70 patients undergoing elective THR
surgery will be included according to the inclusion and exclusion criteria.

Primary objectives:
To determine and compare the analgesic efficacy and duration of analgesia with Lumbar
ESP block and Anterior QL block using Numeric Rating Scale in patients undergoing THR.

Secondary objectives:
1) Time interval after which motor activity will be restored postoperatively and if patients
develop any quadriceps weakness due to the administered block causing delay in
full motor recovery and mobilization.
2) Occurrence of complications like postoperative nausea and vomiting or
hypotension.

Methodology:
Study design: Randomised, double blinded, comparative, prospective study
Place of study: This study will be done in Orthopaedic high dependency unit (HDU) under
department of anaesthesiology in Ganga Medical Centre and Hospital, Coimbatore
Duration of study: 15/04/2022 to 30/06/2022
Sample size: 70 patients, 35 in each group
Study sample: 70 candidates from general population aged 18 to 90 years belonging to either
sex and belonging to ASA I, II or III who will come to our hospital for total hip replacement
and meet the inclusion criteria will be selected for the study.
Patient will be undergoing THR surgery under combined spinal and epidural anaesthesia and they will be
randomised into study groups - Group A (Lumbar-ESPB) and Group B (Anterior-QLB).

After noting the baseline parameters (height, weight, heart rate, blood pressure, saturation), the respective block will be given in the same
lateral position after completion of surgery inside the operation theatre, following which the
patient will be monitored for the next 24 hours. Patient will be followed up at 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8
hr,10 hr,12 hr,18hr and 24 hr (taking the time of block as 0 hrs) and HR, SBP, DBP, oxygen
saturation, NRS score, rescue analgesia requirement and complications or complaints, if any,
will be charted. We will also note the time for motor recovery from neuraxial blockade in terms of
straight leg raise test to 15 degree and dorsiflexion of foot after the surgery. The data thus
obtained, will be analysed to calculate the mean NRS scores, duration of block, time for first
rescue analgesia requirement, time at which patient was able to do active straight leg raise
and dorsiflexion of foot.
 
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