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CTRI Number  CTRI/2017/03/008134 [Registered on: 17/03/2017] Trial Registered Prospectively
Last Modified On: 27/04/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare pain relief provided by either Quadratus lumborum nerve block or Psoas Compartment nerve block in patients undergoing hip replacement surgery under general anaesthesia  
Scientific Title of Study   To compare postoperative analgesia between ultrasound guided continuous Quadratus lumborum block with ultrasound guided continuous Psoas compartment block in patients undergoing total hip arhroplasty under general anaesthesia  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anjolie Chhabra 
Designation  Professor Anaesthesiology 
Affiliation  All India Institute of Medical Sciences, Ansari Nagar, New Delhi 
Address  Department of Anaesthesiology, Room no. 5013, 5th Floor, Teaching block, All India Institute of Medical Sciences, Ansari Nagar,New Delhi

New Delhi
DELHI
110029
India 
Phone  01126546691  
Fax  01126588641  
Email  anjolie5@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arjun Balkrishnan  
Designation  Junior Resident Anaesthesiology  
Affiliation  All India Institute of Medical Sciences, Ansari Nagar, New Delhi 
Address  Department of Anaesthesiology, Room no. 5011, 5th Floor, Teaching block, All India Institute of Medical Sciences, Ansari Nagar,New Delhi

New Delhi
DELHI
110029
India 
Phone  01126593212  
Fax  01126588641  
Email  arj.0007@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anjolie Chhabra 
Designation  Professor Anaesthesiology 
Affiliation  All India Institute of Medical Sciences, Ansari Nagar, New Delhi 
Address  Department of Anaesthesiology, Room no. 5013, 5th Floor, Teaching block, All India Institute of Medical Sciences, Ansari Nagar,New Delhi

New Delhi
DELHI
110029
India 
Phone  01126546691  
Fax  01126588641  
Email  anjolie5@hotmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, New Delhi 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences New Delhi 
Address  Ansari Nagar New Delhi 
Type of Sponsor  Research institution and hospital 
 
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 Anjolie Chhabra  Orthopaedics Operation thetre complex All India Institute of Medical Sciences  Ansari Nagar, New Delhi
New Delhi
DELHI 		 01126546691
01126588641
anjolie5@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Adult patients undergoing total hip arthroplasty, (1) ICD-10 Condition: M16||Osteoarthritis of hip,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  continuous Psoas compartment block   The ultrasound guided continuous Psoas compartment block will be placed with a low frequency (3-5 MHz) transducer. Under strict aseptic precautions first a small amount of local anaesthetic (3-5ml of 2% lignocaine) will be infiltrated in the skin at the site of block. Then a 10cm long 21G stimulating needle will be inserted with an in-plane technique and advanced into the psoas major muscle under ultrasound guidance. (10) Needle position near the lumbar plexus will be confirmed using a nerve stimulator needle which will be used to elicit quadriceps twitch with current between 0.3 to 0.5 amp. A bolus of 0.4ml per kg 0.2% ropivacaine will be injected through the needle. Thereafter a compatible catheter will be threaded over the needle into the space and 2-3 ml 5% dextrose injection used to confirm catheter tip position with ultrasound. A continuous infusion of 0.25% ropivacaine at a rate of 0.1 ml/kg/ hour would be started using an infusion pump. 
Intervention  ultrasound guided continuous Quadratus lumborum block  The continuous trans-muscular QLB will be done using a low frequency (3-5 MHz) transducer. Under strict aseptic precautions first a small amount of local anaesthetic (3-5ml of 2% lignocaine) will be infiltrated in the skin at the site of block. Then a 10cm long 21G stimulating needle will be inserted under ultrasound guidance with an in-plane technique and the tip will be advanced through the quadratus lumborum muscle until it penetrates the ventral fascia of the quadratus lumborum, and reaches the plane between the QL and psoas muscle. 1-2 ml 5%dextrose will be injected to confirm correct needle tip position and to create space following which a bolus of 0.4ml/kg of 0.25% ropivacaine will be injected so as to open up the space. Thereafter a compatible catheter will be threaded over the needle into the space and 2-3 ml 5% dextrose injection used to confirm catheter tip position with ultrasound. A continuous infusion of 0.25% ropivacaine at a rate of 0.1 ml/kg/ hour would be started using an infusion pump 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  60 patients of ASA physical status I to III aged 18 to 70 years undergoing unilateral THA under general anaesthesia at AIIMS, New Delhi 
 
ExclusionCriteria 
Details  1. Patient refusal to participate
2. Those who are unable to denote pain using a VAS scale(0-100mm)
3. Bleeding diasthesis or anticoagulant use
4. Bilateral THA done in the same sitting
5. BMI >30kg/m2
6. Local infection at the site of the proposed 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 
Primary objective: to compare pain scores post-operatively, at rest and on mobilisation using visual analog scale (VAS, 0-100mm) between patients receiving either continuous ipsilateral transmucular QL block or PCB for perioperative analgesia following unilateral total hip arthroplasty under general anaesthesia  6 hours post-operatively  
 
