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CTRI Number  CTRI/2024/09/073782 [Registered on: 11/09/2024] Trial Registered Prospectively
Last Modified On: 26/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison between sodium bicarbonate and dexamethasone as adjuncts to levobupivacaine for post operative analgesia provided by quadratus lumborum block for hip surgery. 
Scientific Title of Study   Comparison between sodium bicarbonate and dexamethasone as adjuncts to levobupivacaine for post operative analgesia, given via ultrasound guided lateral quadratus lumborum block for hip surgery. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mehak Gupta 
Designation  Junior Resident 
Affiliation  UPUMS, Saifai, Etawah 
Address  Department of anaesthesiology and critical care, UPUMS, Saifai, Etawah

Mainpuri
UTTAR PRADESH
206130
India 
Phone  8057159619  
Fax    
Email  mg3171995@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mehak Gupta 
Designation  JUNIOR RESIDENT 
Affiliation  UPUMS, SAIFAI, ETAWAH 
Address  DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE, UPUMS, SAIFAI, ETAWAH

Mainpuri
UTTAR PRADESH
206130
India 
Phone  8057159619  
Fax    
Email  mg3171995@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Prashant Kumar Mishra 
Designation  Professor 
Affiliation  UPUMS, SAIFAI, ETAWAH 
Address  Department of Anaesthesiology and critical care, UPUMS, Saifai, Etawah

Mainpuri
UTTAR PRADESH
206130
India 
Phone  9455677608  
Fax    
Email  drprashant.mishra@yahoo.com  
 
Source of Monetary or Material Support  
Uttar Pradesh University of Medical Sciences, Saifai, Etawah 206130 
 
Primary Sponsor  
Name  Uttar Pradesh University of Medical Sciences 
Address  ROOM 329 Department of anaesthesiology and critical care, UPUMS, Saifai, Etawah 206130 
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 Mehak Gupta  Uttar Pradesh University of Medical Sciences  Department of anaesthesiology and critical care, UPUMS, Saifai, Etawah
Etawah
UTTAR PRADESH 		 8057159619

mg3171995@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, UPUMS, Saifai, Etawah(UP) 206130  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S720||Fracture of head and neck of femur, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Comparison of duration of analgesia provided by levobupivacaine in combination with two adjuvants i.e. sodium bicarbonate vs dexamethasone.  WE will compare the duration of analgesia provided by the two combination of drugs, where first combination of drugs is levobupivacaine with dexamethasone and the second combination of drugs is levobupivacaine with sodium bicarbonate.  
Intervention  Lateral quadratus lumborum block.  We will give lateral quadratus lumborum block immediately post operative to the patients of hip surgery who are operated under subarachnoid block and observe the patient for next 24 hrs for the duration and quality of analgesia. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA physical status 1 and 2.
Elective hip surgery under subarachnoid block. 
 
ExclusionCriteria 
Details  Patients with a history of allergy to drugs used in the study .
Any history of substance abuse .
Body mass index (BMI) ≥30 .
Patients with psychosis/gross neurological disorders. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Duration of analgesia.
2.Quality of analgesia. 		 1.After the block is give we will note the very first time when VAS4 and measure the VAS score at an interval of 4 hours till 24 hours.
2.After the 24 hours from the time block is given we will see the satisfaction score. 
 
Secondary Outcome  
Outcome  TimePoints 
1.Hemodynamic parameters.
2.Total need for rescue analgesia over 24 hours. 		 1.After the block is given till next 24 hours at every 4 hour interval.
2.Over 24 hours after the block is given. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   15/09/2024 
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)?  

Response - NO
Brief Summary  
The ideal peripheral nerve block technique for hip arthroplasty should achieve adequate sensory block without affecting motor function. The sensory afferent of the hip joint arise from several branches of lumbar plexus. Ultrasound guided quadratus lumborum block has been described as an analgesic technique in abdominal surgeries as well as in various lower limb surgeries (lateral or posterior QL block). It is performed through the injection of a local anaesthetic mixture between the lateral abdominal layers and QL muscle. The peculiar feature of this block is that it not only sensory nerves but also the visceral nerves. Peripheral nerve blocks provide longer and localized pain relief with early ambulation and also avoid the side effects of systemic medication. The major limiting factor with the use of local anaesthetic are their short duration of action and delayed onset. To overcome these shortcomings, adjuvant such as opioids, magnesium, ketamine etc have been used. In this study we will compare the duration of analgesia with two adjuvants dexamethasone and sodium bicarbonate with levobupivacaine. 
 
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