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CTRI Number  CTRI/2025/05/086596 [Registered on: 08/05/2025] Trial Registered Prospectively
Last Modified On: 07/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Comparision of an anaesthetic drug and a nerve block to study better postoperative pain relief. 
Scientific Title of Study   To compare the effictiveness of ultrasound guided Quadratus lumborum block using injection bupivacaine and intravenous tramadol for postoperative analgesia in unilateral renal surgeries- A randomised comparative study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Karumuri Venkata Jayabala 
Designation  Junior Resident 
Affiliation  Mahatma Gandhi Memorial Medical College and M.Y.Hospital, Indore. 
Address  Department of Anaesthesiology, Mahatma Gandhi Memorial Medical College and M.Y.Hospital, Indore.

Indore
MADHYA PRADESH
452001
India 
Phone  6281017699  
Fax    
Email  jayabala.karumuri@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Deepali Valecha 
Designation  Assistant Professor 
Affiliation  Department of Anaesthesiology, Mahatma Gandhi Memorial Medical College and M.Y.Hospital, Indore. 
Address  Department of Anaesthesiology, Mahatma Gandhi Memorial Medical College and M.Y.Hospital, Indore.

Indore
MADHYA PRADESH
452001
India 
Phone  9424405405  
Fax    
Email  deepalisidhwani@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Deepali Valecha 
Designation  Assistant Professor 
Affiliation  Department of Anaesthesiology, Mahatma Gandhi Memorial Medical College and M.Y.Hospital, Indore. 
Address  Department of Anaesthesiology, Mahatma Gandhi Memorial Medical College and M.Y.Hospital, Indore.

Indore
MADHYA PRADESH
452001
India 
Phone  9424405405  
Fax    
Email  deepalisidhwani@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, Mahatma Gandhi Memorial Medical college and M.Y.Hospital, Indore, Madhya Pradesh, India. Pincode 452001 
 
Primary Sponsor  
Name  Mahatma Gandhi Memorial Medical college and MYHospital 
Address  Department of Anaesthesiology, Mahatma Gandhi Memorial Medical college and M.Y.Hospital, Indore, Madhya Pradesh, India. Pincode 452001 
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 
Karumuri Venkata Jayabala  Mahatma Gandhi Memorial Medical College and M.Y.Hospital, Indore, Madhya Pradesh  Ground floor, Operation theatre Complex, Department of Anaesthesiology office, M.Y.Hosoital, Indore, Madhya Pradesh, India. Pincode 452001.
Indore
MADHYA PRADESH 
6281017699

jayabala.karumuri@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics and Scientific Review committee, M.G.M Medical college & M.Y.Hospital, Indore.  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Injection tramadol 1.5mg per kg  At the end of surgery other group of patients will receive injection tramadol 1.5mg per kilogram for post operative analgesia in unilateral renal surgery patients as a single bolus intravenous administration.  
Intervention  Quadratus lumborum block using injection Bupivacaine  At the end of surgery and before extubation one group of patients are given Quadratus lumborum block for post operative analegesia in unilateral renal surgeries patient using injection bupicacaine 0.25% 25ml as a single bolus injection. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Informed consent, Physical status ASA I, II, III and age group between 18 to 65 years 
 
ExclusionCriteria 
Details  Patient refusal, Any contraindications to regional anaesthesia and those who are allergic to local anaesthesia, Patients with coagulation abnormalities, obese patients with BMI more than 29.9 kg/m2. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the duration of postoperative analgesia in two groups.  To compare the duration of postoperative analgesia in two groups upto 24 hours at different time intervals. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the total consumption of analgesia in the first 24 hours.  Total analgesic requirement in both groups will be monitored upto 24 hours postoperatively at different time intervals depending on patient complaints. 
To assess complications or side effects if any.  To assess for complications like nausea, vomiting, hypotension, bradycardia if any within 24 hours postoperatively any time if they occur within 24 hours. 
 
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 4 
Date of First Enrollment (India)   18/05/2025 
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 Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 01-05-2025 and end date provided 01-05-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

INTRODUCTION

 Despite advances in both surgical and anaesthesia techniques, post operative pain remains an important concern in patients undergoing renal surgeries. The postoperative pain following surgical procedures not only prolongs the duration of hospital stay but also increases morbidity and effect enhanced recovery programs. Peripheral nerve blocks and interfascial plane blocks are considered safer, providing long lasting analgesia as compared to central neuraxial blockade, and systemic analgesia (i/v, oral) facilitating lesser morbidity and early discharges. Main advantage of Quadratus lumborum block is that it provides higher dermatome coverage (T6-L1), better sensory coverage and visceral analgesia.The ultrasound is a valuable adjunct in peripheral nerve block practice due to clarity and direct visualisation of anatomical landmarks providing better and long lasting blockage with lesser complications. Hence, this study aims to evaluate the analgesic efficacy of ultrasound guided Quadratus lumborum block for postoperative analgesia in patients undergoing unilateral renal surgeries.