Secondary Outcome  
Outcome  TimePoints 
Sensory dermatomes blocked
 		 30 min following injection preoperatively 
Motor dermatomes blocked  30 min following injection preoperatively and at, 6, 12 and 24 hours post-operatively  
Pain scores at rest using (0-100mm VAS)  at 0, 1, 2, 4, 6, 12 and 24 hours post-operatively 
Pain scores on movement (plantar and dorsal ankle flexion) (0-100mm VAS)  at 0, 1, 2, 4, 6, 12 and 24 hours post-operatively 
Total analgesic requirement  intraoperative and 24 hour postoperative PCA fentanyl and rescue 
Quality of Recovery score  24 hours postoperatively  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="59" 
Phase of Trial   N/A 
Date of First Enrollment (India)   17/04/2017 
Date of Study Completion (India) 28/09/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
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)?  

Brief Summary  

Total hip arthroplasty (THA) is a commonly performed procedure for irreversible hip joint damage. Post-operative analgesia in patients undergoing THA remains a challenge with up to 50% patients undergoing this procedure complaining of severe pain after the surgery.(1) According to a recent meta-analysis currently there is no proven best method of providing post-operative analgesia for these patients.(2) Systemic opioids are routinely used for providing perioperative analgesia for patients undergoing THA, but their use is limited by side effects such as nausea, vomiting, sedation constipation and respiratory depression. All these side effects are especially undesirable as a number of patients undergoing THA are elderly.

In our institute most THAs are performed under central neuraxial block. A combined spinal epidural technique is usually used, a bolus of 10-15mg hyperbaric 0.5% bupivacaine is administered initially in the sub arachnoid space followed by epidural boluses of local anaesthetic as and when required to extend surgical anaesthesia. For providing postoperative analgesia 30-50 mcg/kg epidural morphine in 10 ml normal saline is administered via the epidural catheter every 8 to 12 hourly. The use of epidural morphine in saline avoids the motor block that is caused by epidural local anaesthetics but its use is associated with exaggerated side effects of systemic opioids, as well as unwanted urinary retention and pruritus in 15-30% patients. (3) In addition performing central neuraxial blocks is not possible in all patients necessitating administration of general anaesthesia at times.

Regional anaesthesia techniques such as ipsilateral psoas compartment block (PCB), fascia iliaca or femoral nerve block have all been used for providing perioperative analgesia, minimising opioid use and aiding in early mobilisation and rehabilitation of patients undergoing THA. (4-7)

The psoas compartment block is a posterior approach to lumbar plexus block that can anaesthetise the areas supplied by the femoral, obturator and lateral femoral cutaneous nerves. (8) The block was traditionally performed using anatomical landmarks and more recently ultrasound guided PCB has been described by a number of authors. (9, 10) The block was traditionally performed using anatomical landmarks and more recently ultrasound guided PCB has been described by a number of authors. (9, 10) The depth at which the lumbar plexus is present usually varies from 7 to 8.5 cm and it lies between the anterior two third and posterior one third of the psoas muscle at this level. (6) The depth at which the plexus is present and the proximity of the kidney and major vessels in this area makes this a technically challenging block to perform. 

The Quadratus lumborum block (QLB) is a relatively new ultrasound (USG) guided plane block wherein local anaesthetic is deposited between the quadratus lumborum (QL) and adjoining muscles. Various techniques of the block have been described and local anaesthetic is deposited either between QL and internal oblique muscle anteriorly (QLB1) or between QL and latissimus dorsi (QLB2) or in another technique between QL and psoas major muscle posteriorly (QLB3). (12-14) Irrespective of the site of injection it has been postulated that proximal migration of the drug to the ipsilateral paravertebral space occurs, resulting in anaesthesia of nerves emerging from the lumbar intervertebral foramen akin to a lumbar plexus block. However this block is technically simpler to perform than a PCB and may be associated with fewer side effects. A single bolus of local anaesthetic administered in QLB1 as compared to compared to a single bolus femoral nerve block has been shown to reduce opioid requirements in the first 24 hours in patients undergoing hemi- hip arthroplasty following femoral neck fracture.(15) The use of continuous QLB3 has also been found to be effective for providing perioperative analgesia following hip arthroplasty in two cases as reported by Ushima and colleagues. (16) In a cadaveric study, the QLB3 technique or transmuscular approach to QL block as described by Borglum has been demonstrated to result in more consistent spread of dye to the lumbar nerve (L1-3) roots as compared to QLB 1 and QLB 2 techniques. (17)

The hypothesis of this study is that an ipsilateral, continuous transmuscular Quadratus lumborum block would be non-inferior to an ipsilateral continuous Psoas compartment block, both block performed under ultrasound guidance for providing perioperative analgesia in patients undergoing unilateral total hip arthroplasty under general anaesthesia. 

 
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