 

METHODOLOGY

The day before surgery pre anaesthetic assessment of all patients will be done and all the patients will be explained about the NBM period, visual analogue scale (VAS score) and study protocol in their local vernacular language and written informed consent will be obtained for the same. Patients will be divided into two groups by odd and even method (30 in each group). Patients in group A will be given ultrasound guided quadratus lumborum block and patients in group B will be given Inj. Tramadol 1.5mg/kg as analgesic at the end of surgery. General anaesthesia will be standardised to all patients. Inj.Fentanyl 1mcg/kg will be administered as a top up after 60 minutes from onset of surgery.  At the end of surgery, patients of Group A will receive Quadratus lumborum block (type: anterior Shamrock’s approach) in lateral position using an ultrasound machine with a curvilinear 2-5 MHz probe using Inj. Bupivacaine 0.25% 25ml. Patients of Group B will receive Inj.Tramadol 1.5mg/kg at the end of surgery.  Haemodynamic parameters of the patient will be monitored at every 5 minutes interval till 20 minutes after giving the block and then every 20 minutes till 2 hours. After extubation, the pain will be assessed by the VAS scale of 1-10, 30 minutes post procedure till 2 hour, then at 4, 8, 12, 18, 24 hour. The patients will be administered Inj.Tramadol 1.5mg/kg if their VAS score >3 and the time duration from administration of block to VAS > 3 will be considered as duration of analgesia. The patients will be monitored from the time of extubation to 24 hours postoperatively and total consumption of Inj. Tramadol in this period will be noted. The incidence of adverse effects such as nausea, vomiting, hypotension, tachycardia etc., will be noted down and treated accordingly.

REFERENCES

1.     Venkatraman R, Saravanan R, Mohana KV, Pushparani A. Evaluation of ultrasound guided quadratus lumborum block for postoperative analgesia in unilateral laparoscopic renal surgeries – A randomised controlled trial. Indian J Anaesth 2020;64:1007-11.

2.     Sindwani G, Sahu S, Suri A, Sureka S, Thomas M. Efficacy of ultrasound guided quadratus lumborum block as postoperative analgesia in renal transplantation recipients: A randomised double blind clinical study. Indian J Anaesth 2020;64:605-10.

3.     Raman R, Prabha R. Quadratus lumborum block for patients undergoing percutaneous nephrolithotomy: A randomized controlled study. Anesth Essays Res 2021;15:174-8.

4.     Kerai, Sukhyanti; Saxena, Kirti Nath1. Quadratus lumborum block for post-caesarean analgesia. Indian Journal of Anaesthesia 61(4):p 364, April 2017. | DOI: 10.4103/ija.IJA_220_17 .

5.     Verma K, Malawat A, Jethava D, Jethava DD. Comparison of transversus abdominis plane block and quadratus lumborum block for post-caesarean section analgesia: A randomised clinical trial. Indian J Anaesth 2019;63:820-

6.     Sindwani G, Sahu S, Suri A, Saeed Z. Bilateral quadratus lumborum block for postoperative analgesia in a Von Hippel-Lindau syndrome patient undergoing laparoscopic radical nephrectomy. Saudi J Anaesth 2017;11:513-4.

7.     Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol 2015;32:812-8.

8.     Blanco R, Ansari T, Riad W, Shetty N. Quadratus lumborum block versus transversus abdominis plane block for postoperative pain after cesarean delivery: A randomized controlled trial. Reg Anesth Pain Med 2016;41:757-62.

9.     Krohg A, Ullensvang K, Rosseland LA, Langesæter E, Sauter AR. The analgesic effect of ultrasound-guided quadratus lumborum block after cesarean delivery: A randomized clinical trial. Anesth Analg 2018;126:559-65.

10.  Ökmen K, Ökmen BM. Ultrasound-guided anterior quadratus lumborum block for postoperative pain after percutaneous nephrolithotomy: A randomized controlled trial. Korean J Anesthesiol 2020;73:44-50.

 
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